Clinical trial NCT01626456: A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Official title: A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-22
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.


Eligibility criteria: Inclusion Criteria:

(Subjects who participated in ALK9072-003)

* Completed the ALK9072-003 Day 85 visit
* Continues to require treatment with an antipsychotic medication

(New Subjects)

* On a stable dose of oral antipsychotic medication
* Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable
* Has been able to achieve outpatient status for more than 3 months prior to screening
* Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
* Resides in a stable living situation

Exclusion Criteria:

(Subjects who participated in ALK9072-003)

* Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug
* Missed more than 1 scheduled study visit during participation in study ALK9072-003
* Has a significant or unstable medical condition that would preclude safe completion of the current study
* Subject is pregnant or breastfeeding
* Subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures

(New Subjects)

* History of poor or inadequate clinical response to treatment with aripiprazole
* History of treatment resistance
* Diagnosis of current substance dependence (including alcohol)
* Pregnant, lactating, or breastfeeding
* Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening
* Currently under involuntary hospitalization
* Current or expected incarceration

Additional inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
timeFrame: 52 weeks
Secondary outcomes:
measure: Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)
timeFrame: 52 weeks
measure: Discontinuation From Study Due to Adverse Events (AEs)
timeFrame: 52 weeks
measure: Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 52 weeks
measure: Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests
timeFrame: 52 weeks
measure: Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores
timeFrame: 52 weeks
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: 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: 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: 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: Targu Mures
country: Romania
facility: Alkermes Investigational Site
state: Mures
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: Oradea
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: Khotkovo
country: Russian Federation
facility: Alkermes Investigational Site
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: Talagi
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: Vinnytsia
country: Ukraine
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Alkermes Medical Director
role: STUDY_DIRECTOR
References:
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: McEvoy JP, Weiden PJ, Lysaker PH, Sun X, O'Sullivan AK. Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia. BMC Psychiatry. 2021 Mar 24;21(1):164. doi: 10.1186/s12888-021-03124-2.
citation: Lauriello J, Claxton A, Du Y, Weiden PJ. Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study. J Clin Psychiatry. 2020 Aug 18;81(5):19m12835. doi: 10.4088/JCP.19m12835.
citation: Nasrallah HA, Aquila R, Du Y, Stanford AD, Claxton A, Weiden PJ. Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia. CNS Spectr. 2019 Aug;24(4):395-403. doi: 10.1017/S1092852918001104. Epub 2018 Aug 15.
citation: Weiden PJ, Du Y, Liu CC, Stanford AD. Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period. CNS Spectr. 2019 Aug;24(4):419-425. doi: 10.1017/S1092852918000986. Epub 2018 Jun 26.