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

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

ArmDescriptionAssigned 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.
  • Drug: Ecopipam Hydrochloride
    Selective dopamine D1 and D5 receptor antagonist
Placebo Comparator
Placebo during R/WD Phase
Matching Placebo tablets during R/WD period taken orally in the evening.
  • Drug: Ecopipam Hydrochloride
    Selective dopamine D1 and D5 receptor antagonist

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Sam Nick Russo, MD
713-500-5511
Sam.N.Russo@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
Emalex Biosciences Inc.

Study Contact

Meredith M Miller
773 343 0671
mmiller@emalexbiosciences.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.