Stuttering, AdultPhase 2NCT07734103
Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder
A Phase 2 study testing Lumateperone (ITI-007) in people with Stuttering, Adult, run by CSTrials Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stuttering, Adult
- What is being tested?
- Lumateperone (ITI-007)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2026to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CSTrials
Costa Mesa, California, 92662
Tommy Gonzalez, MA, 714-900-3969, Tommy@CSTrials.com
About this study
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.
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
Read the 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.
- Conditions
- Stuttering, Adult
- Being tested
- Lumateperone (ITI-007), Placebo Tablet or Capsule
- Keywords
- stuttering
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumateperone (ITI-007)Drug
This medication is a tablet that is taken once daily
Placebo Tablet or CapsuleDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lumateperone 21mg up to 42mg | Experimental | flexible dosing Receives: Drug: Lumateperone (ITI-007) |
| Matching Placebo | Placebo comparator | Not described Receives: Drug: Placebo Tablet or Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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"
Measured: Based primarily on symptoms and functioning over the past 7 days
Secondary outcomes (1)
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")
Measured: Rating for patients illness the past 7 days and measuring if symptoms and functioning have improved or worsened relative to their initial baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start18 Apr 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stuttering, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Flexible Dosing
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSTrials Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gerald A Maguire, MD, Principal investigator, CSTrials Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734103
- Sponsor's protocol ID
- ITI-IIT-001
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this time
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.
PubMed 33642973Charoensook J, Maguire GA. A case series on the effectiveness of lurasidone in patients with stuttering. Ann Clin Psychiatry. 2017 Aug;29(3):191-194.
PubMed 28738099Maguire 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.
PubMed 31369655
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07734103
- Acronym / sponsor ID
- ITI-IIT-001
- Conditions
- Stuttering, Adult
- Keywords
- stuttering
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- CSTrials Inc.Research network
- Study start
- 18 Apr 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Flexible Dosing
| Arm | Type | Receives |
|---|---|---|
| Lumateperone 21mg up to 42mg | Experimental | Drug: Lumateperone (ITI-007)flexible dosing |
| Matching Placebo | Placebo comparator | Drug: Placebo Tablet or Capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumateperone (ITI-007)This medication is a tablet that is taken once daily | Drug | Lumateperone 21mg up to 42mg |
| Placebo Tablet or CapsuleMatching Placebo | Drug | Matching Placebo |
Primary outcome
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)
A self rater CBSA-SR includes 10 items to evaluate the different aspects of stuttering during the prior week (last 7 days)
Clinical Global Impression - Severity (CGI-S)
Time frame: Based primarily on symptoms and functioning over the past 7 days
Global assessment of stuttering severity (minimum score "1 Normal/Not ill" maximum score "7 Among the most extremely ill patients"
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Results publication: PubMed 33642973Maguire 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.
- Results publication: PubMed 28738099Charoensook J, Maguire GA. A case series on the effectiveness of lurasidone in patients with stuttering. Ann Clin Psychiatry. 2017 Aug;29(3):191-194.
- Results publication: PubMed 31369655Maguire 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.
- Individual participant dataSharing planned: Undecided. Undecided at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerald A Maguire, MD principal investigator
CSTrials Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lumateperone (ITI-007) in people with Stuttering, Adult, run by CSTrials Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommy Gonzalez, MA (1-714-900-3969, Tommy@CSTrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07734103, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.