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

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emalex Biosciences Inc.
• Collaborators: Premier Research Group plc; University of California, Riverside
• Treatments: Ecopipam

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