Phase 3
N=265
A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02873208 ↗Enrolled (actual)
265
Serious AEs
1.9%
Results posted
Jul 2021
Primary outcome: Primary: Number of Subjects With Adverse Events — 161; 93; 61; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ALKS 3831 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alkermes, Inc.
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events |
161; 93; 61; 7; 82; 79 | — |
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
- Agrees to use an acceptable method of contraception for the duration of the study
- Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days
- Additional criteria may apply
Exclusion Criteria
- Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
- 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 (NCT02873208). 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.