Trials / Enrolling By Invitation
Enrolling By InvitationNCT04987229
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
Long-term, Safety Extension Study of OLZ/SAM in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
- Status
- Enrolling By Invitation
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 236 (estimated)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OLZ/SAM | Olanzapine and Samidorphan fixed dose coated tablet taken once daily |
Timeline
- Start date
- 2021-10-22
- Primary completion
- 2027-09-01
- Completion
- 2027-09-01
- First posted
- 2021-08-03
- Last updated
- 2026-02-18
Locations
36 sites across 5 countries: United States, Argentina, Brazil, Colombia, Mexico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04987229. Inclusion in this directory is not an endorsement.