Conditions: 22q11 Deletion Syndrome
Keywords: 22q11 Deletion Syndrome 22q11.2 Deletion Syndrome 22q11DS Children and Adolescents
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 37
Healthy volunteers: no

Brief summary:
This is a Phase 2, randomized, placebo-controlled crossover trial to assess the safety and efficacy of NB-001 in children and adolescents with 22q11DS that manifest commonly associated neuropsychiatric symptoms.

Detailed description:
The trial is designed to allow all visits to be conducted via telephone and/or video (i.e., telemedicine) or by home health nurse. An in-person visit is required at Screening unless site or government mandates restrict this due to coronavirus disease-2019 (COVID-19). Other in-person visit(s) may occur, if indicated, based on the Investigator's clinical judgement. Subjects will be screened to confirm eligibility and then randomized in a 1:1 ratio to one of two treatment sequences: NB-001 (active drug product) followed by placebo (treatment sequence A/P) or placebo followed by NB-001 (treatment sequence P/A). During the Double-Blind Treatment Phase of the trial, the subject and/or parent/legal guardian (henceforth, 'parent/guardian') will be contacted at Day 0 to complete baseline symptom scales and will begin dosing with the investigational product (IP; NB-001 or placebo) on the morning of Day 1. Subjects or their parent/guardian will administer the IP twice daily (BID) and will be contacted at Days 0, 1, 14, 28, 42, 49, 50, 63, 77 and 91 to evaluate measures of safety and efficacy, including the completion of symptom scales. In addition, the subject and/or parent/guardian will be contacted at Days 7, 21, 35, 56, 70 and 84 to assess subject safety. Blood samples for pharmacokinetic analysis, 4β-hydroxycholesterol and plasma proline will be collected at multiple timepoints. During the Double-Blind Treatment Phase, subjects will receive IP corresponding with their first treatment assignment for 6 weeks (Treatment Period 1), followed by an intervening wash-out period of 1 week, and then will receive their second treatment assignment for the subsequent 6-week period (Treatment Period 2). All symptom scales will be centrally and/or locally administered. Approximately 10 parents/guardians and paired clinical trial site clinicians for subjects who complete the trial per protocol through Visit Day 91 will be invited to participate in an optional, one-hour (approximately), exit interview to discuss the observations of the subject's experience(s) and functioning while participating in the treatment periods of the trial. The subject and/or parent/guardian will be contacted for an End of Trial Visit to occur 4 weeks following the last dose of IP to assess safety.

Arms:
arm 1: Two (2) 100 mg capsules administered orally BID (400 mg total daily dose) with liquids or, if the subject is unable to swallow a capsule whole, capsules were opened, and the contents sprinkled on applesauce. arm 2: Two (2) capsules (matching, inactive) administered orally BID with liquids or, if the subject is unable to swallow a capsule whole, capsules were opened, and the contents sprinkled on applesauce.

Interventions: intervention 1: NB-001 intervention 2: Placebo
Intervention descriptions: intervention 1: Non-stimulant modulator of metabotropic glutamate receptors (mGluRs) intervention 2: Matching, inactive placebo

Protocol document:
Prot_000.pdf: 
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Page 127 of 128


Page 128 of 128

SAP_001.pdf: 




N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 3 o f 2 8
T A B L E O F C O N T E N T S
S T A T IS T IC A L A N A L Y S IS P L A N A P P R O V A L ........................................................2
T A B L E O F C O N T E N T S ...............................................................................................3
T A B L E O F T A B L E S ....................................................................................................5
T A B L E O F F IG U R E S ...................................................................................................5
A B B R E V IA T IO N S .......................................................................................................6
1 .
IN T R O D U C T IO N .................................................................................................8
2 .
S T U D Y O B JE C T IV E S ..........................................................................................8
2 .1
P rim ary S tu d y O b jectiv e .................................................................................8
2 .2
S eco n d ary S tu d y O b jectiv es............................................................................8
3 .
IN V E S T IG A T IO N A L P L A N ................................................................................9
3 .1
O v erall S tu d y D esig n ......................................................................................9
3 .2
S ch ed u le o f A ssessm en ts ..............................................................................1 0
3 .3
T reatm en ts .....................................................................................................1 0
3 .3 .1
T reatm en ts A d m in istered .......................................................................1 0
3 .3 .2
M eth o d o f A ssig n in g S u b jects to T reatm en t G ro u p s.............................1 0
3 .3 .3
B lin d in g P ro ced u res...............................................................................1 0
3 .4
E fficacy an d S afety V ariab les .......................................................................1 1
3 .4 .1
E fficacy V ariab les..................................................................................1 1
3 .4 .2
S afety V ariab les .....................................................................................1 2
3 .5
D ata Q u ality A ssu ran ce .................................................................................1 4
4 .
S T A T IS T IC A L M E T H O D S ................................................................................1 5
4 .1
G en eral M eth o d o lo g y ....................................................................................1 5
4 .1 .1
R ep o rtin g C o n v en tio n s ..........................................................................1 5
4 .1 .2
S u m m arizatio n b y V isit .........................................................................1 6
4 .1 .3
D ata H an d lin g R u les ..............................................................................1 6
4 .1 .4
S tan d ard C alcu latio n s ............................................................................1 7
4 .2
A n aly sis S ets .................................................................................................1 7
4 .3
S tu d y S u b jects ...............................................................................................1 8
4 .3 .1
D isp o sitio n o f S u b jects ..........................................................................1 8
4 .3 .2
P ro to co l D ev iatio n s................................................................................1 8
4 .4
E fficacy E v alu atio n .......................................................................................1 8
4 .4 .1
D atasets A n aly zed ..................................................................................1 8
4 .4 .2
D em o g rap h ic an d O th er B aselin e C h aracteristics .................................1 8
4 .4 .3
M easu rem en ts o f T reatm en t C o m p lian ce ..............................................1 9
4 .4 .4
P rim ary E fficacy E n d p o in t A n aly sis M eth o d s ......................................1 9
4 .4 .5
S eco n d ary E n d p o in t A n aly sis M eth o d s .................................................2 0


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 4 o f 2 8
4 .4 .6
A d d itio n al E fficacy E n d p o in t A n aly sis M eth o d s ..................................2 0
4 .4 .7
S tatistical/A n aly tical Issu es ...................................................................2 1
4 .4 .8
P lasm a C o n cen tratio n s...........................................................................2 3
4 .4 .9
P h arm aco k in etic A n aly sis......................................................................2 3
4 .5
S afety E v alu atio n ..........................................................................................2 3
4 .5 .1
E x ten t o f E x p o su re .................................................................................2 4
4 .5 .2
A d v erse E v en ts ......................................................................................2 4
4 .5 .3
D eath s, O th er S erio u s A d v erse E v en ts, an d O th er S ig n ifican t A d v erse
E v en ts
2 5
4 .5 .4
C lin ical L ab o rato ry E v alu atio n ..............................................................2 5
4 .5 .5
V ital S ig n s, P h y sical F in d in g s, an d O th er O b serv atio n s R elated to
S afety
2 6
4 .6
D eterm in atio n o f S am p le S ize.......................................................................2 7
4 .7
C h an g es in th e C o n d u ct o f th e S tu d y o r P lan n ed A n aly ses ..........................2 7
5 .
R E F E R E N C E L IS T .............................................................................................2 8


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 5 o f 2 8
T A B L E O F T A B L E S
T ab le 1
L ist o f A b b rev iatio n s ...................................................................................6
T ab le 2
C lin ical L ab o rato ry T ests ..........................................................................1 3
T A B L E O F F IG U R E S
F ig u re 1
T rial D esig n .................................................................................................9


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 6 o f 2 8
A B B R E V IA T IO N S
T a b le 1
L ist o f A b b rev ia tio n s
A b b rev iatio n
D efin itio n
2 2 q 1 1 D S
2 2 q 1 1 .2 D eletio n S y n d ro m e
A D H D
atten tio n d eficit h y p eractiv ity d iso rd er
A D H D -R S -5
A tten tio n D eficit H y p eractiv ity D iso rd er-R atin g S cale-5
A E
ad v erse ev en t
A S D
au tism sp ectru m d iso rd er
A T C
A n ato m ical T h erap eu tic C h em ical
B ID
tw ice d aily
B M I
b o d y m ass in d ex
C G I
C lin ical G lo b al Im p ressio n
C G I-I
C lin ical G lo b al Im p ressio n – Im p ro v em en t
C G I-S
C lin ical G lo b al Im p ressio n – S ev erity
C I
co n fid en ce in terv al
C O V ID -1 9
co ro n av iru s d isease 2 0 1 9
C -S S R S
C o lu m b ia– S u icid e S ev erity R atin g S cale
C S R
clin ical stu d y rep o rt
C T C A E
C o m m o n T erm in o lo g y C riteria fo r A d v erse E v en ts
D S M -5
D iag n o stic an d S tatistical M an u al o f M en tal D iso rd ers,
F ifth E d itio n
eC R F
electro n ic case rep o rt fo rm
E C G
electro card io g ram
E O T
en d o f trial
E N R
E n ro lled A n aly sis S et
E T
early term in atio n
F A S
F u ll A n aly sis S et
G A D
G en eralized A n x iety D iso rd er
IC H
In tern atio n al C o u n cil fo r H arm o n isatio n
IP
in v estig atio n al p ro d u ct
M ed D R A
M ed ical D ictio n ary fo r R eg u lato ry A ctiv ities
O L S
O rd in ary least sq u ares
P A R S
P ed iatric A n x iety R atin g S cale
P K
p h arm aco k in etic
P P S
P er P ro to co l S et
Q 1
1 st q u artile (2 5 th p ercen tile)
Q 3
3 rd q u artile (7 5 th p ercen tile)
O L S
o rd in ary least sq u ares
Q T c
co rrected Q T
S A E
serio u s ad v erse ev en t
S A F
S afety A n aly sis S et


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 7 o f 2 8
A b b rev iatio n
D efin itio n
S A P
S tatistical A n aly sis P lan
S A D
sep aratio n an x iety d iso rd er
S D
stan d ard d ev iatio n
S E
stan d ard erro r
S I
S y stèm e In tern atio n al
S IB
su icid al id eatio n an d b eh av io r
S o P
so cial p h o b ia
S R S T M -2
S o cial R esp o n siv en ess S cale, S eco n d E d itio n
T E A E
treatm en t-em erg en t ad v erse ev en t
T E A E -S I
treatm en t-em erg en t ad v erse ev en t o f sp ecial in terest
W H O D D E
W o rld H ealth O rg an izatio n D ru g D ictio n ary E n h an ced


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 8 o f 2 8
1 . IN T R O D U C T IO N
T h e p u rp o se o f th is S tatistical A n aly sis P lan (S A P ) is to p ro v id e co m p reh en siv e an d
d etailed d escrip tio n s o f th e m eth o d s an d p resen tatio n o f d ata an aly ses p ro p o sed fo r
N o b ias T h erap eu tics, In c. P ro to co l N B -0 0 1 -0 1 (A
ran d o m ized , p laceb o -co n tro lled
cro sso v er trial to assess th e safety an d efficacy o f N B -0 0 1 in ch ild ren an d ad o lescen ts
w ith 2 2 Q 1 1 D eletio n S y n d ro m e [2 2 Q 1 1 D S ]). D escrip tio n s o f p lan n ed an aly ses are
p ro v id ed in o rd er to av o id p o st h o c d ecisio n s th at m ay affect th e in terp retatio n o f th e
statistical an aly sis. T h e statistical m eth o d s ap p lied in th e d esig n an d p lan n ed an aly ses
o f th is stu d y are co n sisten t w ith th e In tern atio n al C o u n cil fo r H arm o n isatio n (IC H )
g u id elin es S ta tistica l P rin cip les fo r C lin ica l T ria ls (E 9 ) (1 9 9 8 ) an d
S ta tistica l
P rin cip a ls fo r C lin ica l T ria ls: A d d en d u m : E stim a n d s a n d S en sitivity A n a lysis in
C lin ica l T ria ls (E 9 [R 1 ]) (2 0 1 7 ).
T h is S A P w ill b e fin alized p rio r to d ata an aly sis an d b efo re treatm en t u n b lin d in g an d
d atab ase lo ck to p ro v id e co m p reh en siv e d etails o f th e tab les, fig u res, an d listin g s to b e
p resen ted in th e C lin ical S tu d y R ep o rt (C S R ). A n y ch an g es b etw een th e statistical
m eth o d s p ro v id ed in th e clin ical stu d y p ro to co l an d th is S A P w ill b e ex p lain ed h erein ;
an y ch an g es o r d ev iatio n s fro m
th is S A P relativ e to th e fin al an aly sis w ill b e fu lly
d o cu m en ted in th e C S R . M in o r ch an g es o r d ev iatio n s fro m
th e tem p lates fo r tab les,
fig u res, an d listin g s n eed n o t b e d o cu m en ted in th e C S R .
2 . S T U D Y O B J E C T IV E S
2 .1
P rim a ry S tu d y O b jectiv e
T h e p rim ary o b jectiv e o f th is stu d y is to assess th e safety an d to lerab ility o f N B -0 0 1
d u rin g 6 w eek s o f treatm en t w ith N B -0 0 1 in su b jects w ith 2 2 q 1 1 D S .
2 .2
S eco n d a ry S tu d y O b jectiv es
T h e seco n d ary o b jectiv es o f th is stu d y are to assess:
•
T h e efficacy o f N B -0 0 1 after 6 w eek s o f treatm en t w ith N B -0 0 1 u sin g th e
C lin ical G lo b al Im p ressio n (C G I) en d p o in t;
•
T h e efficacy o f N B -0 0 1 u sin g a scale sp ecific to th e fo llo w in g d o m ain /sy m p to m
o f g reatest im p airm en t fo r each su b ject b ased u p o n b aselin e clin ical assessm en t:
!
A n x iety (g en eralized an x iety d iso rd er [G A D ], so cial p h o b ia [S o P ], o r
sep aratio n an x iety d iso rd er [S A D ]);
!
A tten tio n an d ex ecu tiv e d eficits (i.e., atten tio n d eficit h y p eractiv ity
d iso rd er [A D H D ]);
!
S o cial in teractio n an d rep etitiv e ten d en cies (i.e., au tism sp ectru m
d iso rd er [A S D ]);
•
T h e efficacy o f N B -0 0 1 u sin g scales sp ecific to th e ad d itio n al sy m p to m
d o m ain s ab o v e.


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 9 o f 2 8
3 . IN V E S T IG A T IO N A L P L A N
3 .1
O v era ll S tu d y D esig n
T h is is a P h ase 2 , ran d o m ized , p laceb o -co n tro lled cro sso v er trial to assess th e safety
an d efficacy o f N B -0 0 1 in ch ild ren an d ad o lescen ts w ith 2 2 q 1 1 D S th at m an ifest
co m m o n ly asso ciated n eu ro p sy ch iatric co n d itio n s.
A p p ro x im ately 3 4 su b jects w ill b e ran d o m ized acro ss 3 -5 trial cen ters lo cated in th e
U n ited S tates an d C an ad a. A d d itio n al su b jects m ay b e en ro lled , at th e d iscretio n o f th e
S p o n so r, to rep lace su b jects w h o term in ate early fro m th e trial.
T h e trial is d esig n ed to allo w all v isits to b e co n d u cted v ia telem ed icin e o r b y a h o m e
h ealth n u rse. A n in -p erso n v isit is req u ired at S creen in g u n less site o r g o v ern m en t
m an d ates restrict th is d u e to co ro n av iru s d isease 2 0 1 9 (C O V ID -1 9 ). O th er in -p erso n
v isits m ay o ccu r, if in d icated , b ased o n th e In v estig ato r’s clin ical ju d g em en t.
S u b jects w ill b e screen ed to co n firm elig ib ility an d th en ran d o m ized in a 1 :1 ratio to
o n e o f tw o treatm en t seq u en ces: N B -0 0 1 fo llo w ed b y p laceb o o r p laceb o fo llo w ed b y
N B -0 0 1 .
S u b jects w ill receiv e in v estig atio n al p ro d u ct (IP ) co rresp o n d in g w ith th e first treatm en t
assig n m en t fo r 6 w eek s (T reatm en t P erio d 1 ). T h is w ill b e fo llo w ed b y an in terv en in g
w ash -o u t p erio d o f 1 w eek , an d th en su b jects w ill receiv e th eir seco n d treatm en t
assig n m en t fo r th e su b seq u en t 6 -w eek p erio d (T reatm en t P erio d 2 ). T h e w ash -o u t
p erio d m ay b e ex ten d ed b ey o n d o n e w eek (an d w ith in reaso n ) to acco m m o d ate th e
su b ject’s sch ed u le, after co n su ltatio n w ith th e C lin ical R esearch A sso ciate o r M ed ical
M o n ito r. D u rin g th e D o u b le-B lin d T reatm en t P h ase, th e su b ject an d /o r p aren t/g u ard ian
w ill b e co n tacted at D ay 0 to co m p lete b aselin e sy m p to m scales an d w ill b eg in d o sin g
w ith th e IP (N B -0 0 1 o r p laceb o ) o n th e m o rn in g o f D ay 1 .
S u b jects o r th eir p aren t/g u ard ian w ill ad m in ister th e IP tw ice d aily (B ID ) an d w ill b e
co n tacted at D ay s 0 , 1 , 1 4 , 2 8 , 4 2 , 4 9 , 5 0 , 6 3 , 7 7 an d 9 1 to ev alu ate m easu res o f safety
an d efficacy , in clu d in g th e co m p letio n o f sy m p to m scales. A ll sy m p to m scales w ill b e
cen trally an d /o r lo cally ad m in istered . In ad d itio n , th e su b ject an d /o r p aren t/g u ard ian
w ill b e co n tacted at D ay s 7 ,2 1 ,3 5 ,5 6 ,7 0 an d 8 4 to assess su b ject safety .B lo o d sam p les
fo r p h arm aco k in etic (P K ) an aly sis, 4 β ‐h y d ro x y ch o lestero l an d p lasm a p ro lin e w ill b e
co llected at th e tim ep o in ts n o ted in th e sch ed u le o f assessm en ts.
T h e su b ject an d /o r p aren t/g u ard ian w ill b e co n tacted fo r an E n d o f T rial (E O T ) V isit to
o ccu r 4 w eek s fo llo w in g th e last d o se o f IP to assess safety . If th e In v estig ato r p erceiv es
a su b ject is ex p erien cin g clin ical b en efit to treatm en t an d th e su b ject h as co m p leted th e
trial, p ro v isio n s m ay b e m ad e to allo w
th e su b ject to co n tin u e to receiv e N B -0 0 1 .
D etails w ill b e p ro v id ed in a sep arate o p en -lab el ex ten sio n p ro to co l.
A sch em atic o f th e trial d esig n is p ro v id ed in th e fig u re b elo w .
F ig u re 1
T ria l D esig n


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 1 0 o f 2 8
3 .2
S ch ed u le o f A ssessm en ts
F o r th e co m p lete sch ed u le o f assessm en ts, refer to T ab le 3 in S ectio n 6 .1 o f th e clin ical
stu d y p ro to co l.
3 .3
T rea tm en ts
3 .3 .1
T rea tm en ts A d m in istered
D u e to th e cro ss-o v er stu d y d esig n , all su b jects w ill receiv e b o th N B -0 0 1 an d p laceb o
cap su les. E ach N B -0 0 1 cap su le co n tain s 1 0 0 m g o f th e activ e in g red ien t. P laceb o
cap su les co n tain ex cip ien ts o n ly an d m atch th e N B -0 0 1 cap su les in ap p earan ce.
N B -0 0 1 an d m atch in g p laceb o w ill b e su p p lied to th e In v estig ato r o r d esig n ee in
b lin d ed p lastic b o ttles, each co n tain in g 4 0 cap su les.
N B -0 0 1 o r p laceb o cap su les w ill b e ad m in istered o rally to th e su b ject. S u b jects w ill
tak e tw o cap su les B ID , tw o in th e m o rn in g an d tw o in th e ev en in g (i.e., fo u r cap su les
d aily ). T h e su b ject w ill b eg in d o sin g fo r T reatm en t P erio d 1 o n th e m o rn in g o f D ay 1 ,
after co llectio n o f p re-d o se sam p les. S im ilarly , th e su b ject w ill b eg in d o sin g fo r
T reatm en t P erio d 2 o n th e m o rn in g o f D ay 5 0 after co llectio n o f p re-d o se sam p les.
3 .3 .2
M eth o d o f A ssig n in g S u b jects to T rea tm en t G ro u p s
U p o n co n firm atio n o f trial elig ib ility , su b jects w ill b e ran d o m ized at th e co n clu sio n o f
th e S creen in g V isit. R an d o m izatio n w ill o ccu r in a 1 :1 ratio to o n e o f tw o treatm en t
seq u en ces: N B -0 0 1 fo llo w ed b y p laceb o o r p laceb o fo llo w ed b y N B -0 0 1 .
3 .3 .3
B lin d in g P ro ced u res
T h e ran d o m izatio n sch em e w ill b e g en erated u sin g a co m p u ter p ro g ram
an d v erified
fo r accu racy u sin g strict q u ality co n tro l p ro ced u res. E ach IP b o ttle w ill b e lab eled w ith
a u n iq u e b o ttle n u m b er w h ich w ill co rresp o n d to th e ran d o m izatio n co d e an d b lin d ed
treatm en t assig n m en t.
In th e ev en t o f a m ed ical em erg en cy in w h ich it is im p o rtan t fo r th e treatin g p h y sician
to k n o w
th e treatm en t assig n m en t, th e b lin d m ay b e b ro k en b y th e In v estig ato r.
W h en ev er p o ssib le (i.e., if tim e allo w s), th e In v estig ato r w ill co n tact th e M ed ical


