Phase 3
Completed N=523
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831
Schizophrenia · Schizophreniform Disorder · Bipolar I Disorder
Source: ClinicalTrials.gov NCT03201757 ↗
Enrolled (actual)
523
Serious AEs
6.7%
Results posted
Sep 2024
Primary outcomePrimary: Incidence of Adverse Events — 314 Participants
◆ Published Evidence
Emerging
6citations · ~3 / year
Long-Term Safety, Tolerability, and Durability of Treatment Effect of Olanzapine and Samidorphan: Results of a 4-Year Open-Label Study.
Summary
This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder
Linked Publications
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Long-Term Safety, Tolerability, and Durability of Treatment Effect of Olanzapine and Samidorphan: Results of a 4-Year Open-Label Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
314 | — |
| PRIMARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale |
-.24 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to give informed consent/assent as per local requirements
- Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal
- Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator
- Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307
- Additional criteria may apply
Exclusion Criteria
- Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements
- Has a positive drug screen for drugs of abuse at study entry
- Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
- Additional criteria may apply
Data sourced from ClinicalTrials.gov (NCT03201757) 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.