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 Xanomeline/Trospium Chloride for Schizophrenia

The purpose of the study is to measure the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Official registry: https://clinicaltrials.gov/study/NCT07686263 · Karuna Therapeutics, Inc., a Bristol Myers Squibb company · enrollment listed as 472

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 Xanomeline/Trospium Chloride, or Placebo. The registry lists allocation as randomized. The purpose of the study is to measure the relapse prevention of KarXT in the treatment of participants with Schizophrenia

They plan to enroll about 472 people at 54 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia

Interventions: Xanomeline/Trospium Chloride, Placebo

Primary outcome (registry wording): Time From Randomization to the First Relapse Event

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date
  • Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1
  • Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:
  • Item 1 (P1; delusions)
  • Item 2 (P2; conceptual disorganization)
  • Item 3 (P3; hallucinatory behavior)
  • Item 6 (P6; suspiciousness/persecution)

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

54 listed

+ 22 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 NCT07686263 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 NCT07686263?

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 NCT07686263?

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