Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder

NCT07734103 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ITI-IIT-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stuttering, Adult

Keywords

stuttering

Outcome Measures

Primary Outcomes (2)

• 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)

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

• 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"

  Based primarily on symptoms and functioning over the past 7 days

Secondary Outcomes (1)

• Clinical Global Impression - Improvement (CGI-I)

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

Study Arms (2)

Lumateperone 21mg up to 42mg

EXPERIMENTAL

flexible dosing

Drug: Lumateperone (ITI-007)

Matching Placebo

PLACEBO COMPARATOR

Drug: Placebo Tablet or Capsule

Interventions

Lumateperone (ITI-007) DRUG

This medication is a tablet that is taken once daily

Lumateperone 21mg up to 42mg

Placebo Tablet or Capsule DRUG

Matching Placebo

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• CSTrials Inc.: lead

Study Sites (1)

CSTrials

Costa Mesa, California, 92662, United States

RECRUITING

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Stuttering

Interventions

lumateperone; Capsules

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Gerald A Maguire, MD

  CSTrials Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommy Gonzalez, MA

CONTACT

1-714-900-3969; Tommy@CSTrials.com

Debra Hoffmeyer, MA

CONTACT

1-888-421-2782; debra@cstrials.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Flexible Dosing

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: July 29, 2026
• Study Start: April 18, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

US (1)