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

Completed · Phase 2 · Has a placebo group

Conditions studied: Childhood-Onset Fluency Disorder (Stuttering)

In brief

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

Key facts

Study ID

NCT04492956

Run by

Emalex Biosciences Inc.

People needed

68

Starts

2020-10-02

Expected to finish

2022-04-04

Last updated by the study team

2022-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC Riverside — Riverside, California, United States
• CI Trials — Santa Ana, California, United States
• Clinical Neuroscience Solutions Inc — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions Inc — Orlando, Florida, United States
• Institute For Advanced Medical Research — Atlanta, Georgia, United States
• Social Psychiatry Research Institute — Prairie Village, Kansas, United States
• Michigan State University — East Lansing, Michigan, United States
• Social Psychiatry Research Institute — Brooklyn, New York, United States
• Clinical Neuroscience Solutions Inc — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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