Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04492956 |
Recruitment Status :
Completed
First Posted : July 30, 2020
Last Update Posted : April 28, 2022
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Condition or disease | Intervention/treatment | Phase |
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Childhood-Onset Fluency Disorder (Stuttering) | Drug: Ecopipam Drug: Placebo | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | October 2, 2020 |
Actual Primary Completion Date : | March 7, 2022 |
Actual Study Completion Date : | April 4, 2022 |
Arm | Intervention/treatment |
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Experimental: Ecopipam HCl ~2mg/kg/day
Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks
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Drug: Ecopipam
Oral tablet |
Placebo Comparator: Matching Placebo
Matching placebo tablets for daily, oral administration for 12 weeks
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Drug: Placebo
Oral tablet |
- Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12 [ Time Frame: 12 weeks ]Measures stuttering severity in children and adults
- Clinical Global Impression - Severity (CGI-S) baseline to Week 12 [ Time Frame: 12 weeks ]Rates the severity of the subject's illness at the time of assessment, relative to the the clinician's past experience with patients who have the same diagnosis.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492956
United States, California | |
UC Riverside | |
Riverside, California, United States, 92501 | |
CI Trials | |
Santa Ana, California, United States, 92705 | |
United States, Florida | |
Clinical Neuroscience Solutions Inc | |
Jacksonville, Florida, United States, 32256 | |
Clinical Neuroscience Solutions Inc | |
Orlando, Florida, United States, 32801 | |
United States, Georgia | |
Institute For Advanced Medical Research | |
Atlanta, Georgia, United States, 30341 | |
United States, Kansas | |
Social Psychiatry Research Institute | |
Prairie Village, Kansas, United States, 66208 | |
United States, Michigan | |
Michigan State University | |
East Lansing, Michigan, United States, 48824 | |
United States, New York | |
Social Psychiatry Research Institute | |
Brooklyn, New York, United States, 11235 | |
United States, Tennessee | |
Clinical Neuroscience Solutions Inc | |
Memphis, Tennessee, United States, 38119 |
Study Director: | Atul R Mahableshwarkar, MD, DFAPA | Emalex Biosciences Inc. |
Responsible Party: | Emalex Biosciences Inc. |
ClinicalTrials.gov Identifier: | NCT04492956 |
Other Study ID Numbers: |
EBS-101-COFD-201 |
First Posted: | July 30, 2020 Key Record Dates |
Last Update Posted: | April 28, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Stuttering Communication Disorders |
Stuttering Childhood-Onset Fluency Disorder Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Neurodevelopmental Disorders Mental Disorders |
Ecopipam Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |