Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients
Phase: PHASE4
Conditions: Hypothyroidism, Trisomy 21
Sponsor: Children's Mercy Hospital Kansas City

SHORT TITLE: 
Tirosint®-SOL T21 Study 
 
 
 
 
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PROTOCOL TITLE:  
Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients 
PRINCIPAL INVESTIGATOR: 
M. Max Feldt, DO 
Pediatric Endocrinology 
816-960-8803 
mmfeldt@cmh.edu 
 
VERSION NUMBER/DATE: 
10.0 22MAR2022 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
2 
19AUG2020 
Addition of AE/SAE Language 
No 
3 
23SEP2020 
Removing “vitals” from Summary of Events 
Table, this was an error 
Yes 
4 
12NOV2020 
Addition of Endocrine Clinic Intake Room and 
Outpatient Lab for Study Visits added. 
Addition of IRB approved recruitment flyers 
and Scope ad. 
Added recruitment at the Down Syndrome 
Clinic and associated Down Syndrome Support 
Group. 
Yes 
5 
29MAR2021 
Updated Sections 2.2, 11.0, and 12.0 to 
increase maximum age from less than 5 to less 
than 10 years. 
Updated Section 15.0 to increase study 
compensation to $50.00 per visit for a total of 
$150.00 for completion of all study visits. 
Corrected formatting in Section 28.00. 
Changed “Consent” to “Consent/Assent” in 
Summary of Events Table. 
Yes 
6 
17JUN2021 
Updated TOC to reflect correct page numbers, 
removed repetitive screening language, 
clarified that SOC visit labs must typically be 
within 6 weeks of baseline visit, clarified that 
head circumference should be obtained for 
Yes 

SHORT TITLE: 
Tirosint®-SOL T21 Study 
 
 
 
 
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participants less than 2 years old, added that 
drug can be shipped or given to participants at 
CMH location, Recruitment at DS clinic 
described more clearly, changed protocol 
version and date. Updated Schedule of Events 
to reflect correct study visit days. 
7 
29OCT2021 
Reformatted protocol to match latest CM 
Research IRB version, and updated TOC to 
reflect changes; replaced Summary of Events 
table with Table of Events; redefined study 
drug vs control, inclusion/exclusion criteria,  & 
identification/pre-screening/recruitment of 
participants; more clearly explained and 
defined study procedures, including blood 
collection, & study surveys; added clarification 
to consent/assent process and assessment of 
participant’s ability to assent; updated 
withdrawal of participants language to allow 
study staff to withdraw due to study conduct 
concerns; clarified AE/SAE monitoring and 
investigator’s responsibilities; clarified 
statistical analysis, data and specimen 
management, and study setting/location; 
various changes in grammar and word usage 
to make language and content consistent 
throughout the protocol 
Yes 
8 
12NOV2021 
Typo in exclusion criteria: ≥ changed to ≤ 
No 
9 
13JAN2022 
PQL survey moved in Schedule of Events table 
in protocol and ICF 
Yes 
10 
22MAR2022 
Remove PQL survey from visit 3 schedule of 
events.  Reworded primary objective and 
other parts of protocol to remove the word 
compliance and changed to ease of use.   
yes 
 
 
 

SHORT TITLE: 
Tirosint®-SOL T21 Study 
 
 
 
 
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Table of Contents 
STUDY INFORMATION 
1.0 Study Summary 
2.0 Objectives 
3.0 Background 
4.0 Study Endpoints 
5.0 Study Design 
6.0 Study Intervention/Investigational Agent 
PARTICIPANT MANAGEMENT 
7.0 Inclusion and Exclusion Criteria 
8.0 Local Number of Participants 
9.0 Screening and Recruitment Methods 
10.0 Procedures 
11.0 Surveys 
12.0 Sharing of Results with Participants 
13.0 Risks to Participants 
14.0 Potential Benefits 
15.0 Investigator Assessment of Risk/Benefits Ratio 
16.0 Payment, Reimbursement and Tangible Property Provided to Participants 
17.0 Economic Burden to Participants 
18.0 Permission/Assent/Consent Process 
19.0 HIPAA and Confidentiality 
20.0 Provisions to Protect the Privacy Interests of Participants 
21.0 Withdrawal of Participants 
DATA MANAGEMENT 
22.0 Data Collection 
23.0 Adverse Events and Unanticipated Problems 
24.0 Statistical Analysis 
25.0 Data and Specimen Management 
26.0 Settings and Locations 
 

