Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder (NCT07734103) | Clinical Trial Compass
RecruitingPhase 2
Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder
United States24 participantsStarted 2026-04-18
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).