Efficacy and Tolerability of Ecopipam in Adults With Childhood Onset Fluency Disorder (Stuttering). (NCT02909088) | Clinical Trial Compass
UnknownPhase 2/3
Efficacy and Tolerability of Ecopipam in Adults With Childhood Onset Fluency Disorder (Stuttering).
United States10 participantsStarted 2016-09
Plain-language summary
The primary objective of this study is to evaluate the efficacy and tolerability of ecopipam in reducing stuttering symptoms.
It is hypothesized that ecopipam effectively reduces stuttering symptoms as measured on the SSI-IV total score, the CGI, SSS and OASES.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Subjects must satisfy DSM-IV criteria for childhood onset fluency disorder (stuttering).
✓. The nature of stuttering must be developmental in origin with the onset prior to ten years of age.
✓. Subjects must have a score of moderate or higher on the SSI-IV.
✓. Women of child-bearing potential are eligible to participate as long as they are practicing a medically accepted form of contraception (i.e. condom with spermicide or diaphragm, oral or depot contraception, or an intrauterine device).
✓. Subjects will be male or female from the ages of 18-60.
✓. Subject must have a MADRS total score of ≤ 13 (normal mood)
✓. Subjects will be of only English speaking.
Exclusion criteria
✕. Adult individuals who lack capacity to consent for themselves.
✕. Stuttering related to a known neurologic cause (e.g. head trauma, stroke).
✕. Unstable medical or psychiatric illness.
✕. Active substance abuse within three months prior to study inclusion.
✕. Any illness that would require the concomitant use of a CNS active medication during the course of the study.
✕
What they're measuring
1
Change in the Stuttering Severity Instrument Version IV (SSI-IV)
Timeframe: This scale is completed on Visit 1/screening and Visit 5/week 8.