Phase 3
N=277
A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02669758 ↗Enrolled (actual)
277
Serious AEs
2.9%
Results posted
Jul 2019
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 136 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ALKS 3831 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alkermes, Inc.
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
136 | — |
Summary
The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
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). 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.