This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 exploratory study in adult subjects with childhood onset fluency disorder.
At the Baseline visit, eligible subjects will be randomized 1:1 to receive either a target steady-state dose of ecopipam HCl \~2 mg/kg/day or matching placebo for a 12-week Treatment Period consisting of a 4-week Titration Phase followed by an 8-week Maintenance Phase. Subjects will return to the clinic at 4, 8, and 12 weeks after Randomization and Follow-up visits 7 and 14 days after completing the Treatment Period or Early Discontinuation. Efficacy assessments will be conducted at Weeks 4, 8, and 12 and safety assessments will be conducted at all visits. Subjects will have adverse events and other safety parameters assessed by phone or video conference at Weeks 2, 6 and 10 and 30 days after the last study drug administration. Signs or symptoms of withdrawal, abuse, and dependence will be monitored throughout the study. At the end of the Treatment Period or Early Discontinuation, subjects will taper study drug by 25 mg/day until off study drug, for up to 1 week.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
68
UC Riverside
Riverside, California, United States
CI Trials
Santa Ana, California, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, United States
Clinical Neuroscience Solutions Inc
Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12
Measures stuttering severity in children and adults
Time frame: 12 weeks
Clinical Global Impression - Severity (CGI-S) baseline to Week 12
Rates the severity of the subject's illness at the time of assessment, relative to the the clinician's past experience with patients who have the same diagnosis.
Time frame: 12 weeks
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Orlando, Florida, United States
Institute For Advanced Medical Research
Atlanta, Georgia, United States
Social Psychiatry Research Institute
Prairie Village, Kansas, United States
Michigan State University
East Lansing, Michigan, United States
Social Psychiatry Research Institute
Brooklyn, New York, United States
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, United States