Back to resultsEffects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)
Primary Purpose
Childhood-Onset Fluency Disorder (Stuttering)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ecopipam
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Childhood-Onset Fluency Disorder (Stuttering) focused on measuring Stuttering, Communication Disorders
Eligibility Criteria
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
Sites / Locations
- UC Riverside
- CI Trials
- Clinical Neuroscience Solutions Inc
- Clinical Neuroscience Solutions Inc
- Institute For Advanced Medical Research
- Social Psychiatry Research Institute
- Michigan State University
- Social Psychiatry Research Institute
- Clinical Neuroscience Solutions Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ecopipam HCl ~2mg/kg/day
Matching Placebo
Arm Description
Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks
Matching placebo tablets for daily, oral administration for 12 weeks
Outcomes
Primary Outcome Measures
Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12
Measures stuttering severity in children and adults
Secondary Outcome Measures
Clinical Global Impression - Severity (CGI-S) baseline to Week 12
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.
Full Information
NCT ID
NCT04492956
First Posted
July 27, 2020
Last Updated
April 26, 2022
Sponsor
Emalex Biosciences Inc.
Collaborators
University of California, Riverside, Premier Research Group plc
1. Study Identification
Unique Protocol Identification Number
NCT04492956
Brief Title
Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
March 7, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emalex Biosciences Inc.
Collaborators
University of California, Riverside, Premier Research Group plc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood-Onset Fluency Disorder (Stuttering)
Keywords
Stuttering, Communication Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ecopipam HCl ~2mg/kg/day
Arm Type
Experimental
Arm Description
Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets for daily, oral administration for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ecopipam
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12
Description
Measures stuttering severity in children and adults
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Severity (CGI-S) baseline to Week 12
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul R Mahableshwarkar, MD, DFAPA
Organizational Affiliation
Emalex Biosciences Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UC Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
CI Trials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Clinical Neuroscience Solutions Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Clinical Neuroscience Solutions Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Institute For Advanced Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Social Psychiatry Research Institute
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Social Psychiatry Research Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Clinical Neuroscience Solutions Inc
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)
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