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 1 1 o f 2 8
M o n ito r, o r d esig n ee, p rio r to accessin g th e treatm en t co d e fo r th e su b ject. In stru ctio n s
fo r em erg en cy u n b lin d in g o f treatm en t co d es b y th e In v estig ato r w ill b e p ro v id ed in a
sep arate d ata access p lan .
3 .4
E ffica cy a n d S a fety V a ria b les
3 .4 .1
E ffica cy V a ria b les
3 .4 .1 .1 P rim a ry E ffica cy V a ria b le
T h e p rim ary efficacy en d p o in t is th e C lin ical G lo b al Im p ressio n -Im p ro v em en t (C G I-I)
sco re p er th e cen tral rater.
T h e C G I-I scale w ill b e p erfo rm ed b y a cen tral rater an d w h ere p o ssib le (i.e., o p tio n al),
a lo cal rater. T h e C G I-I assessm en ts at D ay s 1 4 , 2 8 , 4 2 an d 4 9 w ill u se th e D ay 0
C lin ical G lo b al Im p ressio n -S ev erity (C G I-S ) b aselin e ratin g as a referen ce fo r ch an g e.
T h e C G I-I assessm en ts at D ay s 6 3 , 7 7 , 9 1 an d 1 1 9 w ill u se th e D ay 4 9 C G I-S b aselin e
ratin g as referen ce fo r ch an g e.
T h e C G I-S scale w ill b e u sed to estab lish th e d eg ree o f d isease sev erity fo r each su b ject.
T h e C G I-I scale w ill b e u sed as an o u tco m e m easu re fo r estim atin g lev el o f fu n ctio n in g
in resp o n se to treatm en t. T h e clin ician ’s g lo b al assessm en ts o f th e sev erity o f th e
sy m p to m s an d ch an g es in sy m p to m s fro m b aselin e (D ay 0 o r D ay 4 9 , p er ab o v e) w ill
b e b ased o n rep o rts fro m
th e su b ject an d /o r p aren t/g u ard ian , an d m in im al d irect
o b serv atio n (G u y 1 9 7 6 ; B u sn er an d T arg u m 2 0 0 7 ).
A t th e v isits n o ted in th e sch ed u le o f assessm en ts, th e rater(s) w ill assess th e su b ject’s
im p ro v em en t relativ e to h is/h er sy m p to m s at b aselin e (D ay 0 o r D ay 4 9 , p er ab o v e)
u sin g a 7 -p o in t scale ran g in g fro m 1 (v ery m u ch im p ro v ed ) to 7 (v ery m u ch w o rse).
3 .4 .1 .2 S eco n d a ry E ffica cy V a ria b les
S eco n d ary efficacy en d p o in ts in clu d e th e fo llo w in g assessm en ts:
C G I-S
T h e C G I-S scale w ill b e u sed to rate th e sev erity o f th e su b ject’s co n d itio n o n a 7 -p o in t
scale ran g in g fro m
1 (N o rm al, n o t at all ill) to 7 (A m o n g th e m o st ex trem ely ill
su b jects). It w ill b e ad m in istered at S creen in g an d D ay s 0 an d 4 9 p rio r to d o sin g , an d
at ad d itio n al v isits n o ted in th e sch ed u le o f assessm en ts.
P ed ia tric A n xiety R a tin g S ca le (P A R S )
T h e P A R S is a clin ician -rated in stru m en t fo r assessin g , o v er tim e, th e sev erity o f
an x iety sy m p to m s th at are asso ciated w ith co m m o n D iag n o stic an d S tatistical M an u al
o f M en tal D iso rd ers, F ifth E d itio n (D S M -5 ) (A m erican P sy ch iatric A sso ciatio n 2 0 1 3 ),
an x iety d iso rd ers (G A D , S A D , an d S o P ) in su b jects ag ed 6 to 1 7 y ears. T h e P A R S
in clu d es tw o sectio n s. T h e first sectio n is a 5 0 -item
sy m p to m
ch eck list, w h ich th e
clin ician rates as p resen t o r ab sen t d u rin g th e p ast w eek . T h e seco n d sectio n is
co m p rised o f 7 sev erity /im p airm en t item s th at are rated o n a 6 -p o in t L ik ert scale. T h e
7 sev erity /im p airm en t item s reflect th e sev erity /im p airm en t o f all sy m p to m s n o ted in


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 1 2 o f 2 8
S ectio n 1 o f th e P A R S (d u rin g th e p rev io u s w eek ) (R esearch U n its o n P ed iatric
P sy ch o p h arm aco lo g y A n x iety S tu d y G ro u p 2 0 0 2 ).T h e clin ician w ill in terv iew b o th th e
su b ject an d th e p aren t/g u ard ian to co m p lete th is assessm en t at th e v isits d escrib ed in
th e sch ed u le o f assessm en ts. T h e P A R S sev erity sco re is calcu lated as th e su m o f item s
2 , 3 , 5 , 6 , an d 7 an d w ill b e p ro v id ed in th e ex tern al d ata tran sfer alo n g w ith th e
in d iv id u al item sco res.
A tten tio n D eficit H yp era ctivity D iso rd er-R a tin g S ca le-5 (A D H D -R S -5 )
T h e A D H D -R S -5 w ill b e ad m in istered at th e v isits n o ted in th e sch ed u le o f assessm en ts
to d o cu m en t th e su b ject’s A D H D sy m p to m s o v er th e p rev io u s w eek . T h e A D H D -R S -
5 H o m e V ersio n is a p aren t/g u ard ian rep o rted scale th at w as d ev elo p ed to m easu re th e
b eh av io rs o f ch ild ren w ith A D H D , w ith sep arate fo rm s fo r ch ild ren (ag es 5 -1 0 y ears)
an d ad o lescen ts (1 1 -1 7 y ears).T h e A D H D -R S -5 co n sists o f 1 8 item s d esig n ed to reflect
th e sy m p to m ato lo g y o f A D H D b ased o n th e D S M -5 criteria. E ach item w ill b e sco red
o n a scale ran g in g fro m 0 (reflectin g n o sy m p to m s) to 3 (reflectin g sev ere sy m p to m s).
T h e
1 8
item s
w ill
b e
g ro u p ed
in to
tw o
su b scales:
in atten tio n
an d
h y p eractiv ity /im p u lsiv ity . T h e In atten tio n su b scale raw sco re is co m p u ted b y su m m in g
th e item sco res fo r Item s 1 th ro u g h 9 an d th e H y p eractiv ity -Im p u lsiv ity su b scale raw
sco re is co m p u ted b y su m m in g th e item sco res fo r Item s 1 0 th ro u g h 1 8 . B o th su b scale
sco res w ill b e reco rd ed o n th e electro n ic case rep o rt fo rm (eC R F ).
A d d itio n ally , th e A D H D -R S -5 in co rp o rates tw o im p airm en t scales k ey ed to th e
in atten tio n an d h y p eractiv ity -im p u lsiv ity d im en sio n s, w h ich allo w
th e clin ician to
assess th e ex ten t to w h ich A D H D -related p ro b lem s ad v ersely affect th e h o m e an d /o r
sch o o l fu n ctio n in g o f ch ild ren an d ad o lescen ts (D u P au l et al. 2 0 1 6 ). F u rth er d etails are
p ro v id ed in A p p en d ix 4 o f th e clin ical stu d y p ro to co l.
S o cia l R esp o n siven ess S ca le, S eco n d E d itio n (S R S T M -2 )
T h e S R S T M -2 id en tifies th e p resen ce an d sev erity o f so cial im p airm en t w ith in th e
au tism sp ectru m an d d ifferen tiates it fro m th at w h ich o ccu rs in o th er d iso rd ers. It is a
6 5 -item , p aren t co m p leted q u estio n n aire w h ich in co rp o rates 5 co n ten t areas o f so cial
d eficits: so cial aw aren ess, so cial co g n itio n , so cial co m m u n icatio n , so cial m o tiv atio n ,
an d au tistic m an n erism s. T h e S R S T M - 2 w ill b e p ro cto red b y th e lo cal rater an d d eriv ed
an d su b scale raw an d T -d ata sco res w ill b e rep o rted o n th e eC R F (C o n stan tin o et al.
2 0 0 3 ; C o n stan tin o an d G ru b er 2 0 0 5 ). F u rth er d etails are p ro v id ed in A p p en d ix 5 o f th e
clin ical stu d y p ro to co l.
3 .4 .2
S a fety V a ria b les
S afety assessm en ts w ill in clu d e m o n ito rin g an d reco rd in g o f ad v erse ev en ts (A E s),
clin ical lab o rato ry tests, v ital sig n m easu rem en ts, p h y sical ex am , electro card io g ram s
(E C G s), an d th e C o lu m b ia– S u icid e S ev erity R atin g S cale (C -S S R S ).
3 .4 .2 .1 A d verse E ven ts
A n A E is d efin ed as an y u n to w ard m ed ical o ccu rren ce in a clin ical in v estig atio n su b ject
ad m in istered an IP an d w h ich d o es n o t n ecessarily h av e a cau sal relatio n sh ip w ith th e
p ro d u ct. A n A E can th erefo re b e an y u n fav o rab le an d u n in ten d ed sig n (in clu d in g an
ab n o rm al lab o rato ry fin d in g ), sy m p to m , o r d isease tem p o rally asso ciated w ith th e u se


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 1 3 o f 2 8
o f a
p h arm aceu tical p ro d u ct, w h eth er o r n o t it is co n sid ered
related
to
th e
p h arm aceu tical p ro d u ct.
P re-ex istin g ev en ts th at in crease in freq u en cy o r sev erity in n atu re d u rin g o r as a
co n seq u en ce o f u se o f an IP w ill also b e co n sid ered as A E s. A n y m ed ical co n d itio n o r
clin ically sig n ifican t lab o rato ry ab n o rm ality w ith an o n set d ate b efo re th e d ate o f
in fo rm ed co n sen t sig n atu re is p re-ex istin g an d sh o u ld b e d o cu m en ted as m ed ical
h isto ry . A n y A E th at o ccu rs b etw een th e d ate o f in fo rm ed co n sen t sig n atu re an d th e
d ate/tim e o f first IP ad m in istratio n w ill b e co n sid ered a p re-treatm en t-em erg en t A E .
A n y A E th at o ccu rs after th e d ate/tim e o f first IP ad m in istratio n w ill b e co n sid ered a
treatm en t-em erg en t ad v erse ev en t (T E A E ).
A treatm en t-em erg en t ad v erse ev en t o f sp ecial in terest (T E A E -S I) is an A E o f scien tific
an d m ed ical co n cern sp ecific to th e S p o n so r’s IP /d ev ice o r p ro g ram ,w h ich m ay w arran t
o n g o in g m o n ito rin g an d /o r rap id co m m u n icatio n b y th e in v estig ato r to th e S p o n so r o r
d esig n ee. S u ch an ev en t m ig h t w arran t fu rth er in v estig atio n in o rd er to ch aracterize an d
u n d erstan d it. T E A E s-S I in th is trial w ill in clu d e: d ev elo p m en t o f p sy ch o tic sy m p to m s,
su icid al id eatio n
an d
b eh av io r (S IB ), seizu re, o v erd o se w ith
u n to w ard
m ed ical
seq u alae, an d co n firm ed cases o f C O V ID -1 9 .
A ll A E s w ill b e assessed fo r sev erity acco rd in g to th e C o m m o n T erm in o lo g y C riteria
fo r A d v erse E v en ts (C T C A E ) V ersio n 5 .0 (effectiv e 2 7 N o v em b er 2 0 1 7 ).
3 .4 .2 .2 L a b o ra to ry P a ra m eters
C lin ical lab o rato ry tests w ill in clu d e ch em istry , h em ato lo g y , an d u rin aly sis as listed
b elo w in T ab le 2 . S am p les w ill b e o b tain ed at th e S creen in g v isit, D ay 0 , D ay 4 2 , D ay
9 1 /E arly T erm in atio n (E T ), an d D ay 1 1 9 /E O T V isits.
T a b le 2
C lin ica l L a b o ra to ry T ests
C h em istry
H em a to lo g y
U rin a ly sis
A lk alin e p h o sp h atase
A sp artate am in o tran sferase
A lan in e am in o tran sferase
T o tal b iliru b in
T o tal p ro tein
A lb u m in
G lu co se
C arb o n d io x id e
B lo o d u rea n itro g en
C reatin in e
S o d iu m
P o tassiu m
C h lo rid e
C alciu m
H em o g lo b in
H em ato crit
M ean co rp u scu lar h em o g lo b in
M ean co rp u scu lar h em o g lo b in
co n cen tratio n
M ean co rp u scu lar v o lu m e
E ry th ro cy te co u n t
L eu k o cy te co u n t
N eu tro p h il co u n t an d p ercen tag e
L y m p h o cy te co u n t an d
p ercen tag e
M o n o cy te co u n t an d p ercen tag e
E o sin o p h il co u n t an d p ercen tag e
B aso p h il co u n t an d p ercen tag e
P latelet co u n t
G lu co se
P ro tein
S p ecific g rav ity
p H
N itrite
B iliru b in
U ro b ilin o g en
K eto n e
B lo o d
L eu k o cy te esterase
O th er
eG F R (S creen in g
o n ly , rev ised
S ch w artz
eq u atio n )


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 1 4 o f 2 8
O th er lab o rato ry tests w ill in clu d e seru m
an d u rin e p reg n an cy tests in fem ales o f
ch ild b earin g p o ten tial, an d u rin e d ru g tests.
R ep o rts co n tain in g th ese lab o rato ry test resu lts w ill b e g en erated b y th e lab o rato ry
p erfo rm in g th e tests. L ab o rato ry v alu es o u tsid e o f th e n o rm al ran g e w ill b e assessed fo r
clin ical sig n ifican ce b y th e In v estig ato r. A b n o rm al lab o rato ry tests m ay b e rep eated at
th e d iscretio n o f th e In v estig ato r o r S p o n so r.
3 .4 .2 .3 V ita l S ig n s
V ital sig n s w ill in clu d e b lo o d p ressu re (sy sto lic an d d iasto lic), h eart rate, resp irato ry
rate, an d tem p eratu re an d w ill b e p erfo rm ed after th e su b ject h as b een at rest in th e
seated p o sitio n fo r at least 5 m in u tes. V ital sig n s w ill b e assessed at th e S creen in g V isit
an d as clin ically in d icated p er th e sch ed u le o f assessm en ts.
3 .4 .2 .4 P h ysica l E xa m in a tio n
A co m p lete p h y sical ex am in atio n w ill b e p erfo rm ed at th e S creen in g V isit, D ay 0 , D ay
4 2 , D ay 9 1 /E T V isit, an d D ay 1 1 9 /E O T V isit, an d w ill in clu d e an assessm en t o f th e
fo llo w in g b o d y sy stem s: g en eral ap p earan ce; w eig h t; h eig h t (at th e S creen in g V isit
o n ly ) m en tal statu s; h ead , ey es, ears, n o se, an d th ro at; d erm ato lo g ic; card io v ascu lar;
resp irato ry ;
g astro in testin al;
m u scu lo sk eletal;
an d
n eu ro lo g ical
at
S creen in g .
A d d itio n al b o d y sy stem s m ay b e ex am in ed at th e In v estig ato r’s d iscretio n . A n
ab b rev iated , clin ically fo cu sed p h y sical ex am in atio n b ased o n th e In v estig ato r’s
clin ical ju d g em en t w ill b e ad m in istered at all o th er assessm en t in terv als o r as clin ically
in d icated .
3 .4 .2 .5 E lectro ca rd io g ra m
A 1 2 -lead E C G in trip licate w ill b e o b tain ed at th e at th e S creen in g V isit, D ay 0 , D ay
4 2 , D ay 9 1 /E T V isit, an d D ay 1 1 9 /E O T V isit, w ith th e su b ject in a su p in e p o sitio n
fo llo w in g at least a 5 -m in u te rest. T h e In v estig ato r w ill rev iew an d rep o rt th e resu lts o f
each E C G ; th e rev iew s o n D ay s 4 2 an d 9 1 w ill in clu d e a co m p ariso n o f each E C G to
th e D ay 0 E C G .
3 .4 .2 .6 C o lu m b ia -S u icid e S everity R a tin g S ca le
C o n sisten t w ith F o o d an d D ru g A d m in istratio n (F D A ) G u id an ce, G u id a n ce fo r
In d u stry S u icid a l Id ea tio n a n d B eh a vio r: P ro sp ective A ssessm en t o f O ccu rren ce in
C lin ica l T ria ls, (F D A 2 0 1 2 ), th e C -S S R S is u sed to ev alu ate S IB . T h e scale co n sists o f
1 0 categ o ries w ith b in ary resp o n ses (y es/n o ) to assess th e su b ject’s su icid al th o u g h ts.
A n ad d itio n al q u estio n reg ard in g self-in ju rio u s b eh av io r w ith o u t su icid al in ten t w ill b e
ev alu ated w ith a b in ary resp o n se (y es/n o ). T h e C -S S R S w ill b e u sed at th e v isits n o ted
in th e sch ed u le o f assessm en ts to ev alu ate th e su b ject’s su icid al ten d en cies.
3 .5
D a ta Q u a lity A ssu ra n ce
R ep o rt su m m aries w ill b e g en erated u sin g v alid ated B ase S A S ® so ftw are, v ersio n 9 .4
o r h ig h er, o n a P C o r serv er-b ased p latfo rm . A d d itio n al v alid ated so ftw are m ay b e u sed
to g en erate an aly ses, as n eed ed .


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 1 5 o f 2 8
A ll S A S p ro g ram s th at create o u tp u ts o r su p p o rtin g an aly sis d atasets w ill b e v alid ated
b y a seco n d statistical p ro g ram m er o r b io statistician . A t a m in im u m , v alid atio n o f
p ro g ram s w ill co n sist o f a rev iew o f th e p ro g ram lo g , rev iew o f o u tp u t o r d ataset fo rm at
an d stru ctu re, an d in d ep en d en t co n firm ato ry p ro g ram m in g to v erify o u tp u t resu lts o r
d ataset co n ten t. A d d itio n ally , all o u tp u ts w ill u n d erg o a rev iew b y a sen io r lev el team
m em b er b efo re fin alizatio n .
T h e co n ten t o f th e so u rce d ata w ill b e rev iew ed o n an o n g o in g b asis b y p ro ject statistical
p ro g ram m ers an d statistician s.D ata w ill b e ch eck ed fo r m issin g v alu es,in v alid reco rd s,
an d ex trem e o u tliers th ro u g h d efen siv e p ro g ram m in g ap p licatio n s, an aly sis-b ased ed it
ch eck s, an d o th er p ro g ram m atic testin g p ro ced u res. A ll fin d in g s w ill b e fo rw ard ed to
th e p ro ject d ata m an ag er fo r ap p ro p riate actio n an d reso lu tio n .
4 . S T A T IS T IC A L M E T H O D S
4 .1
G en era l M eth o d o lo g y
D ata w ill b e an aly zed b y E m an ate b io statistics p erso n n el. S tatistical an aly ses w ill b e
rep o rted w ith tab les, fig u res, an d listin g s, p resen ted in rich tex t fo rm at, an d u sin g
reco m m en d ed IC H n u m b erin g . O u tp u t sp ecificatio n s fo r all tab les, fig u res, an d listin g s
w ill b e in co n fo rm an ce w ith g u id elin es sp ecified b y th e IC H
in A p p en d ix 7 o f th e
E lectro n ic C o m m o n T ech n ical D o cu m en t S p ecificatio n (A p r 2 0 0 3 ).
4 .1 .1
R ep o rtin g C o n ven tio n s
T ab les an d fig u res w ill b e su m m arized b y eith er treatm en t seq u en ce o r treatm en t g ro u p ,
as fu rth er d escrib ed in S ectio n 4 .4 an d S ectio n 4 .5 o f th e S A P . In g en eral, all d ata
co llected an d an y d eriv ed d ata w ill b e p resen ted in su b ject d ata listin g s, fo r all en ro lled
su b jects.L istin g s w ill b e o rd ered b y site,su b ject n u m b er,treatm en t seq u en ce,treatm en t
g ro u p , an d assessm en t o r ev en t d ate. T h e treatm en t seq u en ce p resen ted in listin g s w ill
b e b ased o n th e p lan n ed assig n m en t, u n less o th erw ise n o ted .
In g en eral, co n tin u o u s v ariab les w ill b e su m m arized to in d icate th e stu d y p o p u latio n
sam p le size (N ), n u m b er o f su b jects w ith av ailab le d ata (n ), m ean , stan d ard d ev iatio n
(S D ), m ed ian , first (Q 1 ) an d th ird (Q 3 ) q u artiles, m in im u m , an d m ax im u m
v alu es.
C ateg o rical v ariab les w ill b e su m m arized b y th e p o p u latio n size (N ), n u m b er o f
su b jects w ith av ailab le d ata (n ),n u m b er o f su b jects in each categ o ry ,an d th e p ercen tag e
o f su b jects in each categ o ry . U n less o th erw ise n o ted , th e d en o m in ato r to d eterm in e th e
p ercen tag e o f su b jects in each categ o ry w ill b e b ased o n th e n u m b er o f su b jects w ith
av ailab le d ata. S elect o rd in al d ata m ay b e su m m arized u sin g b o th d escrip tiv e statistics
an d co u n ts an d p ercen tag es o f su b jects in each categ o ry , as ap p ro p riate.
N o n -zero p ercen tag es w ill b e ro u n d ed to o n e d ecim al p lace. R o u n d in g co n v en tio n s fo r
p resen tatio n o f su m m ary statistics w ill b e b ased o n th e p recisio n o f th e v ariab le o f
su m m arizatio n , as it is co llected in its raw est fo rm
(i.e., o n th e eC R F o r as p ro v id ed
w ith in an ex tern al file) an d are o u tlin ed as fo llo w s:
•
T h e m ean an d m ed ian w ill b e ro u n d ed to o n e m o re d ecim al p lace th an th e
p recisio n o f th e v ariab le o f su m m arizatio n ;


