Phase 3
Completed N=277
A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Source: ClinicalTrials.gov NCT02669758 ↗Enrolled (actual)
277
Serious AEs
2.9%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 136 Participants
◆ Published Evidence
Emerging
1citation · ~1 / year
The Efficacy of Olanzapine/Samidorphan on Negative Symptoms: A Post Hoc Analysis of 56-Week Treatment in Patients With Schizophrenia.
Summary
The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
Linked Publications
-
The Efficacy of Olanzapine/Samidorphan on Negative Symptoms: A Post Hoc Analysis of 56-Week Treatment in Patients With Schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
136 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has completed the 4-week treatment period (all visits up to and including end of treatment visit) in the antecedent study ALK3831-A305 within 7 days.
- Agrees to use an acceptable method of contraception for the duration of the study.
- Additional criteria may apply.
Exclusion Criteria
- Subject is currently taking medications that are contraindicated with olanzapine use.
- Subject has a positive test for drugs of abuse at study entry.
- Subject is pregnant, planning to become pregnant, or breastfeeding during the study.
- Additional criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02669758) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.