Last updated 31 days ago

A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

400 patients around the world

Available in Argentina, United States

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

400Patients around the world

This study is for people with

Schizophrenia

Autism Spectrum Disorder

To 17 Years

All Gender

: Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.

: Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.
Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.
Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.
Other protocol-defined Inclusion/Exclusion criteria apply.

SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Study typeInterventional

Conditions

SchizophreniaAutism Spectrum Disorder

Requirements

To 17 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07424404