Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents

Phase 2

Completed

Brief Summary: This study evaluates the effect of ecopipam tablets in children and adolescents in the treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam tablets, while the other half will receive matching placebo tablets

Detailed Description: Multicenter, placebo-controlled, double-blind, randomized, parallel-group, Phase 2b study in pediatric subjects (aged greater than equal to 6 to less than 18 years of age) with TS. Following a 28-day Screening period and Baseline visit, eligible subjects will be randomized 1:1 to receive either ecopipam hydrochloride (HCl) or matching placebo for a 12 week treatment period. Doses will be titrated up and down from target dose of 2 mg/kg/day. Follow Up visit will be conducted after the last dose of study medication.

Recruitment & Eligibility

Inclusion Criteria

≥ 6 and < 18 years of age
≥ 18 kg (~ 40 lbs.)
TS diagnosis and both motor and vocal tics that cause impairment with normal routines
Minimum score of 20 on the YGTSS-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

Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder)
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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching Placebo tablets taken orally in the evening
Ecopipam HCI 2 mg/kg/day	Ecopipam	Ecopipam HCl 12.5-, 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12	Baseline, Week 12	The YGTSS was a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were made along 5 different dimensions on a scale of 0=none to 5=severe for motor and vocal tics, each including number, frequency, intensity, complexity, and interference. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The total tic score (TTS) ranged from 0 (none) to 50 (severe) with higher score represent more severe symptoms. A negative change from baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12	Baseline, Week 12	Clinical Global Impression (CGI) scale was used to assess overall severity on a 7-point Likert scale consisted of 2 reliable and valid 7-item Likert scales used to assess severity and change in clinical symptoms. The CGI severity scale ranges from 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill subject. 1 = "normal, not ill at all" to 7 = "extremely ill." A negative change indicates improvement in the condition.

Locations (70): Harmonex Neuroscience Research
🇺🇸
Dothan, Alabama, United States
Phoenix Children's Hospital
🇺🇸
Phoenix, Arizona, United States
Advanced Research Center Inc.
🇺🇸
Anaheim, California, United States
UCLA
🇺🇸
Los Angeles, California, United States
PCSD-Feighner Research
🇺🇸
San Diego, California, United States
Syrentis Clinical Research
🇺🇸
Santa Ana, California, United States
Yale School of Medicine
🇺🇸
New Haven, Connecticut, United States
Sarkis Clinical Trials
🇺🇸
Gainesville, Florida, United States
Northwest Florida Clinical Research Group, LLC
🇺🇸
Gulf Breeze, Florida, United States
Research in Miami Inc.
🇺🇸
Hialeah, Florida, United States
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Harmonex Neuroscience Research
🇺🇸Dothan, Alabama, United States