Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing KarXT for Schizophrenia

This study wants to measure the long-term whether it is safe and how hard side effects are to live with of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents

Official registry: https://clinicaltrials.gov/study/NCT07424404 · Karuna Therapeutics, Inc., a Bristol Myers Squibb company · enrollment listed as 400

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are KarXT, or KarX-EC. The registry lists allocation as randomized. This study wants to measure the long-term whether it is safe and how hard side effects are to live with of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents

They plan to enroll about 400 people at 105 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride in Children and Adolescents With Psychiatric Disorders

Interventions: KarXT, KarX-EC

Primary outcome (registry wording): Number of participants with treatment emergent adverse events (TEAEs)

Who it is for (from inclusion criteria)

  • Ages 5 Years to 17 Years

Public study contact (from the registry)

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

105 listed

+ 47 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingPhase 1 / Phase 2Houston, Texas
Phase 1 / Phase 2: testing Ocrelizumab infusion for Schizo-Affective Type of Psychosis

Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies. Auto-antibodies are produced when the normal defense mechanism of the body goes wrong and begins to attack the body, similar to "friendly fire." Auto-antibodies attack brain receptors and then the person who has this problem begins to have hallucinations and other manifestations of schizophrenia, like feeling that people can see what they are thinking and also feeling that other people do not like them.

NCT03971487 · Official ClinicalTrials.gov record · The Methodist Hospital Research Institute

FAQ about this NCT record

Is NCT07424404 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07424404?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07424404?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary