Childhood-onset Fluency Disorder, Communication Disorder, Language Disorders, Speech Disorders, Stuttering, Adult
Conditions
Keywords
stuttering, childhood onset fluency disorder, ecopipam
Brief 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.
Interventions
DRUGEcopipam 50mg
DRUGEcopipam 100mg
Sponsors
University of California Riverisde School of Medicine
Gerald Maguire, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Stuttering Severity Instrument Version IV (SSI-IV) | This scale is completed on Visit 1/screening and Visit 5/week 8. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression Scale-Severity (CGI-S) | This scale is completed on Visit 1/screening, Visit 2/baseline, Visit 3/week 2, and Visit 5/week 8. | 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. |
| 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) | This scale is completed on Visit 2/baseline, Visit 3/week 2, Visit 4/week 4 and Visit 5/week 8. | An observer-rated depression scale |
| Barnes Akathisia Scale (BAS) | This scale is completed on Visit 1/screening, Visit 5/week 8. | measures how restless the subject is during the examination |
| 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. | — |
Countries
United States
Outcome results
None listed