Trials / Completed
CompletedNCT01903837
A Study of ALKS 3831 in Adults With Schizophrenia
A Phase 2, Randomized, Multicenter, Safety, Tolerability, and Dose-Ranging Study of Samidorphan, a Component of ALKS 3831, in Adults With Schizophrenia Treated With Olanzapine
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 347 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Samidorphan (Low Dose) | Tablets taken once daily |
| DRUG | Samidorphan (Medium Dose) | Tablets taken once daily |
| DRUG | Samidorphan (High Dose) | Tablets taken once daily |
| DRUG | Placebo | Tablets taken once daily |
| DRUG | Olanzapine | Tablets taken once daily |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2014-12-01
- Completion
- 2015-03-01
- First posted
- 2013-07-19
- Last updated
- 2021-10-06
- Results posted
- 2021-09-08
Locations
61 sites across 3 countries: United States, Bulgaria, Czechia
Source: ClinicalTrials.gov record NCT01903837. Inclusion in this directory is not an endorsement.