Clinical trial NCT01469039: A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Alkermes
schizophrenia
ALKS 9072
ALKS 9070
aripiprazole lauroxil
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-10
Enrollment: 623
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-IV-TR criteria
* Has been able to achieve outpatient status for more than 3 months in the past year
* Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
* Resides in a stable living situation
* Willing and able to be confined to an inpatient study unit for 2 weeks or longer

Exclusion Criteria:

* History of poor or inadequate clinical response to treatment with aripiprazole
* History of treatment resistance
* Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
* Diagnosis of current substance dependence (including alcohol)
* Pregnant, lactating, or breastfeeding
* Receipt of any antipsychotic medication by IM injection within 60 days before Screening
* Current involuntary hospitalization or incarceration
* Hospitalized for more than 30 days during the 90 days before Screening

Additional inclusion/exclusion criteria may apply.

Primary outcomes:
measure: The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Data collected from baseline to day 85
Secondary outcomes:
measure: Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
timeFrame: 85 Days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Springdale
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Cerritos
country: United States
facility: Alkermes Investigational Site
state: California
city: Garden Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: La Habra
country: United States
facility: Alkermes Investigational Site
state: California
city: Oakland
country: United States
facility: Alkermes Investigational Site
state: California
city: Oceanside
country: United States
facility: Alkermes Investigational Site
state: California
city: Orange
country: United States
facility: Alkermes Investigational Site
state: California
city: San Diego
country: United States
facility: Alkermes Investigational Site
state: California
city: Washington
country: United States
facility: Alkermes Investigational Site
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Alkermes Investigational site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Hoffman Estates
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: Alkermes Investigational Site
state: Kansas
city: Rockville
country: United States
facility: Alkermes Investigational Site
state: Maryland
city: Creve Coeur
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Philadelphia
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Burgas
country: Bulgaria
facility: Alkermes Investigational Site
city: Kazanlak
country: Bulgaria
facility: Alkermes Investigational Site
city: Novi Iskar
country: Bulgaria
facility: Alkermes Investigational Site
city: Pazardzhik
country: Bulgaria
facility: Alkermes Investigational Site
city: Pleven
country: Bulgaria
facility: Alkermes Investigational Site
city: Plovdiv
country: Bulgaria
facility: Alkermes Investigational Site
city: Radnevo
country: Bulgaria
facility: Alkermes Investigational Site
city: Ruse
country: Bulgaria
facility: Alkermes Investigational Site
city: Sofia
country: Bulgaria
facility: Alkermes Investigational Site
city: Stara Zagora
country: Bulgaria
facility: Alkermes Investigational Site
city: Targovishte
country: Bulgaria
facility: Alkermes Investigational Site
city: Veliko Tarnovo
country: Bulgaria
facility: Alkermes Investigational Site
city: Vratsa
country: Bulgaria
facility: Alkermes Investigational Site
city: Jeju-si
country: Korea, Republic of
facility: Alkermes Investigational Site
city: Jeollanam-do
country: Korea, Republic of
facility: Alkermes Investigational Site
city: Seoul
country: Korea, Republic of
facility: Alkermes Investigational Site
city: Cheras
country: Malaysia
facility: Alkermes Investigational Site
city: Johor Bahru
country: Malaysia
facility: Alkermes Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Alkermes Investigational Site
city: Kuching
country: Malaysia
facility: Alkermes Investigational Site
city: Mariveles
country: Philippines
facility: Alkermes Investigational Site
state: Bataan
city: Cebu City
country: Philippines
facility: Alkermes Investigational Site
city: Iloilo City
country: Philippines
facility: Alkermes Investigational Site
city: Mandaluyong City
country: Philippines
facility: Alkermes Investigational Site
city: Manila
country: Philippines
facility: Alkermes Investigational Site
city: Pasig City
country: Philippines
facility: Alkermes Investigational Site
city: Oradea
country: Romania
facility: Alkermes Investigational Site
state: Bihor
city: Bucharest
country: Romania
facility: Alkermes Investigational Site
city: Bucharest
country: Romania
facility: Alkermes Investigational Site
city: Craiova
country: Romania
facility: Alkermes Investigational Site
city: Iasi
country: Romania
