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)
Phase 3 – large-scale trial before approval
Conditions:
Mania or Mania with Mixed Features in Bipolar-I Disorder
Sponsor: Bristol-Myers Squibb Services Unlimited Company
trial.available_in:
БГ
Overview
Trial status: Authorised
To monitor for: serious side effects, specific side effects of concern, side effects that cause participants to stop treatment., To observe any changes in how participants respond to questions about suicidal thoughts or behaviors., To measure changes from the beginning of the study in: Movement and coordination (using tests like BARS, SAS, and AIMS); Urinary symptoms (for male participants aged 45 and older, using the IPSS questionnaire).
To track any side effects that participants experience while receiving the treatment.
Description
To monitor for: serious side effects, specific side effects of concern, side effects that cause participants to stop treatment., To observe any changes in how participants respond to questions about suicidal thoughts or behaviors., To measure changes from the beginning of the study in: Movement and coordination (using tests like BARS, SAS, and AIMS); Urinary symptoms (for male participants aged 45 and older, using the IPSS questionnaire).
Who can participate
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 148 participants
БГ