Clinical trial
A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
NCT07140913 is registered in ClinicalTrials.gov with Bristol-Myers Squibb as lead sponsor.
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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 Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
- Lead sponsor
- Bristol-Myers Squibb
- Phase
- Phase 3
- Overall status
- Recruiting
- Start date
- October 8, 2025
- Completion date
- June 28, 2027
- Enrollment
- 424 (estimated)
- Sites
- 104
Conditions
As the registry lists them; a condition with its own page is linked.