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Clinical trial

A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)

NCT06929273 is registered in ClinicalTrials.gov with Bristol-Myers Squibb as lead sponsor.

NCT NCT06929273
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)
Lead sponsor
Bristol-Myers Squibb
Phase
Phase 3
Overall status
Recruiting
Start date
July 18, 2025
Completion date
June 13, 2028
Enrollment
450 (estimated)
Sites
182

Conditions

As the registry lists them; a condition with its own page is linked.

bipolar disorder type i with mania