Status:
COMPLETED
Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)
Lead Sponsor:
Emalex Biosciences Inc.
Collaborating Sponsors:
University of California, Riverside
Premier Research
Conditions:
Childhood-Onset Fluency Disorder (Stuttering)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04492956
Start Date
October 2 2020
End Date
April 4 2022
Last Update
April 28 2022
Active Locations (9)
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1
UC Riverside
Riverside, California, United States, 92501
2
CI Trials
Santa Ana, California, United States, 92705
3
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, United States, 32256
4
Clinical Neuroscience Solutions Inc
Orlando, Florida, United States, 32801