Lumateperone for Stuttering (Childhood Onset Fluency Disorder)

This study is testing a medication called Lumateperone (ITI-007) to see if it can help reduce stuttering symptoms in adults. You might be able to join if you are between 18 and 65 years old, have stuttering that started before age 8, and your stuttering is considered moderate to severe. Researchers will compare Lumateperone to a placebo (a pill with no active medicine) to see how well it works and if it's well-tolerated. Success will be measured by changes in your self-rated stuttering severity and how much your overall condition has improved. The study is currently unclear on its recruitment status and plans to enroll about 24 participants.

Study design
This is a double-blind, placebo-controlled study, meaning neither you nor your doctor will know if you are receiving Lumateperone or the placebo. It aims to enroll 24 adult participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your stuttering will be measured during the last seven days of the study, and your overall condition will be assessed based on symptoms over the past 7 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07734103

Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder

Recruiting
PHASE2Ages 18–65InterventionalTreatment
CSTrials Inc.
~24 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Lumateperone (ITI-007)Placebo Tablet or Capsule

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comprehensive Brief Stuttering Assessment-SR (CBSA-SR) previously know as Maguire-Leal-Garibaldi Self rated Stuttering Scale (MLGSSS)
Measured over last seven days, previous week (Minimum score 0 to Maximum score 100)
+1 more outcome measured
Stuttering, Adult
1 sites across 1 states
California1
  • Gerald A Maguire, MD · PRINCIPAL_INVESTIGATOR · CSTrials Inc.

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  • Comprehensive Brief Stuttering Assessment-SR (CBSA-SR) previously know as Maguire-Leal-Garibaldi Self rated Stuttering Scale (MLGSSS)last seven days, previous week (Minimum score 0 to Maximum score 100)

    A self rater CBSA-SR includes 10 items to evaluate the different aspects of stuttering during the prior week (last 7 days)

  • Clinical Global Impression - Severity (CGI-S)Based primarily on symptoms and functioning over the past 7 days

    Global assessment of stuttering severity (minimum score "1 Normal/Not ill" maximum score "7 Among the most extremely ill patients"