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

Recruiting · NCT07424404 · Interventional (participants receive a specific treatment) · Lead sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

View the official record on ClinicalTrials.gov →

Schizophrenia

Interventions studied

KarXT

What this trial is about

The purpose of this study is 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

Who can take part

Age range

5 Years to 17 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

\- 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.

Exclusion criteria

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.

Where it is running

60 locations listed across 22 US states.

Local Institution - 0054 - Dothan, Alabama, United States
Local Institution - 0163 - Phoenix, Arizona, United States
Advanced Research Center Inc. - Anaheim, California, United States
Local Institution - 0159 - Anaheim, California, United States
Inland Psychiatric Medical Group. - Chino, California, United States
Proscience Research Group - Culver City, California, United States
Local Institution - 0162 - Glendale, California, United States
Local Institution - 0153 - Los Angeles, California, United States
Local Institution - 0158 - Orange, California, United States
Local Institution - 0174 - San Diego, California, United States
Local Institution - 0089 - San Francisco, California, United States
Local Institution - 0157 - San Rafael, California, United States
Local Institution - 0161 - Colorado Springs, Colorado, United States
Local Institution - 0154 - New Haven, Connecticut, United States
Local Institution - 0145 - Boca Raton, Florida, United States
Local Institution - 0160 - Gainesville, Florida, United States
Local Institution - 0164 - Gainesville, Florida, United States
Local Institution - 0168 - Hollywood, Florida, United States
Apg Research, Llc - Orlando, Florida, United States
Atlanta Center for Medical Research - Atlanta, Georgia, United States
Salveo Integrative Health - Lawrenceville - Lawrenceville, Georgia, United States
Denali Health Atlanta, LLC - Stone Mountain, Georgia, United States
Local Institution - 0175 - Chicago, Illinois, United States
EmVenio Research Center - Prime Healthcare - Chicago, Illinois, United States
Boston Children's Hospital - Boston, Massachusetts, United States
Local Institution - 0132 - Lexington, Massachusetts, United States
Local Institution - 0059 - Worcester, Massachusetts, United States
Local Institution - 0152 - Bloomfield Hills, Michigan, United States
Local Institution - 0142 - Columbia, Missouri, United States
Local Institution - 0147 - Lincoln, Nebraska, United States
Local Institution - 0144 - Las Vegas, Nevada, United States
Local Institution - 0146 - Neptune City, New Jersey, United States
Local Institution - 0061 - Great Neck, New York, United States
Local Institution - 0156 - Staten Island, New York, United States
Local Institution - 0151 - The Bronx, New York, United States
University of Cincinnati Cancer Institute - Cincinnati, Ohio, United States
Local Institution - 0148 - Cincinnati, Ohio, United States
Local Institution - 0139 - West Chester, Ohio, United States
Local Institution - 0143 - Danville, Pennsylvania, United States
Local Institution - 0150 - Pittsburgh, Pennsylvania, United States
Local Institution - 0137 - Nashville, Tennessee, United States
Local Institution - 0149 - Dallas, Texas, United States
VAST Clinical Research - Garland, Texas, United States
Local Institution - 0169 - Houston, Texas, United States
Local Institution - 0165 - Plano, Texas, United States
Local Institution - 0176 - Plano, Texas, United States
Local Institution - 0066 - Spring, Texas, United States
Local Institution - 0141 - Orem, Utah, United States
Local Institution - 0167 - West Point, Utah, United States
Local Institution - 0050 - Richmond, Virginia, United States
Local Institution - 0155 - Everett, Washington, United States
Local Institution - 0101 - Barcelona, Spain
Local Institution - 0099 - Barcelona, Spain
Local Institution - 0118 - Bordeaux, France
Local Institution - 0120 - Bron, France
Local Institution - 0040 - Bucharest, Romania
Cabinet Medical Individual Dr Gheorghita Karina Lidia - Bucharest, Romania
Local Institution - 0129 - Budapest, Hungary
Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry - Cluj-Napoca, Romania
Local Institution - 0121 - Gdansk, Poland

Showing 60 of 91 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →