Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents
- Registration Number
- NCT04007991
- Lead Sponsor
- Emalex Biosciences Inc.
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- ≥ 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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.
Trial Locations
- Locations (70)
Harmonex Neuroscience Research
🇺🇸Dothan, Alabama, United States
Advanced Research Center Inc.
🇺🇸Anaheim, California, United States
Clinical Research Center of NJ
🇺🇸Voorhees, New Jersey, United States
Rare Disease Research, LLC
🇺🇸Atlanta, Georgia, United States
Dept. Child Adolescent Psychiatry Uni. Freiburg
🇩🇪Freiburg, Germany
Zentralinstitut fuer Seelische Gesundheit
🇩🇪Mannheim, Germany
Pharmakologisches Studienzentrum Chemnitz GmbH
🇩🇪Mittweida, Germany
Centrum Bada Klinicznych PI-House Sp. z o.o.
🇵🇱Gdansk, Poland
UCLA
🇺🇸Los Angeles, California, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Center for Psychiatry and Behavioral Medicine Inc.
🇺🇸Las Vegas, Nevada, United States
Quest Therapeutics of Avon Lake
🇺🇸Avon Lake, Ohio, United States
APG Research LLC
🇺🇸Orlando, Florida, United States
Houston Clinical Trials LLC
🇺🇸Bellaire, Texas, United States
Hapworth Research Inc.
🇺🇸New York, New York, United States
Movement Disorders Center
🇺🇸Saint Louis, Missouri, United States
Meridian Clinical Research
🇺🇸Savannah, Georgia, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Mood Disorders Consulting Medicine PLLC
🇺🇸New York, New York, United States
The University of Chicago Hospitals
🇺🇸Chicago, Illinois, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cincinnati Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
New York Neurology Associates P.C
🇺🇸New York, New York, United States
Helen DeVos Children's Hospital / Spectrum Health Medical Group
🇺🇸Wyoming, Michigan, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
North Star Medical Research LLC
🇺🇸Middleburg Heights, Ohio, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Noetic Psychiatry
🇺🇸Springville, Utah, United States
CHU Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Relaro Medical Trials
🇺🇸Dallas, Texas, United States
North Texas Clinical Trials
🇺🇸Fort Worth, Texas, United States
Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School
🇩🇪Hannover, Niedersachsen, Germany
Center for Pediatric Excellence
🇨🇦Ottawa, Ontario, Canada
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Gdanskie Centrum Zdrowia Sp z o.o.
🇵🇱Gdańsk, Poland
Centrum Medyczne Plejady
🇵🇱Krakow, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis
🇵🇱Katowice, Poland
Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie
🇵🇱Krakow, Poland
Med-Polonia Sp. z o. o.
🇵🇱Poznań, Poland
PCSD-Feighner Research
🇺🇸San Diego, California, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Access Clinical Trials, Inc.
🇺🇸Nashville, Tennessee, United States
Road Runner Research Ltd.
🇺🇸San Antonio, Texas, United States
MedBio Trials
🇺🇸North Miami, Florida, United States
AMR - Baber Research Inc.
🇺🇸Naperville, Illinois, United States
St. Charles Psychiatric Associates dba Midwest Research Group
🇺🇸Saint Charles, Missouri, United States
Pediatric Neurology, PA
🇺🇸Winter Park, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Neurobehavioral Medicine Group
🇺🇸Bloomfield Hills, Michigan, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
CHU Poitiers
🇫🇷Poitiers, France
Eastside Therapeutic Resource Inc dba Core Clinical Research
🇺🇸Everett, Washington, United States
Hopital Robert Debre
🇫🇷Paris, Ile De France, France
Research in Miami Inc.
🇺🇸Hialeah, Florida, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Northwest Florida Clinical Research Group, LLC
🇺🇸Gulf Breeze, Florida, United States
University of South Florida
🇺🇸Saint Petersburg, Florida, United States
The Kids Clinic Inc
🇨🇦Ajax, Ontario, Canada
University of Miami
🇺🇸Miami, Florida, United States
Alivation Research, LLC
🇺🇸Lincoln, Nebraska, United States
The NeuroCognitive Institute
🇺🇸Mount Arlington, New Jersey, United States
Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen
🇩🇪Muenchen, Bayern, Germany
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Pediatric Epilepsy and Neurology Specialists
🇺🇸Tampa, Florida, United States
Michigan Clinical Research Institute PC
🇺🇸Ann Arbor, Michigan, United States
Coastal Pediatric Research
🇺🇸Charleston, South Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States