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

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label Study to Evaluate the Efficacy and Tolerability of Ecopipam in Adults With Childhood Onset Fluency Disorder (Stuttering).

Conditions
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Stuttering, Adult, Childhood-onset Fluency Disorder, Speech Disorders, Language Disorders, Communication Disorder

Intervention / Treatment
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* Drug: Ecopipam 50mg
* Drug: Ecopipam 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects can be enrolled in the study only if they meet all of the following 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: Subjects will be excluded from the study for any of the following reasons: 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. Subjects with Parkinson's dementia or other degenerative neurologic illness. Suffer from irregular heart rate or seizures Subjects who are pregnant or nursing an infant. Subject with a MADRS ≥ 14 Breastfeeding a child during the course of the study or for one month following completion It is the investigator's opinion that the subject poses a significant suicide risk by the following criteria: It is the investigator's opinion that the subject may be at risk of suicide. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ecopipam 50mg<br>50mg of ecopipam at bedtime for the first two weeks. If there is deemed improvement by the investigator, the subject will remain on the same dose. If there is no improvement, then the subjects' dose will be increased to 100mg at bedtime beginning on day 14. | Drug: Ecopipam 50mg<br> <br> Drug: Ecopipam 100mg<br> <br> |
| Experimental: Ecopipam 100mg<br>If there is no improvement, then the subjects' dose will be increased to 100mg at bedtime beginning on day 14. | Drug: Ecopipam 50mg<br> <br> Drug: Ecopipam 100mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Stuttering Severity Instrument Version IV (SSI-IV) | This is an objective measure of stuttering in which it captures verbal samples of five minutes speaking during a conversation and 5 minutes of reading a passage. | This scale is completed on Visit 1/screening and Visit 5/week 8. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Scale-Severity (CGI-S) | This is an evaluation of the patient by the investigator as to whether or not the subjects has improved, remained the same, or worsened while in the study. | This scale is completed on Visit 1/screening, Visit 2/baseline, Visit 3/week 2, and Visit 5/week 8. | 
| Subjective Stuttering Scale (SSS) |  | This scale is completed on Visit 2/baseline and Visit 5/week 8. | 
| Overall Assessment of the Speaker's Experience of Stuttering (OASES) |  | This scale is completed on Visit 2/baseline and Visit 5/week 8. | 
| Montgomery Asberg Depression Rating Scale (MADRS) | An observer-rated depression scale | This scale is completed on Visit 2/baseline, Visit 3/week 2, Visit 4/week 4 and Visit 5/week 8. | 
| Barnes Akathisia Scale (BAS) | measures how restless the subject is during the examination | This scale is completed on Visit 1/screening, Visit 5/week 8. | 
| Abnormal Involuntary Movement Scale (AIMS) |  | This scale is completed on Visit 1/screening, Visit 5/week 8. | 
| Columbia-Suicide Severity Rating Scale (C-SSRS) |  | This scale is completed on Visit 1/screening, Visit 2/baseline, Visit 3/week 2, Visit 4/week 4 and Visit 5/week 8. | 
| Simpson Angus Scale (SAS) |  | This scale is completed on Visit 1/screening, Visit 5/week 8. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stuttering, childhood onset fluency disorder, ecopipam