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-2)
Phase 3 – large-scale trial before approval
Conditions:
BP-I mania or mania with mixed features
Sponsor: Bristol-Myers Squibb Services Unlimited Company
trial.available_in:
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Overview
Trial status: Authorised
Change from baseline in CGI-BP (used to evaluate daily functioning) at Week 3., Occurrence of TEAEs, SAEs, and TEAEs leading to treatment discontinuation and change in C-SSRS responses during the treatment period., Change from baseline in BARS, SAS, AIMS, and IPSS (males aged ≥ 45 years only) at Week 3.
Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 3.
Description
Change from baseline in CGI-BP (used to evaluate daily functioning) at Week 3., Occurrence of TEAEs, SAEs, and TEAEs leading to treatment discontinuation and change in C-SSRS responses during the treatment period., Change from baseline in BARS, SAS, AIMS, and IPSS (males aged ≥ 45 years only) at Week 3.
Who can participate
Age group: 18-64 years
Gender: Female, Male
Target enrollment: 89 participants
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