A Phase 2 interventional study of Lumateperone (ITI-007) and Placebo Tablet or Capsule in Stuttering, Adult, sponsored by CSTrials Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by CSTrials Inc. · Phase 2, Interventional, and Treatment
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
This is a double-blind, placebo-controlled trial of Lumateperone in adults who suffer from developmental stuttering. Subjects with moderate to severe stuttering as measure by MLGSS scale will be enrolled. We anticipate screening a total of 30 subjects in anticipation of enrolling 24 suitable subjects for the trial. The subjects will be adults between the ages of 18-65, who have the capacity to consent for themselves. After providing written informed consent, potential subjects will undergo a thorough clinical screening.
74 studies on the registry are indexed under Stuttering; 23 are open to participants now.
This study's planned enrollment of 24 is below the median of 44 across 57 interventional studies indexed under Stuttering.
Browse Stuttering studies →This is the only study on the registry with CSTrials Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects will be included in the study only if they meet all the following criteria:
Exclusion Criteria:
Subjects will be excluded from the study if they meet one or more of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
flexible dosing
Drug: Lumateperone (ITI-007)
Drug: Placebo Tablet or Capsule
This medication is a tablet that is taken once daily
Matching Placebo
Comprehensive Brief Stuttering Assessment-SR (CBSA-SR) previously know as Maguire-Leal-Garibaldi Self rated Stuttering Scale (MLGSSS)
A self rater CBSA-SR includes 10 items to evaluate the different aspects of stuttering during the prior week (last 7 days)
Time frame: last seven days, previous week (Minimum score 0 to Maximum score 100)
Clinical Global Impression - Severity (CGI-S)
Global assessment of stuttering severity (minimum score "1 Normal/Not ill" maximum score "7 Among the most extremely ill patients"
Time frame: Based primarily on symptoms and functioning over the past 7 days
Clinical Global Impression - Improvement (CGI-I)
Global improvement assessment based on post randomization (Minimum score "1 Very much improved" Maximum score "7 Very much worse")
Time frame: Rating for patients illness the past 7 days and measuring if symptoms and functioning have improved or worsened relative to their initial baseline
Plan to share: Undecided — Undecided at this time
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Studies of the drug tested here: Lumateperone