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.
CSTrials Inc.
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
Description
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects will be included in the study only if they meet all the following criteria: 1. Subject must satisfy DSM-V criteria for childhood onset fluency disorder (stuttering). 2. The nature of stuttering must be developmental in origin with the onset prior to 8 years of age. 3. Subject must have a score of moderate or higher on the MLGSSS. 4. Subject agrees to use an acceptable method of contraception for the duration of the study. 5. Subject must be able to speak English. 6. Subjects must be adults between the ages of 18 - 65. Exclusion Criteria: Subjects will be exclud…
Interventions
- DrugLumateperone (ITI-007)
This medication is a tablet that is taken once daily
- DrugPlacebo Tablet or Capsule
Matching Placebo
Location
- CSTrialsCosta Mesa, California