SHORT TITLE: 
Tirosint®-SOL T21 Study 
 
 
 
 
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STUDY INFORMATION 
1.0 
Study Summary 
1.1 Synopsis 
 
Study Title 
Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric 
Patients 
Study Design 
Single-center, pilot, randomized, open-label crossover study 
Primary Objective 
Assessment of and tolerability ease of use of levothyroxine 
therapy based on CareCAT validation tool and medication 
administration log 
Secondary Objective(s) Compare biochemical effect of liquid stable LT4 versus 
tablet LT4 on TSH and FT4 in T21 hypothyroid patients 
Research 
Intervention(s)/ 
Investigational 
Agent(s) 
Tirosint®-SOL liquid stable levothyroxine 
IND/IDE# 
N/A 
Study Population 
Pediatric patients with Trisomy 21 and hypothyroidism 
Sample Size 
22  
Study Duration for 
Individual Participants 
Approximately 4 months 
Study Specific 
Abbreviations/ 
Definitions  
CH – congenital hypothyroidism 
CMH – Children’s Mercy Hospital 
FT4 – Free thyroxine 
GI – gastrointestinal 
LT4 – levothyroxine 
SOC – standard of care 
TSH – thyroid stimulating hormone 
T21 – Trisomy 21 
 
2.0 
Objectives 
2.1 
Purpose, specific aims, or objectives:  Hypothyroidism is a common 
medical disorder in children with Trisomy 21 (T21).  Treatment with oral tablet 
levothyroxine (LT4) is primarily used to treat this condition. However, children 
with T21 have developmental delay and other functional gastrointestinal (GI) 
issues that may negatively affect LT4 tolerability and absorption. For an age 
group unable to swallow tablets whole by mouth, tablets must be crushed and 
suspended in water, breast milk or formula for administration to treat children 
with hypothyroidism.  For this age group, ease of administration may have a 
significant impact on compliance and ability to remain euthyroid.  Until recently, 
there was no liquid preparation of LT4 in the United States for use in children. 

SHORT TITLE: 
Tirosint®-SOL T21 Study 
 
 
 
 
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Tirosint®-SOL (liquid stable LT4) is now FDA-approved for use in children. We 
propose that Tirosint®-SOL will be more favorably received due to ease of 
administration, improved tolerability, and palatability, therefore leading to 
improved adherence when compared to LT4 tablets. Our aims for this study are 
as follows: 
• Aim 1: Utilize medication tolerability questionnaire, CareCAT, to 
understand parental perceptions of liquid stable LT4 
• Aim 2: Evaluate differences in ease of use of liquid stable LT4 
compared to LT4 tablets 
• Aim 3: Compare biochemical effect of liquid stable LT4 versus 
table LT4 on TSH and FT4 in T21 hypothyroid patients 
2.2 
Hypothesis: We hypothesize that Tirosint®-SOL will be biochemically 
comparable to tablet LT4 as well as tolerated well and accepted by children with 
T21 and hypothyroidism ages 2 months to < 10 years.  Caregivers will perceive 
Tirosint®-SOL as a preferred dosage form. 
3.0 
Background 
3.1 
To date, there are no studies evaluating the response of liquid stable LT4 
in hypothyroid T21 children. 
3.2 
Trisomy 21 (T21) is one of the most common chromosomal disorders 
among live born infants. Its prevalence varies from 1 in 700 to 1 in 1500 live 
births. T21 is associated with many medical problems as well as developmental 
delay. Thyroid dysfunction is the most common endocrine abnormality and 
occurs in 4-8% of T21 children.  Hypothyroidism in T21 has a prevalence 
estimated to be 28-35 times higher than the general population.   Not all the 
mechanisms of hypothyroidism in T21 are known.  Autoimmune hypothyroidism 
is one common etiology as children with T21 have increased prevalence of 
autoimmunity.   Other possible etiologies include: 1. Exaggerated response to 
TRH stimulation in response to delayed maturation of hypothalamic – pituitary – 
thyroid axis; 2. Peripheral resistance to thyroid hormones (T4 and T3); 3. 
Reduced dopamine inhibition of TSH from altered dopaminergic regulation; and 
4. Reduced TSH bioactivity.  Due to these complex interactions, the use of 
traditional oral LT4 can lead to persistent elevation of TSH in 20-50% of 
hypothyroid T21 patients. The use of adjunctive liothyronine (L-T3) has been 
used to help normalize TSH but at the expense of complicating medication 
therapy.   Recently, a liquid stable formulation of LT4 has been FDA approved for 
children in the United States. This form has been approved, extensively studied, 
and utilized in Europe for many years. Tirosint®-SOL is packaged in mono-dose 
ampules in 12 different dosage strengths. Tirosint®-SOL may be administered 
either directly into the mouth or a spoon or diluted in a glass of water. This novel 
form of LT4 has advantages in pharmacokinetic profile compared to traditional 
tablet LT4 due to direct intestinal absorption without a dissolution phase.  

