RecruitingPhase 2NCT07734103

Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder

A Single-Center, Double-Blind, Placebo-Controlled, Study to Evaluate Lumateperone, Flexible Doses of 21mg or 42mg in Patients With Moderate to Severe Childhood Onset Fluency Disorder, Stuttering.

Sponsor

CSTrials Inc.

Enrollment

24 participants

Start Date

Apr 18, 2026

Study Type

INTERVENTIONAL

Conditions

Stuttering, Adult

Summary

The primary objective of this study is to evaluate the efficacy and tolerability of Lumateperone in reducing stuttering symptoms. The following scales and samples will be collected for clinical and functional outcomes. • MLGSSS • SSS • Stuttering Severity Instrument (SSI-IV) • PHQ-9 • Barnes Akathisia • SAS • AIMS • CGI-I • CGI-S

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lumateperone (ITI-007) and a drug called Placebo Tablet or Capsule for people with stuttering, adult. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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