๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-24

Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder (NCT07734103)

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.

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: CSTrials Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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. โ€ข MLGSSS โ€ข SSS โ€ข Stuttering Severity Instrument (SSI-IV) โ€ข PHQ-9 โ€ข Barnes Akathisia โ€ข SAS โ€ข AIMS โ€ข CGI-I โ€ข CGI-S

Who can join: Review the eligibility criteria below.

Location: CSTrials โ€” Costa Mesa, California

Age range: 18 Years to 65 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • CSTrials โ€” Costa Mesa, California

๐Ÿ“ž Contact the Study Coordinator

Phone: (714) 900-3969

Email: Tommy@CSTrials.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Stuttering, Adult

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—