Evaluation of Lumateperone Tablets for Adults with Moderate to Severe Childhood-Onset Stuttering Double-Blind, Placebo-Controlled Phase 2 Trial

What this Trial Is About

Researchers are evaluating Lumateperone as a treatment for adults with developmental stuttering, also known as childhood-onset fluency disorder. This double-blind, placebo-controlled Phase 2 trial focuses on adults aged 18 to 65 with moderate to severe stuttering symptoms. The study aims to assess both the effectiveness and tolerability of Lumateperone in reducing stuttering. Participants will be randomly assigned to receive either Lumateperone tablets, taken once daily with flexible dosing from 21 mg up to 42 mg, or a matching placebo. The trial uses a parallel design and includes multiple outcome assessments such as the Maguire-Leal-Garibaldi Self-Rated Stuttering Scale MLGSSS, Clinical Global Impression scales, and other measures of stuttering severity and side effects. The study is planned to enroll 24 subjects, with screening of about 30 to find suitable candidates. During the study, participants will undergo thorough clinical screening and provide written consent before enrollment. Researchers will collect various clinical scales and samples, including stuttering severity instruments and assessments for psychiatric and movement-related side effects. The primary outcomes include changes in stuttering severity and global impression of symptoms over the past week. The total study period extends until late 2027, with ongoing monitoring of efficacy and safety throughout the trial.

Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder