Lumateperone for childhood-onset stuttering in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, double-blind, placebo-controlled trial evaluating lumateperone (ITI-007) in adults aged 18-65 with developmental stuttering beginning before age 8. Participants will be randomized to receive lumateperone or placebo and will be assessed on multiple stuttering and quality-of-life scales, alongside safety measures. The study plans to screen about 30 individuals to enroll 24 suitable subjects across a trial at CSTrials in Costa Mesa, CA. Eligibility requires DSM-5 childhood onset fluency disorder with moderate or higher stuttering on a standardized scale, English proficiency, and contraception use if applicable. Exclusion criteria include unstable medical or psychiatric conditions, pregnancy, significant renal/hepatic impairment, or use of certain CYP3A4 inhibitors.

Why it matters

Who can join: the full rules

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.

Where it's running

• CSTrials
  Costa Mesa, California, United States Recruiting

Study contacts

• Principal investigator: Gerald A Maguire, MD — CSTrials Inc.
• Study coordinator: Tommy Gonzalez, MA
• Email: Tommy@CSTrials.com
• Phone: 1-714-900-3969

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcranial magnetic stimulation for adult stuttering

  We will test whether repeated transcranial magnetic stimulation (rTMS) to a language-related brain area can reduce stuttering in adults who stutter.

  Recruiting Kansas State University · Manhattan, Kansas · NCT07389694

• Aripiprazole and sensorimotor function in adults who stutter

  We will test whether a single 10 mg dose of aripiprazole versus placebo changes speech sensorimotor processing and improves fluency in adults who stutter.

  Recruiting Phase 1 University of California, San Francisco · San Francisco, California · NCT07215884

• Motor brain circuits for speech production in adults who stutter

  We will use MRI while adults who stutter speak to test how motor brain areas and their connections work during continuous speech.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07180628

• Delta-frequency alternating-current brain stimulation paired with choral reading for stuttering

  This project will try mild, noninvasive alternating-current brain stimulation (tACS) paired with choral reading to see if it reduces stuttering in English-speaking children and adults who currently stutter.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT06740968

• Exploring the nature and treatment of stuttering

  This study is testing new ways to treat stuttering by looking at the different factors that affect it in both one-language and multiple-language speakers.

  Recruiting University of Texas at Austin · Austin, Texas · NCT05908123

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.