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Trial · NCT07424404

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

NCT07424404, Phase 3, Recruiting, Karuna Therapeutics, Inc., a Bristol Myers Squibb company

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. 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. Trials, record NCT07424404. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07424404

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
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
NCT number
NCT07424404
Status
Recruiting
Phases
Phase 3
Enrollment
400 participants, estimated
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions
Schizophrenia, Autism-Related Irritability
Interventions
KarXT, KarX-EC
First posted
2026-02-20
Last updated
2026-11-06

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of participants with treatment emergent adverse events (TEAEs)Up to 56 weeks
PrimaryNumber of participants with adverse events of special interest (AESIs)Up to 56 weeks
PrimaryNumber of participants with serious adverse events (SAEs)Up to 56 weeks
SecondaryNumber or participants with cholinergic symptomsUp to 56 weeks
SecondaryNumber of participants with anticholinergic symptomsUp to 56 weeks
SecondaryNumber of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)Up to 56 weeks
SecondaryChange from baseline on the Simpson-Angus Scale (SAS)Up to 52 weeks
SecondaryChange from baseline on the Abnormal Involuntary Movement Scale (AIMS)Up to 52 weeks
SecondaryChange from baseline on the Barnes-Akathisia Rating Scale (BARS)Up to 52 weeks

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07424404

GET https://conductscience.org/api/trials/v1/NCT07424404/registered