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Completed
NCT04492956
Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)
Conditions: Childhood-Onset Fluency Disorder (Stuttering)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 68
Sponsor: Emalex Biosciences Inc.
Location: UC Riverside Riverside California
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 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
Source: ClinicalTrials.gov (NCT04492956). StuddyBuddy aggregates publicly available trial information.