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Tirosint®-SOL T21 Study 
 
 
 
 
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Traditional LT4 exists as a sodium salt that requires optimal acidic environment 
for dissolution and is susceptible to drug interference with calcium and iron 
supplements, estrogen, and other medications. On average approximately three 
quarters of the tablet LT4 is effectively absorbed.  In contrast, multiple studies 
have demonstrated liquid stable LT4 is less affected by concomitant medication 
and supplement administration, offers improved biochemical levels of TSH, FT4 
and FT3, and improved treatment compliance. 
4.0 
Study Endpoints 
4.1 
Primary endpoint: Parent perception responses from CareCAT medication 
tolerability tool 
4.2 
Secondary endpoint: TSH and FT4 drawn 8-weeks post intervention 
4.3 
Tertiary endpoint: linear growth (height), weight gain, and head 
circumference growth 
5.0 
Study Design 
5.1 
Study Design: This is a single-center, pilot, randomized, open-label, cross-
over study to determine satisfaction of standard LT4 tablets compared to liquid 
stable LT4 (Tirosint® -SOL) therapy and biochemical comparability in 22 
participants diagnosed with Trisomy 21 and congenital or acquired 
hypothyroidism already on levothyroxine (LT4). Participants will be randomized 
in a 1:1 ratio to treatment (Tirosint®-SOL) or control (conventional therapy with 
LT4 tablets) for 8 weeks, at which point they will then crossover to receive the 
treatment arm they were not initially randomized to receive.   
Participants will continue their same daily dose of LT4 or Tirosint®-SOL within the 
randomly assigned treatment group. Dose adjustments are allowed as needed, 
based on laboratory results and clinical response. Once enrolled, participants will 
be treated for 16 weeks total. The study will involve up to 3 in-person visits and 2 
safety phone calls. Enrollment visit may be done via approved CMH video 
conferencing platform.    
 
 
 
 
 
 
 
 
 

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5.2 
Table of Events:  
Procedures 
Enrollment/Baselinea 
Visit 1 
Dosing Week 1b 
Days 1-7 
Study Visit 2c 
Day 3 +/-1 day 
Dosing Weeks 2-8 
Days 8-56 
Study Visit 3, Week 8 
Day 56 +/- 4 days 
Dosing Week 9b 
Days 63-70 
Study Visit 4c 
Day 65 +/-1 1 day 
Dosing Weeks 10-16 
Dyas 71-112 
Study Visit 5 
Day 112 +/- 4 days 
Obtain permission/assent or consent 
X 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
 
 
 
Dispense study intervention 
X 
 
 
 
X 
 
 
 
 
Concomitant medication review 
X 
 
X 
 
X 
 
X 
 
X 
Head Circumference 
X 
 
 
 
X 
 
 
 
X 
Height 
X 
 
 
 
X 
 
 
 
X 
Weight 
X 
 
 
 
X 
 
 
 
