Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder
ConditionStuttering, Adult
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCSTrials Inc.
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Lumateperone (ITI-007)
- Placebo Tablet or Capsule
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov