Menu
Recruiting NCT07734103

Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder

Phase II Interventional Stuttering, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lumateperone (ITI-007), Placebo Tablet or Capsule.
Who it may be relevant to
Registry conditions: Stuttering, Adult. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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

Detailed 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.

Interventions

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

Primary outcome measures

  • 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)]
  • Clinical Global Impression - Severity (CGI-S) [Time frame: Based primarily on symptoms and functioning over the past 7 days]
Secondary outcome measures (1)
  • Clinical Global Impression - Improvement (CGI-I) [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]

Eligibility criteria

Inclusion criteria

Subjects will be included in the study only if they meet all the following criteria:

  • 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.
  • Subject must be able to speak English.
  • Subjects must be adults between the ages of 18 - 65.

Exclusion criteria

Subjects will be excluded from the study if they meet one or more of the following criteria:

  • 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.
  • Subject who meets the DSM-5 criteria for moderate to severe substance use disorder within twelve months prior to study inclusion.
  • Subject has a positive pregnancy test at screening or on Day 1 prior to the start of study drug.
  • Subject that is lactating at screening or Day 1, prior to the start of study drug and does not agree to cease giving breast milk to child(ren), donating breast milk and/or providing breast milk to anyone for consumption, from Day 1 until 14 days after the last dose of study medication.
  • Any history of neuroleptic malignant syndrome (NMS).
  • Subject with a glycosylate hemoglobin (A1c) of greater than 6.4 percent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • CSTrials — Costa Mesa

Publications

  • Maguire GA, Yoo BR, SheikhBahaei S. Investigation of Risperidone Treatment Associated With Enhanced Brain Activity in Patients Who Stutter. Front Neurosci. 2021 Feb 12;15:598949. doi: 10.3389/fnins.2021.598949. eCollection 2021. PMID 33642973
  • Charoensook J, Maguire GA. A case series on the effectiveness of lurasidone in patients with stuttering. Ann Clin Psychiatry. 2017 Aug;29(3):191-194. PMID 28738099
  • Maguire GA, LaSalle L, Hoffmeyer D, Nelson M, Lochhead JD, Davis K, Burris A, Yaruss JS. Ecopipam as a pharmacologic treatment of stuttering. Ann Clin Psychiatry. 2019 Aug;31(3):164-168. PMID 31369655

Identifiers

NCT: NCT07734103 · ITI-IIT-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