NCT07734103 · CSTrials Inc.
Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder
What this study is about
The primary objective of this study is to evaluate the effectiveness and tolerability of Lumateperone in reducing stuttering symptoms. The following scales and samples will be collected for clinical and functional outcomes.
View original scientific description
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.
Interventions
DRUG
Lumateperone (ITI-007)
This medication is a tablet that is taken once daily
DRUG
Placebo Tablet or Capsule
Matching Placebo
Primary outcome measures
Comprehensive Brief Stuttering Assessment-SR (CBSA-SR) previously know as Maguire-Leal-Garibaldi Self rated Stuttering Scale (MLGSSS)
Time frame: last seven days, previous week (Minimum score 0 to Maximum score 100)
A self rater CBSA-SR includes 10 items to evaluate the different aspects of stuttering during the prior week (last 7 days)
Clinical Global Impression - Severity (CGI-S)
Time frame: Based primarily on symptoms and functioning over the past 7 days
Global assessment of stuttering severity (minimum score "1 Normal/Not ill" maximum score "7 Among the most extremely ill patients"
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
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.
Where
- Costa Mesa, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2026 · Source of record for eligibility and locations