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Clinical trial

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

NCT07284745 is registered in ClinicalTrials.gov with Bristol-Myers Squibb as lead sponsor.

NCT NCT07284745
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
Lead sponsor
Bristol-Myers Squibb
Phase
Phase 3
Overall status
Not yet recruiting
Start date
September 11, 2026
Completion date
August 6, 2029
Enrollment
176 (estimated)
Sites
39

Conditions

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

irritability associated with autism spectrum disorder