X 
Labs (TSH & FT4) 
X 
 
 
 
X 
 
 
 
X 
Adverse event review  
 
 
X 
 
X 
 
X 
 
X 
CareCAT Surveyd 
 
X 
 
 
 
X 
 
 
 
Dosing Videoe 
 
X 
 
 
 
X 
 
 
 
PQL Survey 
X 
 
 
 
X 
 
 
 
 
Medication Administration Log 
 
X 
 
X 
 
X 
 
X 
 
a: Head circumference, height, and weight and labs from enrollment/baseline visit will be collected from Standard of Care visit within the 
previous 6 weeks 
b: Day 1 and Day 9 will be the first day of study drug administration in each arm 
c: Study Visit 2 and Study Visit 4 will be phone calls 
d: CareCAT survey will be done once daily during Week 1 and Week 9 
e: Dosing videos to be done within first 5 days of dosing in each arm 
 
6.0 
Study Intervention/Investigational Agent 
6.1 
Description: Tirosint®-SOL (levothyroxine sodium) is a ready-to-use clear, 
colorless to slightly yellow oral solution containing LT4. It is supplied in 1 mL 
white single-dose ampules. Inactive ingredients are glycerol and water. IBSA 
Pharma Inc. will provide Tirosint®-SOL for the study at the following strengths 
(mcg/mL): 13, 25, 38, 50. Commercially available LT4 tablets will also be used in 
the study. Inactive ingredients vary between formulations. LT4 tablets for the 
study will be supplied in the following strengths (mcg): 25, 50, 75.  Children’s 
Mercy IDS Pharmacy will store, handle, and dispense the study drug per 
Research Pharmacy SOP for the Control of Investigational Drugs. 
6.2 
Drugs or Biologics:  
Drug/Biologic Name 
FDA Approval Status and Use in this Study 
 Tirosint®-SOL 
 FDA approved, and being used within FDA labeling 
 Levothyroxine sodium 
 FDA approved, and being used within FDA labeling 

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PARTICIPANT MANAGEMENT 
7.0 
Inclusion and Exclusion Criteria 
7.1 
Eligibility Criteria:  
Inclusion Criteria 
• Participant is at least 2 months old and less than 10 years of age  
• Prior confirmed diagnosis of Trisomy 21 
• Prior confirmed diagnosis of congenital or acquired hypothyroidism 
• Currently takes levothyroxine sodium by mouth 
• Gestational age >35 week 
Exclusion Criteria 
• Gestational age ≤35 weeks 
• Participant currently takes anticonvulsant medication 
• Participant takes medication through G-tube or another parenteral route 
• Participant has more than 2 missed SOC clinic visits in the last 2 years 
• Participant has documented history of noncompliance with levothyroxine 
• Participant is currently in foster care or state custody 
 
7.2 
Vulnerable Populations: Check any vulnerable populations that are being 
targeted for enrollment into the study: (Members of the following populations 
may not be included as participants in the research unless selected here.) 
☒ Children/Minors (under 7 years of age) 
☒ Children/Minors (7-17 years of age) 
☐ Neonates (infants less than 30 days old) 
☐ Neonates of Uncertain Viability (infants 
less than 30 days old) 
☐ Non-Viable Neonates (infants less than 
30 days old) 
☐ Wards of the State 
☐ Fetuses 
☐ Pregnant Women  
☐ Adults with impaired decision-making 
capacity         
☐ CM Employees 
☐ CM Students/Residents/ Fellows 
☐ Economically or Educationally 
Disadvantaged Persons 
☐ Prisoners 
 
 

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Tirosint®-SOL T21 Study 
 
 
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• We will enroll children between the ages of 2 months and < 10 years, therefore 
meeting the definition of children as a vulnerable population. Participants may 
also have developmental delays. Study rationale, procedures, risks, and benefits 
will be explained prior to enrollment by one of the study team members using 
plain English with minimal medical terminology. The research staff will ensure 
that the potential participant’s parent(s)/LAR understand that participation is 
voluntary. Parent/LAR will be assured that their child’s research records will be 
kept confidential and will only be available to study personnel. To minimize 
coercion, parent(s)/LAR will be reassured that participation in no way influences 
or impacts their child’s medical treatment.  This research does not include other 
vulnerable populations including neonates, pregnant women, prisoners, or 
cognitively impaired adults. It is possible that a CMH employee’s child may be 
eligible for this study.  In this event, they will be allowed to participate.  The 
employee will be reassured that participation is voluntary.  If the research 
involves enrolling CM employees or students, indicate how the potential for 
employees/students to feel coerced or unduly influenced to participate will be 
minimized. For example, the risk of coercion may be minimized by ensuring that 
employees will not be recruited or enrolled by their direct supervisor. 
 
