Efficacy and Tolerability of Ecopipam in Adults With Childhood Onset Fluency Disorder (Stuttering).

• Status: Unknown status
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gerald Maguire, MD
• Collaborator: University of California Riverisde School of Medicine
• Treatments: Ecopipam

Criteria

Inclusion Criteria:

Subjects can be enrolled in the study only if they meet all of the following criteria:

1. Subjects must satisfy DSM-IV criteria for childhood onset fluency disorder (stuttering).

2. The nature of stuttering must be developmental in origin with the onset prior to ten years of age.

3. Subjects must have a score of moderate or higher on the SSI-IV.

4. 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).

5. Subjects will be male or female from the ages of 18-60.

6. Subject must have a MADRS total score of ≤ 13 (normal mood)

7. Subjects will be of only English speaking.

Exclusion Criteria:

Subjects will be excluded from the study for any of the following reasons:

1. Adult individuals who lack capacity to consent for themselves.

2. Stuttering related to a known neurologic cause (e.g. head trauma, stroke).

3. Unstable medical or psychiatric illness.

4. Active substance abuse within three months prior to study inclusion.

5. Any illness that would require the concomitant use of a CNS active medication during the course of the study.

6. Subjects with Parkinson's dementia or other degenerative neurologic illness.

7. Suffer from irregular heart rate or seizures

8. Subjects who are pregnant or nursing an infant.

9. Subject with a MADRS ≥ 14

10. Breastfeeding a child during the course of the study or for one month following completion

11. It is the investigator's opinion that the subject poses a significant suicide risk by the following criteria:

1. It is the investigator's opinion that the subject may be at risk of suicide.

2. the subject responds "yes" to question #4 (Active Suicidal Ideation with Specific Plan and Intent) on the Baseline Visit of the Columbia Suicide Severity Rating Scale (C-SSRS), if the most recent episode occurred within the past 12 months.