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Clinical Trials in the EU / 2025-521845-26-00
Ongoing Phase III

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

2025-521845-26-00 · tracked via the Priya Life Science EU tracker
Sponsor
Bristol-Myers Squibb Services Unlimited Company
Sponsor type
Pharmaceutical company
Therapeutic area
Mental Disorders
Decision date
15/01/2026
Enrollment target
185
Sites
Romania, Poland, France, Italy, Denmark, Bulgaria

Condition studied

BP-I mania or mania with mixed features

Investigational medicinal product(s)

KarXTKarXTKarXT Matching PlaceboKarXTKarXT

Eligibility

Age group
18-64 years
Sex
Female, Male

Primary endpoint

Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 5.

Endpoint detail

Change from baseline in CGI-BP (used to evaluate daily functioning) at Week 5.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-521845-26-00 on CTIS ↗ ← All trials in the EU