Clinical trial NCT01895452: An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Official title: A Phase 3, Multicenter Extension of Study ALK9072-003EXT 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
Keywords: Schizophrenia
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 291
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: This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.


Eligibility criteria: Inclusion Criteria:

* Completed the treatment period of Study ALK9072-003EXT
* Continues to require chronic treatment with an antipsychotic medication
* Continues to reside in a stable living situation
* Continues to have an identified reliable informant

Exclusion Criteria:

* Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug
* Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT
* 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, or has pending legal action which may impact compliance with study participation or procedures

Primary outcomes:
measure: Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time
timeFrame: Up to 12 months
measure: Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time
timeFrame: Up to 12 months
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: Garden Grove
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: Washington, D.C.
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: Shreveport
country: United States
facility: Alkermes Investigational Site
state: Louisiana
city: Oklahoma City
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
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: Novi Iskar
country: Bulgaria
facility: Alkermes Investigational Site
city: Pazardzhik
country: Bulgaria
facility: Alkermes Investigational Site
city: Plovdiv
country: Bulgaria
facility: Alkermes Investigational Site
city: Sofia
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: Jeollanam-do
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 Lampur
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: Bucharest
country: Romania
facility: Alkermes Investigational Site
city: Oradea
country: Romania
facility: Alkermes Investigational Site
city: Targu Mures
country: Romania
facility: Alkermes Investigational Site
city: Roshchino
country: Russian Federation
facility: Alkermes Investigational Site
state: Vyborgskiy
city: Lipetsk
country: Russian Federation
facility: Alkermes Investigational Site
city: Moscow
country: Russian Federation
facility: Alkermes Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: Alkermes Investigational Site
city: Samara
country: Russian Federation
facility: Roshchino township
city: Saratov
country: Russian Federation
facility: Roshchino township
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: Yaroslavl
country: Russian Federation
facility: Alkermes Investigational Site
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: Kherson
country: Ukraine
facility: Alkermes Investigational Site
city: Kyiv
country: Ukraine
facility: Alkermes Investigational Site
city: Lviv
country: Ukraine
facility: Alkermes Investigational Site
city: Poltava
country: Ukraine
facility: Alkermes Investigational Site
city: Ternopil
country: Ukraine
facility: Alkermes Investigational Site
city: Vinnytsia
country: Ukraine
facility: Roshchino township
Study officials:
affiliation: Alkermes, Inc.
name: Robert Risinger, MD
role: STUDY_DIRECTOR
References:
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.