# Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

> **NCT04987229** · PHASE3 · ENROLLING_BY_INVITATION · sponsor: **Alkermes, Inc.** · enrollment: 236 (estimated)

## Conditions studied

- Bipolar I Disorder
- Schizophrenia

## Interventions

- **DRUG:** OLZ/SAM

## Key facts

- **NCT ID:** NCT04987229
- **Lead sponsor:** Alkermes, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ENROLLING_BY_INVITATION
- **Start date:** 2021-10-22
- **Primary completion:** 2027-09
- **Final completion:** 2027-09
- **Target enrollment:** 236 (ESTIMATED)
- **Last updated:** 2026-05-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04987229

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04987229, "Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects". Retrieved via AI Analytics 2026-06-22 from https://api.ai-analytics.org/clinical/NCT04987229. Licensed CC0.

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