Childhood-Onset Fluency Disorder (Stuttering)Phase 2NCT04492956
Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)
A Phase 2 study testing Ecopipam in people with Childhood-Onset Fluency Disorder (Stuttering), run by Emalex Biosciences Inc. at 9 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 exploratory study in adult subjects with childhood onset fluency disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Childhood-Onset Fluency Disorder (Stuttering)
- What is being tested?
- Ecopipam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 9 sitesUnited States
- Study dates
- 22 Oct 2020to 4 Apr 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read and write in English and provide informed consent
- 18 years or older of age at screening
- Weighs >= 45 kg (~99 lbs)
- Satisfies DSM-5 criteria for childhood onset fluency disorder
- History of stuttering for >=2 years with onset consistent to developmental in nature
- Must meet an allowed severity of stuttering at screening and baseline, scored by a central rater
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- Completed an adequate course of speech therapy
- Has a qualifying IOS or Android smartphone
- Must discontinue all medications used to treat stuttering for at least 14 days prior to screening
- Sexually active females of child bearing potential must be using effective contraception during and 30 days after participation
- Sexually active males must use a double barrier method of contraception during and 30 days after participation
Who cannot join
- Stuttering is related to a known neurological cause
- Initiation of new behavioral therapies for stuttering within 10 weeks prior to baseline
- Unstable medical illness or clinically significant abnormalities on screening tests/exams
- At a significant risk of committing suicide
- Are pregnant or lactating
- Positive urine drug screen
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- Lifetime history of major depressive episode
- History of seizures
- Have been previously treated with ecopipam
- Unstable use of medications prior to screening
- Use of prohibited medications or need for medications which would have unfavorable interactions with ecopipam
- Not suitable for study in the opinion of the Principle Investigator
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Institute For Advanced Medical Research
Atlanta, Georgia, 30341
Social Psychiatry Research Institute
Brooklyn, New York, 11235
Michigan State University
East Lansing, Michigan, 48824
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, 38119
Clinical Neuroscience Solutions Inc
Orlando, Florida, 32801
Social Psychiatry Research Institute
Prairie Village, Kansas, 66208
UC Riverside
Riverside, California, 92501
CI Trials
Santa Ana, California, 92705
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Exploratory Study to Evaluate the Efficacy and Safety of Ecopipam Tablets in Adults With Childhood Onset Fluency Disorder (Stuttering)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 exploratory study in adult subjects with childhood onset fluency disorder.
Read the detailed description
At the Baseline visit, eligible subjects will be randomized 1:1 to receive either a target steady-state dose of ecopipam HCl ~2 mg/kg/day or matching placebo for a 12-week Treatment Period consisting of a 4-week Titration Phase followed by an 8-week Maintenance Phase.
Subjects will return to the clinic at 4, 8, and 12 weeks after Randomization and Follow-up visits 7 and 14 days after completing the Treatment Period or Early Discontinuation. Efficacy assessments will be conducted at Weeks 4, 8, and 12 and safety assessments will be conducted at all visits. Subjects will have adverse events and other safety parameters assessed by phone or video conference at Weeks 2, 6 and 10 and 30 days after the last study drug administration. Signs or symptoms of withdrawal, abuse, and dependence will be monitored throughout the study.
At the end of the Treatment Period or Early Discontinuation, subjects will taper study drug by 25 mg/day until off study drug, for up to 1 week.
- Being tested
- Ecopipam, Placebo
- Keywords
- Stuttering, Communication Disorders
- Medical subject headings
- Childhood-Onset Fluency Disorder, Stuttering, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EcopipamDrug
Oral tablet
PlaceboDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Ecopipam HCl ~2mg/kg/day | Experimental | Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks Receives: Drug: Ecopipam |
| Matching Placebo | Placebo comparator | Matching placebo tablets for daily, oral administration for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stuttering Severity Instrument, 4th Edition (SSI-4)
The SSI-4 is a reliable and valid norm-referenced stuttering assessment that can be used for both clinical and research purposes. It takes 15-20 minutes to complete. It measures stuttering severity in both children and adults in the 4 areas of speech behavior:1. frequency 2. duration 3. physical concomitants 4. naturalness of the individual's speech.
Frequency is expressed in percent of syllables stuttered and is converted to scale scores of 2-18. Duration is timed to the nearest one tenth of a second and is converted to scale scores of 2-18. The 4 types of physical concomitants are converted to scale scores of 0-56.
Measured: 12 weeks
Secondary outcomes (2)
Clinical Global Impression - Severity (CGI-S) Baseline to Week 12
The CGI consists of two reliable and valid 7-item Likert scales used to assess severity and change in clinical symptoms. The severity scale (CGI-S) ranges from 1 (Normal, not ill) to 7 (extremely ill). Pediatric and adult versions of the CGI-TS-S and CGI-TS-I scales are available and will be administered according to the age of the subject at the time of Informed Consent. The efforts of peers, teachers and parents to assist, accommodate, or support the subject should be considered in overall severity in the case of pediatric subjects.
