Trials / Completed
CompletedNCT01895452
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 291 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALKS 9072, Low Dose | Intramuscular injection, given monthly |
| DRUG | ALKS 9072, High Dose | Intramuscular injection, given monthly |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2013-07-10
- Last updated
- 2017-08-25
- Results posted
- 2017-08-25
Locations
57 sites across 8 countries: United States, Bulgaria, Malaysia, Philippines, Romania, Russia, South Korea, Ukraine
Source: ClinicalTrials.gov record NCT01895452. Inclusion in this directory is not an endorsement.