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 1 6 o f 2 8
•
M easu res o f v ariab ility (e.g ., S D , stan d ard erro r [S E ]) w ill b e ro u n d ed to tw o
m o re d ecim al p laces th an th e p recisio n o f th e v ariab le o f su m m arizatio n ; an d
•
M in im u m an d m ax im u m v alu es w ill b e p resen ted u sin g th e sam e p recisio n as
th e v ariab le o f su m m arizatio n .
O th er statistics (e.g ., co n fid en ce in terv als [C Is]) w ill b e p resen ted u sin g th e sam e
g en eral ru les o u tlin ed ab o v e, o r assessed fo r th e m o st ap p ro p riate p resen tatio n b ased
o n th e u n d erly in g d ata.
U n less o th erw ise sp ecified , statistical sig n ifican ce testin g w ill b e tw o -sid ed an d
p erfo rm ed u sin g α = 0 .0 5 . P -v alu es w ill b e rep o rted fo r all statistical tests, ro u n d ed to
fo u r d ecim al p laces. P -v alu es less th an 0 .0 0 0 1 w ill b e d isp lay ed as “< 0 .0 0 0 1 .” P -v alu es
g reater th an 0 .9 9 9 9 w ill b e d isp lay ed as “> 0 .9 9 9 9 .” T ests o f in teractio n term s, if
ap p licab le, w ill b e tw o -sid ed an d p erfo rm ed u sin g α = 0 .1 0 .
4 .1 .2
S u m m a riza tio n b y V isit
D ata su m m arized b y stu d y v isit w ill b e b ased o n th e n o m in al, sch ed u led v isit lab el as
rep o rted o n th e eC R F fo r each treatm en t g ro u p . E ach treatm en t p erio d co n sists o f 4 2
d ay s an d stu d y v isits in T reatm en t P erio d 2 w ill b e lab eled acco rd in g to th e resp ectiv e
d ay w ith in th at treatm en t p erio d .F o r ex am p le,th e D ay 6 3 v isit o ccu rs d u rin g T reatm en t
P erio d 2 an d w ill b e lab eled as D ay 1 4 w ith in th at p erio d . D ata co llected fo r th e last
su b ject treatm en t v isit co m p leted w ith in each treatm en t p erio d w ill b e su m m arized
sep arately fo r:
•
T h e sch ed u led v isit fo r th o se su b jects w h o co m p lete th e sch ed u led en d o f
treatm en t v isit in each treatm en t p erio d p er p ro to co l. T h is w ill b e th e sch ed u led
D ay 4 2 fo r su b jects in T reatm en t P erio d 1 an d D ay 9 1 fo r su b jects in T reatm en t
P erio d 2 . T h is su m m ary w ill b e lab eled as “D ay 4 2 ” in th e an aly sis; an d
•
T h e last treatm en t v isit co m p leted o n -stu d y , co m b in in g d ata co llected fo r
su b jects w h o co m p lete th e sch ed u led en d o f treatm en t v isit, as w ell as th e v isit
d ata fo r th o se su b jects w h o d isco n tin u e th e stu d y early . T h is su m m ary w ill b e
lab eled as “D ay 4 2 /E T ” in th e an aly sis.
D ata co llected at u n sch ed u led v isits w ith in th e d o u b le-b lin d treatm en t p erio d w ill n o t
b e in clu d ed in b y -v isit su m m aries, b u t w ill b e co n sid ered w h en en d p o in t d eriv atio n s
p o ten tially in clu d e m u ltip le v isits (e.g ., d eterm in atio n o f b aselin e v alu e, d eterm in atio n
o f w o rst p o st-b aselin e v alu e, etc.). A ll d ata w ill b e in clu d ed in su b ject listin g s.
A n y su m m arizatio n o f d ata co llected d u rin g th e fo llo w -u p p erio d w ill b e p resen ted
sep arately an d w ill b e b ased o n th e n o m in al, sch ed u led v isit lab el as rep o rted o n th e
eC R F .
4 .1 .3
D a ta H a n d lin g R u les
U n less o th erw ise n o ted , v alu es rep o rted as g reater th an o r less th an so m e q u an tifiab le
lim it (e.g ., “< 1 .0 ”) w ill b e su m m arized w ith th e sig n su p p ressed in su m m ary tab les an d
fig u res, u sin g th e n u m eric v alu e rep o rted . D ata w ill d isp lay o n su b ject listin g s to
in clu d e th e sig n .


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 1 7 o f 2 8
4 .1 .4
S ta n d a rd C a lcu la tio n s
W h ere ap p ro p riate, th e calcu lated stu d y d ay o f each assessm en t o r ev en t w ill b e
p resen ted w ith th e assessm en t o r ev en t d ate o n su b ject d ata listin g s, w h ere stu d y d ay
w ill b e d eterm in ed as:
•
T h e
assessm en t/ev en t d ate
m in u s th e
d ate
o f first d o se
o f IP , if th e
assessm en t/ev en t d ate is p rio r to th e d ate o f first d o se; an d
•
T h e assessm en t/ev en t d ate m in u s th e d ate o f first d o se o f IP , p lu s o n e, if th e
assessm en t/ev en t d ate is o n o r after th e d ate o f first d o se.
U n less o th erw ise n o ted , stu d y d ay w ill b e calcu lated relativ e to th e d ate o f first d o se o f
IP .
O th er v ariab les req u irin g calcu latio n s w ill b e d eriv ed u sin g th e fo llo w in g fo rm u las:
•
D a y s: A d u ratio n b etw een tw o d ates ex p ressed in d ay s w ill b e calcu lated u sin g
th e fo llo w in g co n v en tio n s:
!
L ater d ate – earlier d ate + 1 , if th e earlier d ate is o n o r after th e d ate o f
first d o se o f IP ; o r
!
L ater d ate – earlier d ate, if th e earlier d ate is p rio r to th e d ate o f first
d o se o f IP .
•
M o n th s: A d u ratio n ex p ressed in m o n th s w ill b e calcu lated b y d iv id in g th e
d u ratio n in d ay s b y (3 6 5 .2 5 / 1 2 ).
•
Y ea rs: A d u ratio n ex p ressed in y ears w ill b e calcu lated b y d iv id in g th e d u ratio n
in d ay s b y 3 6 5 .2 5 .
•
C h a n g e fro m
B a selin e: C h an g e fro m
b aselin e w ill b e calcu lated as th e p o st
b aselin e v alu e m in u s th e b aselin e v alu e.
•
P ercen ta g e C h a n g e fro m
B a selin e: P ercen tag e ch an g e fro m b aselin e w ill b e
calcu lated as th e ch an g e fro m b aselin e d iv id ed b y th e b aselin e v alu e, m u ltip lied
b y 1 0 0 .
4 .2
A n a ly sis S ets
T h e an aly sis sets are d efin ed as fo llo w s:
•
E n ro lled A n aly sis S et (E N R ): T h e E N R co n sists o f all su b jects w h o m eet all
elig ib ility criteria an d co n sen t to p articip ate in th e stu d y . A ll listin g s w ill b e
b ased o n th e E N R u n less o th erw ise n o ted .
•
F u ll A n aly sis S et (F A S ): T h e F A S co n sists o f E N R su b jects w h o h av e at least
o n e v alid p o st-b aselin e efficacy ev alu atio n w ith in each treatm en t p erio d .
S u b jects w ill b e an aly zed
b ased
o n
th e treatm en t to
w h ich
th ey
w ere
ran d o m ized . S u b jects in th e F A S are referred to as ev alu ab le su b jects.


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 1 8 o f 2 8
•
S afety A n aly sis S et (S A F ): T h e S A F co n sists o f all su b jects w h o receiv e at least
o n e cap su le (1 0 0 m g ) o f IP . S u b jects w ill b e an aly zed b ased o n th e treatm en t
receiv ed .
•
P er P ro to co l A n aly sis S et (P P S ): T h e P P S in clu d es all su b jects in th e F A S w h o
h av e n o m ajo r p ro to co l v io latio n s. S u b jects w ill b e an aly zed b ased o n th e
treatm en t receiv ed .
D ata su m m aries to b e p resen ted o n th e S A F , F A S , an d P P S w ill o n ly b e p ro d u ced o n
all th ree an aly sis sets if th ere is a d ifferen ce in th e p o p u latio n g ro u p s.
4 .3
S tu d y S u b jects
4 .3 .1
D isp o sitio n o f S u b jects
S u b ject d isp o sitio n w ill b e su m m arized fo r th e S A F b y treatm en t seq u en ce an d o v er all
su b jects co m b in ed . S u m m aries w ill in clu d e th e n u m b er an d p ercen tag e o f su b jects in
each an aly sis set, co m p letin g th e stu d y , an d d isco n tin u in g th e stu d y early b y th e
p rim ary reaso n fo r d isco n tin u atio n .
4 .3 .2
P ro to co l D evia tio n s
M ajo r p ro to co l v io latio n s w ill b e su m m arized b y treatm en t g ro u p fo r th e F A S . M ajo r
p ro to co l v io latio n s are p ro to co l d ev iatio n s cap tu red o n -stu d y th at are d eem ed b y th e
S p o n so r to p o ten tially im p act th e efficacy o r safety co n clu sio n s o f th e stu d y .
A ll m ajo r p ro to co l v io latio n s w ill b e d eterm in ed an d ap p ro p riately categ o rized p rio r to
d atab ase lo ck an d p rio r to b reak in g th e b lin d o f th e treatm en t g ro u p assig n m en ts. T h e
n u m b er an d p ercen tag e o f su b jects w ith an y m ajo r p ro to co l v io latio n s as w ell as th e
n u m b er an d p ercen tag e o f su b jects w ith v io latio n s w ith in each categ o ry w ill b e
p resen ted .
4 .4
E ffica cy E v a lu a tio n
4 .4 .1
D a ta sets A n a lyzed
A ll efficacy su m m aries w ill b e b ased o n th e F A S ; select efficacy su m m aries w ill also
b e p ro d u ced o n th e P P S as a sen sitiv ity an aly sis. A d ata listin g o f su b jects ex clu d ed
fro m th e F A S o r P P S , to in clu d e th e reaso n fo r ex clu sio n , w ill b e p resen ted .
4 .4 .2
D em o g ra p h ic a n d O th er B a selin e C h a ra cteristics
D em o g rap h ic an d b aselin e ch aracteristic v ariab les w ill b e su m m arized b y treatm en t
seq u en ce an d o v er all su b jects co m b in ed fo r th e S A F , F A S , an d P P S .
D em o g rap h ic v ariab les in clu d e ag e, sex , eth n icity , an d race. A g e w ill b e rep o rted as
co llected o n th e eC R F an d su m m arized u sin g d escrip tiv e statistics. S ex , eth n icity , an d
race w ill b e su m m arized w ith th e n u m b er an d p ercen tag e o f su b jects in each p aram eter
categ o ry .


