Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
- Registration Number
- NCT05615220
- Lead Sponsor
- Emalex Biosciences Inc.
- Brief Summary
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.
- Detailed Description
Following a 28-day Screening period and Baseline visit, eligible subjects will be enrolled into the open-label Stabilization period comprised of a 4-week Titration phase to achieve a target steady-state dose of 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) followed by an 8-week open-label Maintenance phase. Responders to ecopipam will be randomized to ecopipam 1.8 mg/kg/day (2 mg/kg/day ecopipam HCl) or placebo in a 1:1 fashion and enter the double-blind Randomized-Withdrawal (R/WD) period at Week 12. During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
- ≥ 6 years of age
- ≥ 18 kg (~ 40 lbs.)
- TD diagnosis and both motor and vocal tics that cause impairment with normal routines
- Minimum score of 20 on the YGTSS-R Total Tic Score
- May not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline.
- Effective contraception during the study and 30 days after last study dose for sexually active subjects
- Previous exposure to ecopipam
- Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder)
- Unstable unstable medical illness or clinically significant lab abnormalities
- Risk of suicide
- Pregnant or lactating women
- Moderate to severe renal insufficiency
- Hepatic insufficiency
- Positive urine drug screen
- Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity Disorder
- Certain medications that would lead to drug interactions
- Recent behavioral therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo during R/WD Phase Ecopipam Hydrochloride Matching Placebo tablets during R/WD period taken orally in the evening. 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) Ecopipam Hydrochloride Ecopipam 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 mg tablets (containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively); 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) target dose; oral administration daily in evenings.
- Primary Outcome Measures
Name Time Method Yale Global Tic Severity Scale (YGTSS) Screening up to Week 24 Clinician-completed rating scale with score ranging from 0 to 50 (0=none to 50=severe)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (95)
Harmonex Neuroscience Research
🇺🇸Dothan, Alabama, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Advanced Research Center
🇺🇸Anaheim, California, United States
CenExel CIT-IE
🇺🇸Bellflower, California, United States
Cortica Site Network
🇺🇸Glendale, California, United States
Amnova Clinical Research
🇺🇸Irvine, California, United States
Cortica Site Network - San Rafael
🇺🇸San Rafael, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
University of Florida
🇺🇸Gainesville, Florida, United States
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