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Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)

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ClinicalTrials.gov Identifier: NCT04492956
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : November 3, 2021
Sponsor:
Collaborators:
University of California, Riverside
Premier Research Group plc
Information provided by (Responsible Party):
Emalex Biosciences Inc.

Tracking Information
First Submitted Date  ICMJE July 27, 2020
First Posted Date  ICMJE July 30, 2020
Last Update Posted Date November 3, 2021
Actual Study Start Date  ICMJE October 2, 2020
Estimated Primary Completion Date March 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12 [ Time Frame: 12 weeks ]
Measures stuttering severity in children and adults
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Childhood-Onset Fluency Disorder (Stuttering)
Intervention  ICMJE
  • Drug: Ecopipam
    Oral tablet
  • Drug: Placebo
    Oral tablet
Study Arms  ICMJE
  • Experimental: Ecopipam HCl ~2mg/kg/day
    Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks
    Intervention: Drug: Ecopipam
  • Placebo Comparator: Matching Placebo
    Matching placebo tablets for daily, oral administration for 12 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 27, 2020)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date March 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kerensa Saljooqi 415-656-7149 ksaljooqi@emalexbiosciences.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04492956
Other Study ID Numbers  ICMJE EBS-101-COFD-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emalex Biosciences Inc.
Study Sponsor  ICMJE Emalex Biosciences Inc.
Collaborators  ICMJE
  • University of California, Riverside
  • Premier Research Group plc
Investigators  ICMJE
Study Director: Atul R Mahableshwarkar, MD, DFAPA Emalex Biosciences Inc.
PRS Account Emalex Biosciences Inc.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP