Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder

Part of paid clinical trials in Costa Mesa, California.

Sponsor
CSTrials Inc.
Study ID
NCT07734103
Phase
PHASE2
Status
Recruiting
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Conditions

  • Stuttering, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Lumateperone (ITI-007) — DRUG
    This medication is a tablet that is taken once daily
  • Placebo Tablet or Capsule — DRUG
    Matching Placebo

Study Details

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

Key Dates

First listed
Jul 29, 2026
Start date
Apr 18, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lumateperone 21mg up to 42mg
    flexible dosing
  • Placebo Comparator: Matching Placebo

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CSTrialsCosta MesaCalifornia92662
Tommy Gonzalez, MA
[email protected]
714-900-3969

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CSTrials· Costa Mesa, CA

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