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 1 9 o f 2 8
B aselin e ch aracteristics in clu d e h eig h t, w eig h t, b o d y m ass in d ex (B M I), m ed ical
h isto ry , W A S I-II assessm en t, an d d o m ain /sy m p to m
o f g reatest im p airm en t. H eig h t,
w eig h t, B M I at b aselin e, an d W A S I-II assessm en t sco res w ill b e su m m arized u sin g
d escrip tiv e statistics. T h e d o m ain /sy m p to m o f g reatest im p airm en t w ill b e d eterm in ed
u sin g th e su b ject in clu sio n criteria d escrib ed in S ectio n 7 .1 o f th e clin ical stu d y p ro to co l
an d is fu rth er d escrib ed later in S ectio n 4 .4 .7 .8 .T h e n u m b er o f su b jects in each categ o ry
(an x iety sy m p to m s in clin ical ran g e, an x iety sy m p to m s in su b clin ical ran g e, A D H D
sy m p to m s in clin ical ran g e [m ajo rity related to in atten tio n ], A D H D
sy m p to m s in
su b clin ical ran g e [m ajo rity related to in atten tio n ], au tism sy m p to m s in clin ical ran g e,
an d au tism sy m p to m s in su b clin ical ran g e) w ill b e su m m arized w ith freq u en cy co u n ts
an d p ercen tag es.
M ed ical h isto ry co n d itio n s w ill b e m ap p ed to p referred term s an d sy stem o rg an classes
u sin g th e M ed ical D ictio n ary fo r R eg u lato ry A ctiv ities (M ed D R A , v ersio n 2 4 .1 ).
F req u en cy co u n ts an d p ercen tag es to su m m arize su b jects rep o rtin g ab n o rm al m ed ical
h isto ry b y sy stem o rg an class an d p referred term w ill b e p resen ted .
4 .4 .3
M ea su rem en ts o f T rea tm en t C o m p lia n ce
C o m p lian ce w ith th e stu d y treatm en t reg im en w ill b e d eterm in ed as th e to tal n u m b er
o f d o ses receiv ed d iv id ed b y th e ex p ected n u m b er o f d o ses receiv ed , m u ltip lied b y 1 0 0 .
T h e ex p ected n u m b er o f d o ses is d efin ed as th e d ate o f last d o se o f IP m in u s th e d ate
o f first d o se o f IP , p lu s o n e, tim es tw o . T h e to tal n u m b er o f d o ses receiv ed w ill b e
calcu lated as th e n u m b er o f ex p ected d o ses m in u s th e n u m b er o f m issed d o ses as
rep o rted o n th e S u b ject C h ecks eC R F . D o sin g co m p lian ce w ill b e su m m arized u sin g
d escrip tiv e statistics, b y treatm en t g ro u p , b ased o n th e S A F . T h e n u m b er an d
p ercen tag es o f su b jects w h o are < 8 0 %
co m p lian t an d ≥8 0 %
co m p lian t w ith in each
treatm en t g ro u p w ill b e su m m arized .
4 .4 .4
P rim a ry E ffica cy E n d p o in t A n a lysis M eth o d s
T h e p rim ary estim an d is th e d ifferen ce in m ean s b etw een treatm en t g ro u p s in th e C G I-
I scale p er cen tral rater fo r all su b jects in th e F A S . D ata co llected at p o st-b aselin e
ev alu atio n tim e p o in ts w ill b e co m b in ed acro ss th e tw o treatm en t p erio d s d ep en d in g o n
th e treatm en t receiv ed .
T h e n u ll h y p o th esis to b e tested is th at th ere is n o d ifferen ce b etw een P laceb o an d N B -
0 0 1 :
H 0: µ A = µ B ;
W h ere µ A an d µ B rep resen t th e m ean v alu es fo r P laceb o an d N B -0 0 1 , at th e en d o f each
resp ectiv e treatm en t p erio d . T h e altern ate h y p o th esis to b e tested is th at th e treatm en t
g ro u p m ean s d iffer:
H 1: µ A ≠µ B ;
T h e treatm en t effect w ill b e ev alu ated u sin g a m ix ed -effects m o d el th at in clu d es
treatm en t, v isit, treatm en t-b y -v isit in teractio n , p erio d , an d seq u en ce as fix ed effects,
su b ject n ested w ith in seq u en ce as a ran d o m effect, an d th e b aselin e C G I-S v alu e as a
co v ariate. T h e w ith in -su b ject erro rs w ill b e m o d eled u sin g an u n stru ctu red co v arian ce




N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 2 1 o f 2 8
4 .4 .7
S ta tistica l/A n a lytica l Issu es
4 .4 .7 .1 A d ju stm en ts fo r C o va ria tes
F o r all en d p o in ts w h ere b aselin e is co llected (i.e., all ex cep t th e im p ro v em en t scales),
th e m ix ed -effects m o d el to
co m p are treatm en t g ro u p s w ill in clu d e a co v ariate
ad ju stm en t fo r th e b aselin e v alu e.
4 .4 .7 .2 H a n d lin g o f D ro p o u ts o r M issin g D a ta
N o ex p licit im p u tatio n s w ill b e p erfo rm ed o n m issin g d ata; all an aly ses w ill b e b ased
o n o b serv ed d ata o n ly .
4 .4 .7 .3 In terim A n a lyses a n d D a ta M o n ito rin g
T h ere are n o in terim an aly ses p lan n ed , n o r is th ere a p lan to estab lish a d ata m o n ito rin g
co m m ittee fo r th is stu d y .
4 .4 .7 .4 M u lticen ter S tu d ies
E fficacy d ata co llected fro m all stu d y sites w ill b e p o o led fo r d ata an aly sis. T h e effect
o f stu d y site o n th e efficacy an aly sis resu lts m ay b e ex p lo red p o st h o c, as n eed ed .
4 .4 .7 .5 M u ltip le C o m p a riso n s/M u ltip licity
A n o v erall treatm en t effect ev alu atio n w ill b e p erfo rm ed u sin g th e g lo b al test fo r
m u ltip le en d p o in ts (O ’B rien 1 9 8 4 ; D m itrien k o an d T am h an e 2 0 0 9 ). T h is test relies o n
p o o lin g th e ev id en ce o f effectiv en ess acro ss sev eral en d p o in ts. T h e g lo b al altern ativ e
h y p o th esis to b e tested is th at N B -0 0 1 is u n ifo rm ly b etter th an p laceb o in th e m ean
ch an g es fro m
b aselin e in th e P A R S T o tal S ev erity S co re, A D H D -R S -5 In atten tio n
S u b scale S co re, an d S R S T M -2 T o tal D eriv ed T -S co re sco res w h en ev alu ated as a sin g le
in stru m en t.
T h e p ro ced u re w ill b e b ased o n th e o rd in ary least sq u ares (O L S ) estim ate o f th e
co m m o n effect size. In th is m eth o d , th e O L S test statistic w ill b e co m p u ted u sin g th e
fo llo w in g fo rm u la:
!" # $ =
!1 + !2 + ⋯+ !(
) 1 +
* 1 1 + ⋯
+ * 1 (
+ 1
w h ere +
= 3 is th e n u m b er o f en d p o in ts, !1 ,!2 ,… ,!( co rresp o n d to th e t-statistics
co m p u ted fo r each in d iv id u al en d p o in t sco re, an d * 1 1 ,… ,* 1 ( co rresp o n d to th e
P earso n co rrelatio n co efficien ts as d isp lay ed in th e co rrelatio n m atrix b elo w :
*, = -
1
⋯
* 1 (
⋮
⋱
⋮
* 1 (
⋯
1
0
T h e g lo b al o n e-sid ed p -v alu e co rresp o n d in g to th is test statistic w ill b e calcu lated u sin g
th e L o g an -T am h an e fo rm u la (L o g an an d T am h an e 2 0 0 4 ), an d w ill b e co n sid ered
sig n ifican t at th e 0 .0 2 5 lev el.


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 2 2 o f 2 8
T h e d ata w ill b e ch eck ed fo r n o rm ality an d a n o n p aram etric g lo b al testin g ap p ro ach
w ill b e ap p lied if m ajo r d ev iatio n s fro m n o rm ality are d etected .
4 .4 .7 .6 U se o f a n “ E ffica cy S u b set” o f S u b jects
T h e p rim ary efficacy an aly sis w ill b e p erfo rm ed o n th e F A S ; th e P P S w ill b e u tilized
as a sen sitiv ity an aly sis. T h e P P S w ill ex clu d e su b jects w ith m ajo r p ro to co l v io latio n s.
A su p p lem en tal sen sitiv ity an aly sis m ay also b e p erfo rm ed fo r su b jects w ith efficacy
assessm en ts p erfo rm ed o u t o f w in d o w fo r th e D ay 4 2 an d /o r D ay 9 1 stu d y v isits.
4 .4 .7 .7 A ctive-C o n tro l S tu d ies In ten d ed to S h o w E q u iva len ce
T h is stu d y d o es n o t in clu d e an activ e-co n tro l p ro d u ct an d is n o t in ten d ed to d em o n strate
eq u iv alen ce b etw een an y tw o d ru g p ro d u cts.
4 .4 .7 .8 E xa m in a tio n o f S u b g ro u p s
T h e efficacy an aly ses fo r P A R S T o tal S ev erity S co re p er cen tral rater, P A R S T o tal
S ev erity S co re p er lo cal rater, A D H S -R S -5 (In atten tio n an d H y p eractiv ity S u b scale
S co res), an d S R S T M -2 T o tal D eriv ed T -S co re w ill b e first ev alu ated w ith in th e su b set
o f su b jects w ith th e co rresp o n d in g sig n ifican t d o m ain /sy m p to m o f g reatest im p airm en t
(e.g ., th e treatm en t effect o n th e P A R S w ill b e assessed w ith in th e su b set w h ere th e
sy m p to m
o f g reatest im p airm en t is an x iety ). T h e d o m ain /sy m p to m
o f g reatest
im p airm en t w ill b e d eterm in ed at b aselin e u sin g th e p sy ch iatric sy m p to m s d escrib ed
b elo w (in clu sio n criteria # 3 in S ectio n 7 .1 o f th e clin ical stu d y p ro to co l):
a) P sy ch iatric sy m p to m s in th e clin ica l ran g e fo r at least o n e o f th ree d iso rd ers
(an x iety ,
atten tio n /ex ecu tiv e
d eficits,
an d
so cial
in teractio n /rep etitiv e
ten d en cies) as d em o n strated b y sco res at o r ab o v e th e fo llo w in g n u m b ers o n at
least 1 o f 3 scales:
!
P A R S 5 -Item S ev erity S co re ≥1 2
!
A D H D -R S -5 S co res o f 2 o r 3 o n at least 6 q u estio n s, w ith th e m ajo rity o f
sy m p to m s related to in atten tio n rath er th an h y p eractiv ity
!
S R S T M -2 D eriv ed T -S co re ≥6 0 ; o r
b ) P sy ch iatric sy m p to m s in th e su b clin ica l ran g e fo r at least tw o o f th ree scales:
!
P A R S 5 -Item S ev erity S co re o f 1 0 o r 1 1
!
A D H D -R S -5 S co res o f 2 o r 3 o n 4 o r 5 q u estio n s, w ith th e m ajo rity o f
sy m p to m s related to in atten tio n rath er th an h y p eractiv ity
!
S R S T M -2 D eriv ed T -S co re o f 5 5 -5 9 .
S u b jects m ay b e co u n ted in u p to th ree su b g ro u p s, co rresp o n d in g to an y clin ical o r
su b clin ical sy m p to m s th ey rep o rt fo r th e P A R S ,A D H D -R S -5 ,an d S R S T M -2 scales.T h e
six p o ssib le su b g ro u p s in w h ich a su b ject m ay b e co u n ted are listed b elo w :


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 2 3 o f 2 8
•
S u b jects w ith A n x iety S y m p to m s in th e C lin ical R an g e at E n ro llm en t
•
S u b jects w ith A n x iety S y m p to m s in th e S u b clin ical R an g e at E n ro llm en t
•
S u b jects w ith A D H D
S y m p to m s in th e C lin ical R an g e (M ajo rity R elated to
In atten tio n ) at E n ro llm en t
•
S u b jects w ith A D H D S y m p to m s in th e S u b clin ical R an g e (M ajo rity R elated to
In atten tio n ) at E n ro llm en t
•
S u b jects w ith A u tism S y m p to m s in th e C lin ical R an g e at E n ro llm en t
•
S u b jects w ith A u tism S y m p to m s in th e S u b clin ical R an g e at E n ro llm en t
F o r ex am p le, if a su b ject rep o rts sy m p to m s in th e clin ical ran g e fo r an x iety an d
sy m p to m s in th e su b clin ical ran g e fo r A D H D , th en th is su b ject w o u ld b e in clu d ed in
b o th th e S u b jects w ith A n x iety S y m p to m s in th e C lin ical R an g e at E n ro llm en t an d th e
S u b jects w ith A D H D S y m p to m s in th e S u b clin ical R an g e at E n ro llm en t su b g ro u p s.
In ad d itio n , th e an aly ses fo r th e C G I-I p er C en tral R ater an d th e C G I-S p er C en tral
R ater w ill b e rep eated fo r th ree su b g ro u p s o f th e F u ll A n aly sis S et:
•
S u b jects w ith A n x iety S y m p to m s at E n ro llm en t
•
S u b jects w ith A D H D S y m p to m s at E n ro llm en t
•
S u b jects w ith A u tism S y m p to m s at E n ro llm en t
F o r each o f th ese su b g ro u p s, all su b jects w ith an y sy m p to m s in th e clin ical o r
su b clin ical ran g e at en ro llm en t as d escrib ed ab o v e in in clu sio n criteria # 3 in S ectio n
7 .1 o f th e clin ical stu d y p ro to co l w ill b e in clu d ed in th e an aly sis.
A d d itio n al su b g ro u p an aly ses m ay b e p erfo rm ed p o st h o c, as ap p ro p riate.
4 .4 .8
P la sm a C o n cen tra tio n s
P lasm a co n cen tratio n m easu rem en ts w ill b e su m m arized in a sep arate rep o rt an d are
o u tsid e th e sco p e o f th is S A P .
4 .4 .9
P h a rm a co k in etic A n a lysis
P h arm aco k in etic an aly sis w ill b e su m m arized in a sep arate rep o rt an d is o u tsid e th e
sco p e o f th is S A P .
4 .5
S a fety E v a lu a tio n
S afety an aly sis w ill b e carried o u t fo r th e S A F , to in clu d e all su b jects w h o receiv e at
least o n e cap su le o f IP . S u b jects w h o d o n o t co m p lete b o th treatm en t p erio d s, fo r
w h atev er reaso n , w ill h av e all av ailab le d ata u p u n til th e tim e o f term in atio n in clu d ed
in th e an aly sis. F o r safety an aly sis p resen ted b y stu d y v isit, u n less o th erw ise stated , th e


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 2 4 o f 2 8
b aselin e v alu e w ill b e th e last m easu rem en t rep o rted p rio r to th e first d o se o f an y IP at
D ay 1 d u rin g T reatm en t P erio d 1 o r D ay 5 0 d u rin g T reatm en t P erio d 2 .
4 .5 .1
E x ten t o f E x p o su re
E x ten t o f ex p o su re to stu d y treatm en t w ill b e su m m arized fo r th e S A F b y treatm en t
g ro u p . T h e d u ratio n o f ex p o su re w ill b e p resen ted in d ay s an d calcu lated as th e d ate o f
last d o se o f IP m in u s th e d ate o f first d o se o f IP , p lu s o n e. D u ratio n o f ex p o su re an d
to tal d o se receiv ed (m g ) w ill b e su m m arized u sin g d escrip tiv e statistics.
4 .5 .2
A d verse E ven ts
T reatm en t-em erg en t A E s are d efin ed as th o se A E s w ith o n set after th e first d o se o f IP
o r ex istin g ev en ts th at w o rsen ed after th e first d o se d u rin g th e stu d y .
T reatm en t-em erg en t A E s w ill b e su m m arized b y treatm en t g ro u p th ro u g h th e en d o f
T reatm en t P erio d 2 . S elect T E A E su m m aries th ro u g h th e en d o f T reatm en t P erio d 2
w ill also b e p resen ted b y treatm en t p erio d . A n y A E s rep o rted d u rin g th e p o st treatm en t
F o llo w -u p p erio d w ill b e su m m arized sep arately b y treatm en t seq u en ce.
E ach T E A E w ill b e assig n ed to a sin g le treatm en t u sin g th e d ate an d tim e o f o n set. A
T E A E th at o ccu rs after th e first d o se o f IP in T reatm en t P erio d 1 b u t b efo re th e first
d o se o f th e IP in T reatm en t P erio d 2 w ill b e assig n ed to th e treatm en t asso ciated w ith
T reatm en t P erio d 1 . T h is in clu d es T E A E s th at m ay o ccu r in th e w ash o u t in terv al
b etw een treatm en t p erio d s.
A T E A E th at co n tin u es o v er b o th treatm en t p erio d s w ill b e co u n ted o n ly o n ce in th e
p erio d d u rin g w h ich th e ev en t started u n less th e T E A E w o rsen s in sev erity , in w h ich
case th e T E A E w ill b e attrib u ted to th e treatm en t p erio d d u rin g w h ich it p ro g ressed to
its m o st sev ere in ten sity . E v en ts rep o rted w ith a p artial o n set d ate (e.g ., m o n th an d y ear
are rep o rted b u t th e d ay is m issin g ) w ill b e co n sid ered to b e treatm en t-em erg en t if it
can n o t b e co n firm ed th at th e ev en t o n set w as p rio r to th e first d o se o f IP b ased o n th e
av ailab le d ate en tries.
V erb atim
term s o n case rep o rt fo rm s w ill b e m ap p ed to p referred term s an d sy stem
o rg an classes u sin g th e M ed ical D ictio n ary fo r R eg u lato ry A ctiv ities (M ed D R A ,
v ersio n 2 4 .1 ).
S u m m aries th at are d isp lay ed b y sy stem o rg an class an d p referred term s w ill b e o rd ered
b y d escen d in g in cid en ce o f sy stem o rg an class an d p referred term w ith in each sy stem
o rg an class. S u m m aries d isp lay ed b y p referred term o n ly w ill b e o rd ered b y d escen d in g
in cid en ce o f p referred term . S u m m aries o f th e fo llo w in g ty p es w ill b e p resen ted :
•
O v erall su m m ary o f n u m b er o f u n iq u e T E A E s an d treatm en t-em erg en t serio u s
ad v erse ev en ts (S A E s) an d su b ject in cid en ce o f T E A E s m eetin g v ario u s criteria;
•
S u b ject in cid en ce o f T E A E s b y M ed D R A
sy stem
o rg an class an d p referred
term ;
•
S u b ject in cid en ce o f th e m o st freq u en tly -o ccu rrin g T E A E s (i.e., T E A E s
o ccu rrin g in ≥1 0 % o f th e S A F ) b y M ed D R A p referred term ;


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 2 5 o f 2 8
•
S u b ject in cid en ce o f T E A E s b y C T C A E g rad e, M ed D R A sy stem o rg an class,
an d p referred term ;
•
S u b ject in cid en ce o f T E A E s b y relatio n sh ip to IP ,M ed D R A sy stem o rg an class,
an d p referred term ;
•
S u b ject in cid en ce o f th e m o st freq u en tly -o ccu rrin g T E A E s related to IP (i.e.,
related T E A E s o ccu rrin g in ≥1 0 % o f th e S A F ) b y M ed D R A p referred term ;
•
S u b ject in cid en ce o f ≥G rad e 3 T E A E s related to IP b y M ed D R A sy stem o rg an
class an d p referred term ;
•
S u b ject in cid en ce o f S A E s b y M ed D R A sy stem o rg an class an d p referred term ;
•
S u b ject in cid en ce o f serio u s T E A E s b y C T C A E g rad e, M ed D R A sy stem o rg an
class, an d p referred term ; an d
•
S u b ject in cid en ce o f serio u s T E A E s b y relatio n sh ip to IP , M ed D R A sy stem
o rg an class, an d p referred term .
In ad d itio n , su b ject in cid en ce o f T E A E s b y sy stem o rg an class an d p referred term w ill
b e su m m arized b y treatm en t seq u en ce fo r th e w ash o u t an d fo llo w -u p p erio d s.
A t each lev el o f su m m arizatio n (e.g ., an y A E , sy stem o rg an class, an d p referred term ),
su b jects ex p erien cin g m o re th an o n e T E A E w ill b e co u n ted o n ly o n ce. In th e su m m ary
o f T E A E s b y C T C A E g rad e, su b jects w ill b e co u n ted o n ce at th e h ig h est g rad e rep o rted
at each lev el o f su m m arizatio n ; in th e su m m ary o f T E A E s b y relatio n sh ip , su b jects w ill
b e co u n ted o n ce at th e clo sest relatio n sh ip to IP . A d v erse ev en t d ata w ill b e p resen ted
in d ata listin g s b y su b ject, treatm en t seq u en ce, treatm en t g ro u p , an d ev en t.
4 .5 .3
D ea th s, O th er S erio u s A d verse E ven ts, a n d O th er S ig n ifica n t A d verse E ven ts
A ll d eath s d u rin g th e stu d y , in clu d in g th e p o st treatm en t fo llo w -u p p erio d , w ill b e listed
b y su b ject, to in clu d e th e p rim ary cau se o f d eath . S erio u s A E s an d o th er sig n ifican t
A E s, in clu d in g th o se th at led to w ith d raw al, in terru p tio n , o r d o se red u ctio n o f th e IP ,
w ill b e p ro v id ed in sep arate su b ject d ata listin g s.
T reatm en t-em erg en t A E -S Is in th is trial w ill in clu d e th e d ev elo p m en t o f p sy ch o tic
sy m p to m s, S IB , seizu re, o v erd o se w ith u n to w ard m ed ical seq u alae, an d co n firm ed
cases o f C O V ID -1 9 , an d w ill b e p ro v id ed in a su b ject d ata listin g .
4 .5 .4
C lin ica l L a b o ra to ry E va lu a tio n
A ll d escrip tiv e su m m aries o f lab o rato ry resu lts w ill b e b ased o n d ata an aly zed b y th e
cen tral lab o rato ry an d p resen ted in S y stèm e In tern atio n al (S I) u n its, as su g g ested b y
th e C en ter fo r B io lo g ics E v alu atio n an d R esearch an d th e C en ter fo r D ru g E v alu atio n
an d R esearch P o sitio n o n U se o f S I U n its fo r L a b T ests (O ct 2 0 1 3 ). S u m m aries w ill
also b e p resen ted in co n v en tio n al u n its. A ll d ata w ill b e in clu d ed in b y -su b ject d ata
listin g s. L ab o rato ry m easu rem en ts id en tified as ab n o rm al (i.e., o u tsid e th e n o rm al
ran g e) w ill also b e listed sep arately b y su b ject, lab o rato ry test, an d u n it. In ad d itio n ,
n o rm al ran g es p ro v id ed b y th e cen tral lab o rato ry w ill b e p resen ted in a sep arate listin g .


