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Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder

NCT07734103 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-07-29

No results posted yet for this study

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

Conditions

  • Stuttering, Adult

Interventions

DRUG

Lumateperone (ITI-007)

This medication is a tablet that is taken once daily

DRUG

Placebo Tablet or Capsule

Matching Placebo

Sponsors & Collaborators

  • CSTrials Inc.

    lead NETWORK

Principal Investigators

  • Gerald A Maguire, MD · CSTrials Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-18
Primary Completion
2027-07-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734103 on ClinicalTrials.gov