Phase 3
Completed N=265
A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Source: ClinicalTrials.gov NCT02873208 ↗Enrolled (actual)
265
Serious AEs
1.9%
Results posted
Jul 2021
Primary outcomePrimary: Number of Subjects With Adverse Events — 161; 93; 61; 7 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events |
161; 93; 61; 7; 82; 79 | — |
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. Informational only — not medical advice.