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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CITrials
Riverside, California, United States
RECRUITINGUniversity of California Riverside School of Medicine
Riverside, California, United States
NOT_YET_RECRUITINGChange 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.
Time frame: This scale is completed on Visit 1/screening and Visit 5/week 8.
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.
Time frame: This scale is completed on Visit 1/screening, Visit 2/baseline, Visit 3/week 2, and Visit 5/week 8.
Subjective Stuttering Scale (SSS)
Time frame: This scale is completed on Visit 2/baseline and Visit 5/week 8.
Overall Assessment of the Speaker's Experience of Stuttering (OASES)
Time frame: This scale is completed on Visit 2/baseline and Visit 5/week 8.
Montgomery Asberg Depression Rating Scale (MADRS)
An observer-rated depression scale
Time frame: 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
Time frame: This scale is completed on Visit 1/screening, Visit 5/week 8.
Abnormal Involuntary Movement Scale (AIMS)
Time frame: This scale is completed on Visit 1/screening, Visit 5/week 8.
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 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)
Time frame: This scale is completed on Visit 1/screening, Visit 5/week 8.