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Clinical trial

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)

NCT06951698 is registered in ClinicalTrials.gov with Bristol-Myers Squibb as lead sponsor.

NCT NCT06951698
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)
Lead sponsor
Bristol-Myers Squibb
Phase
Phase 3
Overall status
Recruiting
Start date
June 11, 2025
Completion date
November 1, 2026
Enrollment
274 (estimated)
Sites
74

Conditions

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

bipolar-i disorder with mania or mania with mixed features