Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Lumateperone (ITI-007)

    Drug

    This medication is a tablet that is taken once daily

  • Placebo Tablet or Capsule

    Drug

    Matching Placebo

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Lumateperone 21mg up to 42mgExperimental treatment 1 intervention
Group B: Matching PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Comprehensive Brief Stuttering Assessment-SR (CBSA-SR) previously know as Maguire-Leal-Garibaldi Self rated Stuttering Scale (MLGSSS)

A self rater CBSA-SR includes 10 items to evaluate the different aspects of stuttering during the prior week (last 7 days)

Time frame
last seven days, previous week (Minimum score 0 to Maximum score 100)
2

Clinical Global Impression - Severity (CGI-S)

Global assessment of stuttering severity (minimum score "1 Normal/Not ill" maximum score "7 Among the most extremely ill patients"

Time frame
Based primarily on symptoms and functioning over the past 7 days

Secondary outcomes

1

Clinical Global Impression - Improvement (CGI-I)

Global improvement assessment based on post randomization (Minimum score "1 Very much improved" Maximum score "7 Very much worse")

Time frame
Rating for patients illness the past 7 days and measuring if symptoms and functioning have improved or worsened relative to their initial baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSTrials Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now