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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Childhood-Onset Fluency Disorder (Stuttering) Drug: Ecopipam Drug: Placebo Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stuttering

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ecopipam HCl ~2mg/kg/day
Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks
 Drug: Ecopipam
Oral tablet
Placebo Comparator: Matching Placebo
Matching placebo tablets for daily, oral administration for 12 weeks
 Drug: Placebo
Oral tablet


Outcome Measures
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Primary Outcome Measures :
  1. Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12 [ Time Frame: 12 weeks ]
    Measures stuttering severity in children and adults


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Kerensa Saljooqi 415-656-7149 ksaljooqi@emalexbiosciences.com

Locations
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United States, California
UC Riverside Active, not recruiting
Riverside, California, United States, 92501
CI Trials Recruiting
Santa Ana, California, United States, 92705
Contact: Tommy Gonzalez    714-912-2499    bestutterfree@gmail.com   
Principal Investigator: Robert Bota, MD,MSG, DFAPA         
United States, Florida
Clinical Neuroscience Solutions Inc Recruiting
Jacksonville, Florida, United States, 32256
Clinical Neuroscience Solutions Inc Recruiting
Orlando, Florida, United States, 32801
United States, Georgia
Institute For Advanced Medical Research Recruiting
Atlanta, Georgia, United States, 30341
United States, Kansas
Social Psychiatry Research Institute Recruiting
Prairie Village, Kansas, United States, 66208
United States, Michigan
Michigan State University Recruiting
East Lansing, Michigan, United States, 48824
United States, New York
Social Psychiatry Research Institute Recruiting
Brooklyn, New York, United States, 11235
United States, Tennessee
Clinical Neuroscience Solutions Inc Recruiting
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Emalex Biosciences Inc.
University of California, Riverside
Premier Research Group plc
Investigators
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Study Director: Atul R Mahableshwarkar, MD, DFAPA Emalex Biosciences Inc.
More Information
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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: November 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emalex Biosciences Inc.:
Stuttering
Communication Disorders
Additional relevant MeSH terms:
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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