Measured: Baseline, Week 4, Week 8 and 12 weeks
Change From Baseline Subjective Screening of Stuttering (SSS)
The Subjective Screening of Stuttering (SSS) research edition is designed to quantify the selected self-reports of people who stutter prior to, during, and following their treatment. The three areas screened by the SSS are perceived stuttering severity (range 3-27), the locus of control subtest (range 6-54), and reported word or situation avoidance (range 6-54). Each of the areas has two or three items rated for three audiences on a 1 to 9, equal appearing scale in which 1 represents "normal" or target level and 9 is the most severe. The total score has a range of 15-135. Higher scores indicate greater severity.
Measured: From baseline (enrollment) to Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start22 Oct 2020
- Primary completion7 Mar 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood-Onset Fluency Disorder (Stuttering)Studies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emalex Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Riverside, Premier Research
- Responsible party
- Sponsor
- Investigators
- Atul R Mahableshwarkar, MD, DFAPA, Study director, Emalex Biosciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492956
- Sponsor's protocol ID
- EBS-101-COFD-201
- Status last verified
- Aug 2025
- First submitted
- 27 Jul 2020
- Last updated
- 23 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Exploratory Study to Evaluate the Efficacy and Safety of Ecopipam Tablets in Adults With Childhood Onset Fluency Disorder (Stuttering)
- ClinicalTrials.gov ID
- NCT04492956
- Acronym / sponsor ID
- EBS-101-COFD-201
- Keywords
- Stuttering, Communication Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Emalex Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, Riverside, Premier Research
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Posted 23 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 exploratory study in adult subjects with childhood onset fluency disorder.
Detailed description
At the Baseline visit, eligible subjects will be randomized 1:1 to receive either a target steady-state dose of ecopipam HCl ~2 mg/kg/day or matching placebo for a 12-week Treatment Period consisting of a 4-week Titration Phase followed by an 8-week Maintenance Phase.
Subjects will return to the clinic at 4, 8, and 12 weeks after Randomization and Follow-up visits 7 and 14 days after completing the Treatment Period or Early Discontinuation. Efficacy assessments will be conducted at Weeks 4, 8, and 12 and safety assessments will be conducted at all visits. Subjects will have adverse events and other safety parameters assessed by phone or video conference at Weeks 2, 6 and 10 and 30 days after the last study drug administration. Signs or symptoms of withdrawal, abuse, and dependence will be monitored throughout the study.
At the end of the Treatment Period or Early Discontinuation, subjects will taper study drug by 25 mg/day until off study drug, for up to 1 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ecopipam HCl ~2mg/kg/day | Experimental | Drug: EcopipamEcopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks |
| Matching Placebo | Placebo comparator | Drug: PlaceboMatching placebo tablets for daily, oral administration for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able to read and write in English and provide informed consent
- 18 years or older of age at screening
- Weighs >= 45 kg (~99 lbs)
- Satisfies DSM-5 criteria for childhood onset fluency disorder
- History of stuttering for >=2 years with onset consistent to developmental in nature
Key exclusion criteria (12 listed)
- Stuttering is related to a known neurological cause
- Initiation of new behavioral therapies for stuttering within 10 weeks prior to baseline
- Unstable medical illness or clinically significant abnormalities on screening tests/exams
- At a significant risk of committing suicide
- Are pregnant or lactating
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 |
|---|---|---|
| EcopipamOral tablet | Drug | Ecopipam HCl ~2mg/kg/day |
| PlaceboOral tablet | Drug | Matching Placebo |
Primary outcome
Stuttering Severity Instrument, 4th Edition (SSI-4)
Time frame: 12 weeks
The SSI-4 is a reliable and valid norm-referenced stuttering assessment that can be used for both clinical and research purposes. It takes 15-20 minutes to complete. It measures stuttering severity in both children and adults in the 4 areas of speech behavior:1. frequency 2. duration 3. physical concomitants 4. naturalness of the individual's speech. Frequency is expressed in percent of syllables stuttered and is converted to scale scores of 2-18. Duration is timed to the nearest one tenth of a second and is converted to scale scores of 2-18. The 4 types of physical concomitants are converted to scale scores of 0-56.
2 secondary outcomes
Clinical Global Impression - Severity (CGI-S) Baseline to Week 12
Time frame: Baseline, Week 4, Week 8 and 12 weeks
Change From Baseline Subjective Screening of Stuttering (SSS)
Time frame: From baseline (enrollment) to Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Atul R Mahableshwarkar, MD, DFAPA study director
Emalex Biosciences Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ecopipam in people with Childhood-Onset Fluency Disorder (Stuttering), run by Emalex Biosciences Inc. at 9 sites 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 11 inclusion and 12 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: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Yes. Results are posted in the registry (first posted 23 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stuttering Severity Instrument, 4th Edition (SSI-4) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.