facility: Alkermes Investigational Site
city: Targu Mures
country: Romania
facility: Alkermes Investigational Site
city: Nikol'skoye
country: Russian Federation
facility: Alkermes Investigational Site
state: Gatchinckiy
city: Staritsa
country: Russian Federation
facility: Alkermes Investigational Site
state: Orenburg
city: Talagi
country: Russian Federation
facility: Alkermes Investigational Site
state: Primorsky
city: Khotkovo
country: Russian Federation
facility: Alkermes Investigational Site
state: Sergievo-Posadskiy
city: Lipetsk
country: Russian Federation
facility: Alkermes Investigational Site
city: Moscow
country: Russian Federation
facility: Alkermes Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Alkermes Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: Alkermes Investigational Site
city: Samara
country: Russian Federation
facility: Alkermes Investigational Site
city: Saratov
country: Russian Federation
facility: Alkermes Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Alkermes Investigational Site
city: Stavropol
country: Russian Federation
facility: Alkermes Investigational Site
city: Voronezh
country: Russian Federation
facility: Alkermes Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Alkermes Investigational Site
city: Stepanovka
country: Ukraine
facility: Alkermes Investigational Site
state: Kherson
city: Chernigiv
country: Ukraine
facility: Alkermes Investigational Site
city: Donetsk
country: Ukraine
facility: Alkermes Investigational Site
city: Kharkiv
country: Ukraine
facility: Alkermes Investigational Site
city: Kyiv
country: Ukraine
facility: Alkermes Investigational Site
city: Lugansk
country: Ukraine
facility: Alkermes Investigational Site
city: Lviv
country: Ukraine
facility: Alkermes Investigational Site
city: Poltava
country: Ukraine
facility: Alkermes Investigational Site
city: Simferopol
country: Ukraine
facility: Alkermes Investigational Site
city: Ternopil
country: Ukraine
facility: Alkermes Investigational Site
city: Uzhgorod
country: Ukraine
facility: Alkermes Investigational Site
city: Vinnytsya
country: Ukraine
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Alkermes Medical Director
role: STUDY_DIRECTOR
References:
citation: Targum SD, Risinger R, Du Y, Pendergrass JC, Jamal HH, Silverman BL. Effect of patient age on treatment response in a study of the acute exacerbation of psychosis in schizophrenia. Schizophr Res. 2017 Jan;179:64-69. doi: 10.1016/j.schres.2016.09.034. Epub 2016 Oct 1.
citation: Nasrallah HA, Newcomer JW, Risinger R, Du Y, Zummo J, Bose A, Stankovic S, Silverman BL, Ehrich EW. Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related Safety Considerations Among Patients With Acute Schizophrenia. J Clin Psychiatry. 2016 Nov;77(11):1519-1525. doi: 10.4088/JCP.15m10467.
citation: Citrome L, Du Y, Risinger R, Stankovic S, Claxton A, Zummo J, Bose A, Silverman BL, Ehrich EW. Effect of aripiprazole lauroxil on agitation and hostility in patients with schizophrenia. Int Clin Psychopharmacol. 2016 Mar;31(2):69-75. doi: 10.1097/YIC.0000000000000106.
citation: Meltzer HY, Risinger R, Nasrallah HA, Du Y, Zummo J, Corey L, Bose A, Stankovic S, Silverman BL, Ehrich EW. A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. J Clin Psychiatry. 2015 Aug;76(8):1085-90. doi: 10.4088/JCP.14m09741.
citation: Potkin SG, Risinger R, Du Y, Zummo J, Bose A, Silverman B, Stankovic S, Ehrich E. Efficacy and safety of aripiprazole lauroxil in schizophrenic patients presenting with severe psychotic symptoms during an acute exacerbation. Schizophr Res. 2017 Dec;190:115-120. doi: 10.1016/j.schres.2017.03.003. Epub 2017 Mar 23.
citation: Cameron C, Zummo J, Desai DN, Drake C, Hutton B, Kotb A, Weiden PJ. Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison. Value Health. 2017 Jul-Aug;20(7):876-885. doi: 10.1016/j.jval.2017.03.010. Epub 2017 May 9.
citation: Citrome L, Risinger R, Cutler AJ, Du Y, Zummo J, Nasrallah HA, Silverman BL. Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale-supportive analyses from a Phase 3 study. CNS Spectr. 2018 Aug;23(4):284-290. doi: 10.1017/S1092852917000396. Epub 2017 Jun 19.
citation: Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.
citation: Cameron C, Zummo J, Desai D, Drake C, Hutton B, Kotb A, Weiden PJ. Efficacy and safety of aripiprazole lauroxil once-monthly versus aripiprazole once-monthly long-acting injectable formulations in patients with acute symptoms of schizophrenia: an indirect comparison of two double-blind placebo-controlled studies. Curr Med Res Opin. 2018 Apr;34(4):725-733. doi: 10.1080/03007995.2017.1410471. Epub 2018 Jan 10.
citation: McEvoy JP, Risinger R, Mykhnyak S, Du Y, Liu CC, Stanford AD, Weiden PJ. Durability of Therapeutic Response With Long-Term Aripiprazole Lauroxil Treatment Following Successful Resolution of an Acute Episode of Schizophrenia. J Clin Psychiatry. 2017 Sep-Oct;78(8):1103-1109. doi: 10.4088/JCP.17m11625.