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Can a once-daily pill ease stuttering? a trial puts lumateperone to the test.

NCT ID NCT07734103

Symptom relief Sponsor: CSTrials Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether the drug lumateperone can reduce stuttering symptoms in adults with moderate to severe childhood-onset stuttering. Participants take either lumateperone (21 mg or 42 mg) or a placebo daily for several weeks. Researchers will measure changes in stuttering severity using self-report scales and clinician assessments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a drug called lumateperone (ITI-007) taken as a tablet once daily
What this could lead to
If effective, lumateperone could become a new medication option to help reduce stuttering symptoms in adults.
What could go wrong
This is a small, early-phase trial with only 24 participants, so results may not apply widely. The drug may cause side effects or prove no better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

stutter disorder Stuttering

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stuttering, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CSTrials

    RECRUITING

    Costa Mesa, California, 92662, United States

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