Schizophrenia Clinical Trial
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
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.
Status | Completed |
Enrollment | 291 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Bulgaria | Alkermes Investigational Site | Burgas | |
Bulgaria | Alkermes Investigational Site | Novi Iskar | |
Bulgaria | Alkermes Investigational Site | Pazardzhik | |
Bulgaria | Alkermes Investigational Site | Plovdiv | |
Bulgaria | Alkermes Investigational Site | Sofia | |
Bulgaria | Alkermes Investigational Site | Targovishte | |
Bulgaria | Alkermes Investigational Site | Veliko Tarnovo | |
Bulgaria | Alkermes Investigational Site | Vratsa | |
Korea, Republic of | Alkermes Investigational Site | Jeollanam-do | |
Malaysia | Alkermes Investigational Site | Cheras | |
Malaysia | Alkermes Investigational Site | Johor Bahru | |
Malaysia | Alkermes Investigational Site | Kuala Lampur | |
Malaysia | Alkermes Investigational Site | Kuching | |
Philippines | Alkermes Investigational Site | Cebu City | |
Philippines | Alkermes Investigational Site | Iloilo City | |
Philippines | Alkermes Investigational Site | Mandaluyong City | |
Philippines | Alkermes Investigational Site | Manila | |
Philippines | Alkermes Investigational Site | Mariveles | Bataan |
Romania | Alkermes Investigational Site | Bucharest | |
Romania | Alkermes Investigational Site | Oradea | |
Romania | Alkermes Investigational Site | Targu Mures | |
Russian Federation | Alkermes Investigational Site | Lipetsk | |
Russian Federation | Alkermes Investigational Site | Moscow | |
Russian Federation | Alkermes Investigational Site | Roshchino | Vyborgskiy |
Russian Federation | Alkermes Investigational Site | Rostov-on-Don | |
Russian Federation | Roshchino township | Samara | |
Russian Federation | Roshchino township | Saratov | |
Russian Federation | Alkermes Investigational Site | St. Petersburg | |
Russian Federation | Alkermes Investigational Site | Stavropol | |
Russian Federation | Alkermes Investigational Site | Talagi | |
Russian Federation | Alkermes Investigational Site | Yaroslavl | |
Ukraine | Alkermes Investigational Site | Chernigiv | |
Ukraine | Alkermes Investigational Site | Donetsk | |
Ukraine | Alkermes Investigational Site | Kharkiv | |
Ukraine | Alkermes Investigational Site | Kherson | |
Ukraine | Alkermes Investigational Site | Kyiv | |
Ukraine | Alkermes Investigational Site | Lviv | |
Ukraine | Alkermes Investigational Site | Poltava | |
Ukraine | Alkermes Investigational Site | Ternopil | |
Ukraine | Roshchino township | Vinnytsia | |
United States | Alkermes Investigational Site | Atlanta | Georgia |
United States | Alkermes Investigational Site | Chicago | Illinois |
United States | Alkermes Investigational Site | Chicago | Illinois |
United States | Alkermes Investigational Site | Dallas | Texas |
United States | Alkermes Investigational Site | Dallas | Texas |
United States | Alkermes Investigational Site | Ft. Lauderdale | Florida |
United States | Alkermes Investigational Site | Garden Grove | California |
United States | Alkermes Investigational Site | Hoffman Estates | Illinois |
United States | Alkermes Investigational Site | Leesburg | Florida |
United States | Alkermes Investigational Site | Little Rock | Arkansas |
United States | Alkermes Investigational Site | Little Rock | Arkansas |
United States | Alkermes Investigational Site | Oakland | California |
United States | Alkermes Investigational Site | Oceanside | California |
United States | Alkermes Investigational Site | Oklahoma City | Oklahoma |
United States | Alkermes Investigational Site | Orange | California |
United States | Alkermes Investigational Site | Shreveport | Louisiana |
United States | Alkermes Investigational Site | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Alkermes, Inc. |
United States, Bulgaria, Korea, Republic of, Malaysia, Philippines, Romania, Russian Federation, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and percentage of subjects with treatment-emergent adverse events (TEAEs) | 12 months | No | |
Secondary | Change in baseline of Positive and Negative Syndrome Scale (PANSS) total score over time | 12 months | No | |
Secondary | Mean change from baseline to endpoint in Clinical Global Impression - Severity (CGI-S) over time | 12 months | No |
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