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 2 6 o f 2 8
C lin ical lab o rato ry m easu rem en ts, in clu d in g seru m ch em istry an d h em ato lo g y , w ill b e
su m m arized b y treatm en t g ro u p . D escrip tiv e statistics w ill b e p resen ted fo r o b serv ed
v alu es an d ch an g es fro m b aselin e at each v isit w h ere p aram eters w ere sch ed u led to b e
co llected p er th e clin ical stu d y p ro to co l.
W h ere ap p licab le, lab o rato ry resu lts w ill b e classified as “lo w ,” “n o rm al,” o r “h ig h ”
w ith resp ect to th e p aram eter-sp ecific referen ce ran g es (i.e., b elo w th e lo w er lim it o f
th e n o rm al ran g e, w ith in th e n o rm al ran g e, o r ab o v e th e u p p er lim it o f th e n o rm al
ran g e). T h ree-b y -th ree co n tin g en cy tab les w ill b e p resen ted fo r each lab o rato ry
p aram eter to su m m arize th e sh ift fro m th e b aselin e categ o ry to th e w o rst p o st-b aselin e
m easu rem en t, d efin ed as th e v alu e n u m erically farth est o u tsid e o f th e n o rm al ran g e
acro ss all p o st-b aselin e v isits th ro u g h th e en d o f th e stu d y .
S u m m ary resu lts w ill in clu d e th e co u n t an d p ercen tag e o f su b jects w ith in each sh ift
categ o ry an d treatm en t g ro u p .
4 .5 .5
V ita l S ig n s, P h ysica l F in d in g s, a n d O th er O b serva tio n s R ela ted to S a fety
4 .5 .5 .1 V ita l S ig n s
V ital sig n
p aram eter m easu rem en ts
w ill b e
su m m arized
b y
treatm en t g ro u p .
D escrip tiv e statistics w ill b e p resen ted fo r resu lts an d ch an g e fro m b aselin e at each v isit
w h ere p aram eters w ere sch ed u led to b e co llected .
4 .5 .5 .2 1 2 -L ea d E lectro ca rd io g ra m
S elect tw elv e-L ead E C G in terv al p aram eters to in clu d e h eart rate, P R in terv al, Q R S
d u ratio n , an d co rrected Q T (Q T c) in terv al w ill b e su m m arized b y treatm en t g ro u p .
S u m m aries o f E C G s p erfo rm ed in trip licate w ill b e b ased o n th e m ean o f th e trip licate
m easu rem en ts at each tim e p o in t. F o r v isits w h ere th e in terp retatio n is p ro v id ed in
trip licate, th e w o rst in terp retatio n w ill b e u sed fo r an aly sis. D escrip tiv e statistics w ill
b e p resen ted fo r o b serv ed v alu es an d ch an g es fro m
b aselin e at each v isit w h ere
p aram eters w ere sch ed u led to b e co llected .
T w elv e-lead E C G s w ill b e classified b y th e in v estig ato r as “n o rm al,” “ab n o rm al, n o t
clin ically
sig n ifican t,”
o r
“ab n o rm al,
clin ically
sig n ifican t.”
T h ree-b y -th ree
co n tin g en cy tab les w ill b e p resen ted to su m m arize th e sh ift fro m th e b aselin e categ o ry
to th e w o rst p o st-b aselin e v alu e. S u m m ary resu lts w ill in clu d e th e co u n t an d p ercen tag e
o f su b jects w ith in each sh ift categ o ry an d treatm en t g ro u p .
4 .5 .5 .3 P h ysica l E xa m in a tio n
R esu lts o f th e p h y sical ex am in atio n w ill b e p resen ted in su b ject d ata listin g s b y su b ject,
stu d y v isit, an d b o d y sy stem .
4 .5 .5 .4 P rio r a n d C o n co m ita n t M ed ica tio n s
M ed icatio n s w ill b e co d ed u sin g th e W o rld H ealth O rg an izatio n D ru g D ictio n ary
E n h an ced (W H O D D E ), v ersio n S ep tem b er 1 , 2 0 2 1 . M ed icatio n s en tered o n th e eC R F
w ill b e m ap p ed to A n ato m ic T h erap eu tic C h em ical (A T C ) d ru g class (lev el 4 ) an d d ru g
n am e.


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 2 7 o f 2 8
P rio r an d co n co m itan t m ed icatio n s w ill b e su m m arized sep arately an d th e stu d y p h ase
o f each m ed icatio n w ill b e d eterm in ed p ro g ram m atically b ased o n m ed icatio n start an d
en d d ates. A p rio r m ed icatio n is d efin ed as an y m ed icatio n ad m in istered p rio r to th e
d ate o f th e first d o se o f IP in T reatm en t P erio d 1 . A co n co m itan t m ed icatio n is d efin ed
as an y m ed icatio n ad m in istered o n o r after th e d ate o f th e first d o se o f IP in T reatm en t
P erio d 1 . A m ed icatio n m ay b e d efin ed as b o th p rio r an d co n co m itan t. If it can n o t b e
d eterm in ed w h eth er a m ed icatio n w as receiv ed p rio r to th e start o f IP d o sin g d u e to
p artial o r m issin g m ed icatio n start an d /o r en d d ates, it w ill b e co n sid ered a p rio r
m ed icatio n . L ik ew ise, if it can n o t b e d eterm in ed w h eth er a m ed icatio n w as receiv ed
after th e start o f IP d o sin g , it w ill b e co n sid ered co n co m itan t. A n y m ed icatio n s
ad m in istered d u rin g th e p o st treatm en t fo llo w -u p p erio d w ill b e listed o n ly .
F o r b o th p rio r an d co n co m itan t m ed icatio n s su m m aries, th e n u m b er an d p ercen tag e o f
su b jects receiv in g an y m ed icatio n w ill b e su m m arized b y treatm en t g ro u p , as w ill th e
n u m b er an d p ercen tag e receiv in g an y m ed icatio n b y A T C d ru g class an d g en eric d ru g
n am e. P rio r m ed icatio n s w ill also b e su m m arized o v er all su b jects co m b in ed . S u b jects
rep o rtin g u se o f m o re th an o n e m ed icatio n at each lev el o f su m m arizatio n (an y
m ed icatio n receiv ed , A T C class, an d g en eric d ru g n am e) w ill b e co u n ted o n ly o n ce.
A T C class term s w ill b e d isp lay ed b y d escen d in g o rd er o f in cid en ce, as w ill g en eric
d ru g n am es w ith in each A T C class. T h e stu d y p h ase d u rin g w h ich each m ed icatio n w as
receiv ed (e.g ., p rio r, co n co m itan t, o r b o th ) w ill b e p resen ted o n th e listin g o f p rio r an d
co n co m itan t m ed icatio n s.
4 .6
D eterm in a tio n o f S a m p le S ize
A
to tal o f 3 0 ev alu ab le su b jects, w ith 1 5 su b jects in each treatm en t seq u en ce, are
p lan n ed
fo r en ro llm en t in
th is trial. T h e sam p le size is ch o sen
to
g u aran tee
ap p ro x im ately 8 0 % p o w er fo r d em o n stratin g a statistically sig n ifican t treatm en t effect
at a 2 -sid ed alp h a o f 0 .0 5 if th e tru e m ean d ifferen ce (N B -0 0 1 v ersu s p laceb o ) fo r th e
C G I-I sco re at th e en d o f each treatm en t p erio d is 1 an d th e stan d ard d ev iatio n is 1 .2 5 .
T h is sam p le size calcu latio n is b ased o n th e p aired t-test.
4 .7
C h a n g es in th e C o n d u ct o f th e S tu d y o r P la n n ed A n a ly ses
T h e p ro to co l d efin ed th e E N R as all su b jects w h o m eet all elig ib ility criteria an d receiv e
at least 1 co m p lete d aily d o se (4 0 0 m g ) o f IP . T h is d efin itio n w as restricted in th e S A P
to rem o v e th e “at least 1 co m p lete d aily d o se” req u irem en t. A ll su b jects w h o m eet
elig ib ility criteria an d co n sen t to stu d y p articip atio n w ill b e in clu d e in th is an aly sis set.
S ectio n 1 5 .4 o f th e p ro to co l states th at resp o n se rates w ill b e co m p ared b etw een
treatm en t g ro u p s u sin g F ish er’s ex act test. T h is test is n o t ap p ro p riate fo r th is cro ss-
o v er stu d y d esig n , an d th e M cN em ar’s test w ill b e u sed in stead .


N o b ias T h erap eu tics, In c.
S tatistical A n aly sis P lan
N B -0 0 1 -0 1
V ersio n 1 .0 ; 1 6 Ju n e 2 0 2 3
C o n fid en tia l
P ag e 2 8 o f 2 8
5 . R E F E R E N C E L IS T
A m erican
P sy ch iatric A sso ciatio n . D iag n o stic an d
statistical m an u al o f m en tal
d iso rd ers (5 th ed .). W ash in g to n , D C : P u b lish er. 2 0 1 3 .
B u sn er J, T arg u m S D . T h e clin ical g lo b al im p ressio n s scale: ap p ly in g a research to o l
in clin ical p ractice. P sy ch iatry (E d g m o n t). 2 0 0 7 ; 4 (7 ):2 8 -3 7 .
C o n stan tin o JN , D av is S A , T o d d R D , et al. V alid atio n o f a b rief q u an titativ e m easu re
o f au tistic traits: C o m p ariso n o f th e so cial resp o n siv en ess scale w ith th e au tism
d iag n o stic in terv iew rev ised . J. A u tism D ev . D iso rd . 2 0 0 3 ; 3 3 (4 ):4 2 7 -4 3 3 .
C o n stan tin o JN , G ru b er C P . S o cial resp o n siv en ess scale: M an u al. L o s A n g eles, C A :
W estern P sy ch o lo g ical S erv ices; 2 0 0 5 .
D m itrien k o A , T am h an e A C . A n aly sis o f m u ltip le en d p o in ts in clin ical trials. In
M u ltip le T estin g P ro b lem s in P h arm aceu tical S tatistics, D m itrien k o A , T am h an e A C ,
B retz F (ed ito rs). C h ap m an an d H all/C R C P ress: N ew Y o rk , 2 0 0 9 ; 1 3 1 -1 6 3 .
D u P au l G J, P o w er T J, A n asto p o u lo s, A D , et al. A D H D R atin g S cale-5 fo r ch ild ren an d
ad o lescen ts: C h eck lists, n o rm s, an d clin ical in terp retatio n . G u ilfo rd P ress. 2 0 1 6 .
F D A G u id an ce fo r In d u stry S u icid al Id eatio n an d B eh av io r: P ro sp ectiv e A ssessm en t o f
O ccu rren ce in C lin ical T rials. 2 0 1 2 .
G u y W . T h e C lin ical G lo b al Im p ressio n S cale. In : E C D E U A ssessm en t M an u al fo r
P sy ch o p h arm aco lo g y -R ev ised . R o ck v ille, M D : U S D ep t. o f H ealth , E d u catio n &
W elfare, A D A M H A , N IM H
P sy ch o p h arm aco lo g y R esearch B ran ch . 1 9 7 6 , p p 2 1 8 -
2 2 2 .
L o g an B R , T am h an e A C . O n O ’B rien ’s O L S an d G L S tests fo r m u ltip le en d p o in ts.
R ecen t D ev elo p m en ts in M u ltip le C o m p ariso n P ro ced u res. IM S L ectu re N o tes an d
M o n o g rap h S eries. B en jam in i Y , B retz F , S ark ar S . (ed ito rs). 2 0 0 4 , 7 6 -8 8 .
O ’B rien P C . P ro ced u res fo r co m p arin g sam p les w ith m u ltip le en d p o in ts. B io m etrics.
1 9 8 4 ; 4 0 :1 0 7 9 -1 0 8 7 .
R esearch U n its o n P ed iatric P sy ch o p h arm aco lo g y A n x iety S tu d y G ro u p . T h e P ed iatric
A n x iety R atin g S cale (P A R S ): D ev elo p m en t an d p sy ch o m etric p ro p erties. Jo u rn al o f
th e A m erican A cad em y o f C h ild & A d o lescen t P sy ch iatry . 2 0 0 2 ; 4 1 (9 ):1 0 6 1 – 1 0 6 9 .