Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT04492956
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04492956
Study Brief:
Protocol Section:
NCT04492956