8.0 
Local Number of Participants 
8.1 
A total of 22 subjects will be enrolled in this study. Study participation 
will last approximately 4 months. 
 
9.0 
Identification and Recruitment of Potential Participants 
9.1 
Identification of Potential Participants: Patients may be identified from 
the CMH Endocrine Clinic outpatient visit schedule, by a list of potential eligible 
patients through a batch medical chart review from IT, individual chart review, or 
through outside referrals. Research staff may approach parent(s)/LAR of eligible 
patients during Endocrine Clinic visits, by phone, or by email.  Patients may also 
be referred by Downs Syndrome Clinic providers. Baseline visit may occur in 
Downs Syndrome Clinic with approval of Down Syndrome Clinic Medical 
Director. Potential participants may also self-refer in response to posted 
advertisements. Study team members may contact potential participants no 
more than three times to determine interest in this study.  Contact attempts and 
refusals will be documented in the pre-screening log. Refusals will not be 
approached further. 
9.2 
Pre-Screening prior to HIPAA Authorization: In accordance with 
45 CFR 164.512(i)(1)(ii), qualified participants will be identified and 
recorded initially by creation of a pre-screening log.  The pre-screening 
log will be maintained to aid in participant identification and eligibility 
status. This will aid key study personnel in efficiently and effectively 
attending clinic visits for optimal recruitment.  PHI may be collected and 
stored in pre-screening log and may contain, names (participant and 

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Tirosint®-SOL T21 Study 
 
 
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parents/LAR), address, phone number, email address, medical record 
number, date of birth, age, clinic visit date, clinic location, clinic provider 
& appointment time, diagnoses, as well as coordinator/investigator notes 
regarding eligibility/scheduling. A Waiver of HIPAA is being requested for 
recruitment purposes only. Data from subjects who are determined 
ineligible or chose not to participate will be kept until the completion of 
enrollment to avoid approaching them multiple times.  When enrollment 
is complete, this data will be deleted for patients that did not enroll. 
9.3 
Recruitment of Potential Participants: IRB-approved recruitment 
flyers may be distributed at the CMH Endocrine and Down Syndrome 
Clinics and the Down Syndrome Guild of Greater Kansas City. The study 
may also be advertised using the recruitment flyer in the employee 
announcement bulletin board (Scope), internal employer website, or 
email.  
10.0 Procedures 
11.0 Surveys: 
12.0 Sharing of Results with Participants 
12.1 
Results of study labs will be provided to parents of subjects.  No other 
study data will be shared with subjects 
13.0 Risks to Participants 
13.1 
The risk for Levothyroxine and Tirosint®-SOL are the same and may 
include shortness of breath, irregular heart rate, heart attack, muscle spasms, 
headache, nervousness, irritability, insomnia, tremors, muscle weakness, 
increased appetite, weight loss, diarrhea, heat intolerance, and skins rash.  It is 
possible to have an allergic reaction to the other additional components included 
in either study drug. Allergic reactions usually happen right away after taking the 
medicine by mouth and symptoms include having a rash. These reactions are 
very rare. Participants will be on levothyroxine regardless of study participation, 
so there is no increased risk with study participation 

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13.2 
The researchers believe the risks involved in this study are not greater 
than minimal risk 
14.0 Potential Benefits 
14.1 
Patients may benefit from improved tolerability of administration of the 
study drug. Subject may have improved biochemical response and absorption to 
medication, evaluated by TSH & LT4 lab results. 
16.0 Payment, Reimbursement and Tangible Property provided to 
participants 
17.0 Economic Burden to Participants 
18.0 Permission/Assent/Consent Process 
18.1 
Indicate below all methods of Permission/Consent that will be used in 
this study: 
18.2 
Assessment of Ability to Assent: Study staff will ask parent(s)/LAR if their 
child has been diagnosed with any developmental or cognitive delay. If yes, 
study staff will ask if parent(s)/LAR feel the participant is at or above the 
cognitive and development level of an average 7-year-old. Any child 7 years and 
older and at a cognitive or developmental level typical of an average 7-year-old 
will be assented. Study staff reserve the right to withhold assent on any 
participant deemed ineligible due to cognitive or development level based solely 
on the assessment of the study staff. Assessment of ability to assent will be 
documented in consent note per CMH research policy.  
18.3 
Permission/Assent/Consent Discussion: Consent and assent discussion 
may take place in one of the CMH Endocrine Clinic locations, by phone, or 
approved CMH video conferencing platform per CMH research policy. Consent 
discussions conducted in person will be held in a private room. Consent and 
assent will be presented by designated study staff to parent(s)/LAR. 
Parent(s)/LAR and participants will be reminded that research is voluntary and 
will be provided ample time to read, review, and ask questions about 
participating in the research study. Parent(s)/LAR and participant will be 
provided and allowed the opportunity to meet with the PI privately to discuss 
consent if requested. Parent(s)/LAR and participant will be provided a copy of 
the consent to take home to allow for more time if needed. Person giving 
consent and assent will utilize teach back to confirm understanding prior to 

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signing of consent and assent. Parental consent and participant assent will be 
verbally confirmed prior to performing study procedures at every visit. 
19.0 HIPAA and Confidentiality 
19.1 
Full Written HIPAA Authorization will be obtained withing the 
permission/consent from. A Partial Waiver of HIPAA Authorization for 
Recruitment Only will be requested as described in section 9.2. 
19.2 
Research staff will emphasize that participate in research is voluntary and 
that participants may withdraw at any time without penalty. Verbal permission 
to continue participation in study will be obtained at the beginning of every 
study visit. All procedures will be explained with an opportunity for 
parent(s)/LAR to ask questions prior to proceeding with study procedures 
20.0 Provisions to Protect the Privacy Interests of Participants 
21.0 Withdrawal of Participants 
21.1 
Participants may be withdrawn by study staff at any time for an issue 
with study compliance, any concerns of harm to the participant, or if study labs 
reveal that the participant no longer needs levothyroxine (at the discretion of 
the PI). Participants may also be withdrawn if the study staff or CMH Research 
Compliance discover any issues that could compromise the safety of the 
participants or the integrity of the study data. Any participant withdrawals will 
be discussed with the PI and documented by the study coordinator in a research 
note in the electronic medical record. 
21.2 
All data collected prior to participant withdrawal will be retained by the 
study. Participants will be asked to return all study medication, both unused and 
empty packaging to the study coordinator to be returned to IDS Pharmacy for 
drug accountability. Participants will be instructed to continue their regular care 
with their Endocrine provider 
22.0 Data Collection 
23.0 Adverse Events and Unanticipated Problems 
23.1 
Monitoring: Parent(s)/LAR of participants will be asked at every study 
visit if there have been any changes to the participant’s health status since the 
last contact. Any change in medical history after enrollment visit will be 
considered an AE and will be documented. Any open AE/SAE at the end of study 
will only be followed if the PI has determined it is related to study participation. 

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Open AE/SAEs attributed to study participation will be followed until resolved or 
the discretion of the PI. 
24.0 Statistical Analysis 
25.0 Data and Specimen Management 
26.0 Setting & Location 
26.1 
This study will be conducted at any of the CMH Endocrine Clinics or 
virtually through a CMH approved video conferencing platform. No community 
advisory boards will be involved in the research study. No study procedures will 
be conducted outside of the CMH organization. Participants will be given contact 
information for both the PI and lead Nurse Coordinator.  If laboratory results 
reflect a need in dose change, the child’s provider will be consulted for that 
decision.  No other anticipated medical or psychological resources are 
anticipated.