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A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents

RecruitingPhase 3Ages 5 Years - 17 YearsAllKaruna Therapeutics, Inc., a Bristol Myers Squibb…
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 opinion of the investigator, may indicate an unacceptable safety risk. * De-novo participants must have confirmed diagnosis of ASD with symptoms of irritability, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL). 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, or ECG at the end of treatment visit of Study CN0120020, CN0120044 or CN00120045 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.
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What it tests

  • KarXT
  • KarX-EC
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Where

104 sites
Local Institution - 0054
Dothan, United States
Local Institution - 0163
Phoenix, United States
Advanced Research Center Inc.
Anaheim, United States
Local Institution - 0159
Anaheim, United States
Inland Psychiatric Medical Group.
Chino, United States
Proscience Research Group
Culver City, United States
Local Institution - 0162
Glendale, United States
Local Institution - 0153
Los Angeles, United States

…and 96 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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