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

Tourette Syndrome Clinical Trial

— D1AMOND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007991
• Other study ID #: EBS-101-CL-001
• Status: Completed
• Phase: Phase 2
• Start date: June 28, 2019
• Est. completion date: September 23, 2021

Study information

• Verified date: September 2023
• Source: Emalex Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

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

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Drug:
• Ecopipam
Ecopipam HCI tablets administered PO to establish 2 mg/kg/day
• Placebo
Matching Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Emalex Biosciences Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at 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.	Baseline, Week 12