Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
Purpose
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.
Condition
- Tourette Disorder
Eligibility
- Eligible Ages
- Over 6 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥ 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
Exclusion Criteria
- 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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- This is a multicenter study which includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- This includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) |
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. |
|
|
Placebo Comparator Placebo during R/WD Phase |
Matching Placebo tablets during R/WD period taken orally in the evening. |
|
Recruiting Locations
Nashville, Tennessee 37232-7610
More Details
- Status
- Recruiting
- Sponsor
- Emalex Biosciences Inc.
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.