Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder

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.

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

Study Overview

• Status: Recruiting
• Conditions: Stuttering, Adult
• Intervention / Treatment: Drug: Lumateperone (ITI-007); Drug: Placebo Tablet or Capsule

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tommy Gonzalez, MA; Phone Number: 1-714-900-3969; Email: Tommy@CSTrials.com
• Study Contact Backup: Name: Debra Hoffmeyer, MA; Phone Number: 1-888-421-2782; Email: debra@cstrials.com

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92662
      • Recruiting
      • CSTrials
      • Contact: Tommy Gonzalez, MA; Phone Number: 714-900-3969; Email: Tommy@CSTrials.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

1. Subject must satisfy DSM-V criteria for childhood onset fluency disorder (stuttering).
2. The nature of stuttering must be developmental in origin with the onset prior to 8 years of age.
3. Subject must have a score of moderate or higher on the MLGSSS.
4. Subject agrees to use an acceptable method of contraception for the duration of the study.
5. Subject must be able to speak English.
6. 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:

1. Subject has an unstable neurologic, psychiatric, or medical condition in the judgement of the investigator.
2. Subject (female) is pregnant.
3. Subject has evidence of moderate or severe renal or hepatic impairment at Screening.
4. Subjects currently taking any moderate or strong CYP3A4 inhibitor medications.
5. Subject who meets the DSM-5 criteria for moderate to severe substance use disorder within twelve months prior to study inclusion.
6. Subject has a positive pregnancy test at screening or on Day 1 prior to the start of study drug.
7. 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.
8. Any history of neuroleptic malignant syndrome (NMS).
9. Subject with a glycosylate hemoglobin (A1c) of greater than 6.4 percent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Matching Placebo	Drug: Placebo Tablet or Capsule; Matching Placebo
Experimental: Lumateperone 21mg up to 42mg; flexible dosing	Drug: Lumateperone (ITI-007); This medication is a tablet that is taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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")	Rating for patients illness the past 7 days and measuring if symptoms and functioning have improved or worsened relative to their initial baseline

Collaborators and Investigators

• Sponsor: CSTrials Inc.
• Investigators: Principal Investigator: Gerald A Maguire, MD, CSTrials Inc.

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: July 24, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: stuttering
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Speech Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stuttering; Pharmaceutical Preparations; Dosage Forms; lumateperone; Capsules
• Other Study ID Numbers: ITI-IIT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided at this time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes