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

Last updated: April 26, 2022
Sponsor: Emalex Biosciences Inc.
Overall Status: Completed

Phase

2

Condition

Communication Disorders

Speech Disorders

Treatment

N/A

Clinical Study ID

NCT04492956
EBS-101-COFD-201
  • Ages > 18
  • All Genders

Study Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 exploratory study in adult subjects with childhood onset fluency disorder.

Eligibility Criteria

Inclusion

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 acentral 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 priorto screening
  • Sexually active females of child bearing potential must be using effectivecontraception during and 30 days after participation
  • Sexually active males must use a double barrier method of contraception during and 30days after participation

Exclusion

Exclusion Criteria:

  • Stuttering is related to a known neurological cause
  • Initiation of new behavioral therapies for stuttering within 10 weeks prior tobaseline
  • Unstable medical illness or clinically significant abnormalities on screeningtests/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 unfavorableinteractions with ecopipam
  • Not suitable for study in the opinion of the Principle Investigator

Study Design

Total Participants: 68
Study Start date:
October 02, 2020
Estimated Completion Date:
April 04, 2022

Study 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.

Connect with a study center

  • UC Riverside

    Riverside, California 92501
    United States

    Site Not Available

  • CI Trials

    Santa Ana, California 92705
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Inc

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Inc

    Orlando, Florida 32801
    United States

    Site Not Available

  • Institute For Advanced Medical Research

    Atlanta, Georgia 30341
    United States

    Site Not Available

  • Social Psychiatry Research Institute

    Prairie Village, Kansas 66208
    United States

    Site Not Available

  • Michigan State University

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Social Psychiatry Research Institute

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Inc

    Memphis, Tennessee 38119
    United States

    Site Not Available

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