Who is eligible for clinical trial NCT07734103?

Participants must meet the protocol's inclusion criteria for Stuttering, Adult. The stated age range is 18 Years to 65 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07734103 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • 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.

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: CSTrials Inc.

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (10 items).

Location: CSTrials — Costa Mesa, California

Age range: 18 Years to 65 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Subjects will be included in the study only if they meet all the following criteria:
Subject must satisfy DSM-V criteria for childhood onset fluency disorder (stuttering).
The nature of stuttering must be developmental in origin with the onset prior to 8 years of age.
Subject must have a score of moderate or higher on the MLGSSS.
Subject agrees to use an acceptable method of contraception for the duration of the study.
Subject must be able to speak English.
Subjects must be adults between the ages of 18 - 65.

Usually NOT eligible if any of the following apply:

Exclusion Criteria: Subjects will be excluded from the study if they meet one or more of the following criteria:
Subject has an unstable neurologic, psychiatric, or medical condition in the judgement of the investigator.
Subject (female) is pregnant.
Subject has evidence of moderate or severe renal or hepatic impairment at Screening.
Subjects currently taking any moderate or strong CYP3A4 inhibitor medications.
Subject who meets the DSM-5 criteria for moderate to severe substance use disorder within twelve months prior to study inclusion.
Subject has a positive pregnancy test at screening or on Day 1 prior to the start of study drug.
Subject that is lactating at screening or Day 1, prior to the start of study drug and does not agree to cease giving breast milk to child(ren), donating breast milk and/or providing breast milk to anyone for consumption, from Day 1 until 14 days after the last dose of study medication.
Any history of neuroleptic malignant syndrome (NMS).
Subject with a glycosylate hemoglobin (A1c) of greater than 6.4 percent.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

CSTrials — Costa Mesa, California

📞 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.

💰 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 § 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

Effects of Altered Auditory Feedback on Speech Fluency — Cambridge, Massachusetts
Dopamine and Sensorimotor Function in Stuttering — San Francisco, California
Transcranial Alternating Current Stimulation (tACS) in Stuttering — Ann Arbor, Michigan
Using Transcranial Magnetic Stimulation to Treat Stuttering — Manhattan, Kansas

Explore by condition: All Stuttering, Adult clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