Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents
D1AMOND
Multicenter, Placebo-Controlled, Double-Blind, Randomized, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Ecopipam in Children and Adolescents With Tourette's Syndrome
1 other identifier
interventional
153
5 countries
70
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2019
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2019
CompletedFirst Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2021
CompletedResults Posted
Study results publicly available
October 4, 2023
CompletedOctober 4, 2023
September 1, 2023
2.2 years
July 2, 2019
September 8, 2023
September 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at 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.
Baseline, Week 12
Secondary Outcomes (1)
Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12
Baseline, Week 12
Study Arms (2)
Ecopipam HCI 2 mg/kg/day
EXPERIMENTALEcopipam HCl 12.5-, 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings
Placebo
PLACEBO COMPARATORMatching Placebo tablets taken orally in the evening
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
Harmonex Neuroscience Research
Dothan, Alabama, 36303, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Advanced Research Center Inc.
Anaheim, California, 92805, United States
UCLA
Los Angeles, California, 90095, United States
PCSD-Feighner Research
San Diego, California, 92108, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Yale School of Medicine
New Haven, Connecticut, 06519, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Northwest Florida Clinical Research Group, LLC
Gulf Breeze, Florida, 32561, United States
Research in Miami Inc.
Hialeah, Florida, 33013, United States
University of Miami
Miami, Florida, 33136, United States
MedBio Trials
North Miami, Florida, 33180, United States
APG Research LLC
Orlando, Florida, 32803, United States
University of South Florida
St. Petersburg, Florida, 33701-4825, United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, 33609-4181, United States
Pediatric Neurology, PA
Winter Park, Florida, 32789, United States
Rare Disease Research, LLC
Atlanta, Georgia, 30318, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Rush University Medical Center
Chicago, Illinois, 60612-3841, United States
The University of Chicago Hospitals
Chicago, Illinois, 60637-1447, United States
AMR - Baber Research Inc.
Naperville, Illinois, 60563-6510, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, 48105, United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302-1952, United States
Helen DeVos Children's Hospital / Spectrum Health Medical Group
Wyoming, Michigan, 49418, United States
St. Charles Psychiatric Associates dba Midwest Research Group
Saint Charles, Missouri, 63304, United States
Movement Disorders Center
St Louis, Missouri, 63110-1093, United States
Alivation Research, LLC
Lincoln, Nebraska, 68526, United States
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, 89128, United States
The NeuroCognitive Institute
Mount Arlington, New Jersey, 07856, United States
Clinical Research Center of NJ
Voorhees Township, New Jersey, 08043-1910, United States
New York Neurology Associates P.C
New York, New York, 10003, United States
Hapworth Research Inc.
New York, New York, 10019, United States
Mount Sinai School of Medicine
New York, New York, 10029-6504, United States
Mood Disorders Consulting Medicine PLLC
New York, New York, 10036, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Quest Therapeutics of Avon Lake
Avon Lake, Ohio, 44012-1004, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229-3026, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
North Star Medical Research LLC
Middleburg Heights, Ohio, 44130, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Coastal Pediatric Research
Charleston, South Carolina, 29414, United States
Access Clinical Trials, Inc.
Nashville, Tennessee, 37203-6502, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-0028, United States
Houston Clinical Trials LLC
Bellaire, Texas, 77401, United States
Relaro Medical Trials
Dallas, Texas, 75243, United States
North Texas Clinical Trials
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Road Runner Research Ltd.
San Antonio, Texas, 78249-3539, United States
Noetic Psychiatry
Springville, Utah, 84663, United States
University of Virginia
Charlottesville, Virginia, 22908-0829, United States
Eastside Therapeutic Resource Inc dba Core Clinical Research
Everett, Washington, 98201-4077, United States
The Kids Clinic Inc
Ajax, Ontario, L1Z 0M1, Canada
Center for Pediatric Excellence
Ottawa, Ontario, K2G 1W2, Canada
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
CHU Poitiers
Poitiers, 86021, France
Hopital Robert Debre
Paris, Île-de-France Region, 75019, France
Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen
Munich, Bavaria, 80336, Germany
Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School
Hanover, Lower Saxony, 30625, Germany
Dept. Child Adolescent Psychiatry Uni. Freiburg
Freiburg im Breisgau, 79104, Germany
Zentralinstitut fuer Seelische Gesundheit
Mannheim, 68159, Germany
Pharmakologisches Studienzentrum Chemnitz GmbH
Mittweida, 09648, Germany
Gdanskie Centrum Zdrowia Sp z o.o.
Gdansk, 80-542, Poland
Centrum Bada Klinicznych PI-House Sp. z o.o.
Gdansk, 80-546, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis
Katowice, 40-123, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie
Krakow, 31-503, Poland
Med-Polonia Sp. z o. o.
Poznan, 60-693, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical contact
- Organization
- Emalex Biosciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2019
First Posted
July 5, 2019
Study Start
June 28, 2019
Primary Completion
September 23, 2021
Study Completion
September 23, 2021
Last Updated
October 4, 2023
Results First Posted
October 4, 2023
Record last verified: 2023-09