Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults

Tourette Disorder Clinical Trial

— D1AMOND  

Official title:

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults With Tourette's Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615220
• Other study ID #: EBS-101-TD-301
• Status: Recruiting
• Phase: Phase 3
• Start date: January 31, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Emalex Biosciences Inc.
• Contact: Meredith M Miller
• Phone: 773 343 0671
• Email: mmiller[@]emalexbiosciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tourette Disorder
• Tourette Syndrome

Intervention

Drug:
• Ecopipam Hydrochloride
Selective dopamine D1 and D5 receptor antagonist

Locations

Country	Name	City	State
Bulgaria	Center Spectar-Plovdiv	Plovdiv
Bulgaria	ASMP-IP- d-r Kayryakova	Sofia	Lyulin 1
Bulgaria	Kalimat Medical Center_Sofia	Sofia
Bulgaria	DCC Mladost-M Varna	Varna
Canada	The Kids Clinic Inc	Ajax	Ontario
Canada	University of Calgary	Calgary	Alberta
Canada	Center for Pediatric Excellence	Ottawa	Ontario
Denmark	Borne og Ungeafdelingen	Herlev
France	CHU Grenoble Alpes - Hopital Couple Enfant	Grenoble
France	Hôpital Fondation Rothschild	Paris
France	CHU Strasbourg-Hopital de Hautepierre	Strasbourg
Germany	Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School	Hannover	Niedersachsen
Germany	Zentralinstitut fuer Seelische Gesundheit, Mannheim	Mannheim
Germany	Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen	Muenchen	Bayern
Hungary	Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza)	Budapest
Hungary	Vadaskert Gyermek- es Ifjusagpszichiatriai Korhaz es Szakambulancia	Budapest
Hungary	Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek	Szeged	Csongrád
Italy	Istituto Di Ricovero E Cura A Carattere Scientifico IRCCS Eugenio Medea	Bosisio Parini	LC
Italy	Azienda Ospedaliera Vittorio Emanuele Policlinico // Azienda Ospedaliera Policlinico San Marco	Catania
Italy	Ospedale Pediatrico Istituto Giannina Gaslini di Genova	Genova
Italy	IRCCS Istituto Neurologico Carlo Besta	Milano
Italy	Universita degli Studi di Napoli Federico II	Napoli
Poland	Gdanskie Centrum Zdrowia Sp z o.o.	Gdansk	Pomorskie
Poland	Wielospecjalistyczna Poradnia Lekarska Synapsis	Katowice	Silesia
Poland	Centrum Medyczne Plejady	Krakow
Poland	Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie	Krakow	Woj. Malopolskie
Romania	Spitalul Clinic de Psihiatrie Prof Dr Al. Obregia Bucureti	Dorobanti
Serbia	Clinic of Neurology and Psychiatry for Children and Adolescents	Belgrade
Serbia	Institute of Mental Health	Belgrade	Belgrad
Serbia	Clinical Centre Nis Center of Mental Health	Nis
Serbia	Clinical Center Vojvodina	Novi Sad
Spain	Hospital Universitario Fundacion Alcorcon HUFA	Alcorcón	Madrid
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitario Virgen del Rocío, C/Antonio Maura Montaner, s/n, edificio IBiS	Sevilla
Spain	Hospital Universitario Virgen Macarena Unidad de Investigacion Neurologia	Sevilla
United States	Advanced Research Center	Anaheim	California
United States	Michigan Clinical Research Institute PC	Ann Arbor	Michigan
United States	Atlanta Behavioral Research, LLC.	Atlanta	Georgia
United States	Rare Disease Research, LLC	Atlanta	Georgia
United States	Kennedy Krieger Institute	Baltimore	Maryland
United States	CenExel CIT-IE	Bellflower	California
United States	Neurobehavioral Medicine Group	Bloomfield Hills	Michigan
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Coastal Pediatric Research	Charleston	South Carolina
United States	OnSite Clinical Solutions LLC	Charlotte	North Carolina
United States	1725 W. Harrison St., Suite 755	Chicago	Illinois
United States	Chicago Research Center	Chicago	Illinois
United States	Lurie Children Hospital of Chicago	Chicago	Illinois
United States	The University of Chicago Hospitals	Chicago	Illinois
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio
United States	National Childrens Hospital - The Ohio State University	Columbus	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Harmonex Neuroscience Research	Dothan	Alabama
United States	Cedar Clinical Research	Draper	Utah
United States	Core Clinical Research	Everett	Washington
United States	University of Florida	Gainesville	Florida
United States	Cortica Site Network	Glendale	California
United States	NW FL Clinical Research Group, LLC	Gulf Breeze	Florida
United States	Research in Miami Inc	Hialeah	Florida
United States	Med Research Associates, Inc	Hollywood	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Texas Children's Hospital (TCH)	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Josephson-Wallack-Munshower Neurology	Indianapolis	Indiana
United States	Amnova Clinical Research	Irvine	California
United States	Emcrown Clinical Research	Jensen Beach	Florida
United States	The Childrens Mercy Hospital	Kansas City	Missouri
United States	Alivation Research	Lincoln	Nebraska
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	University of Louisville Research Foundation Inc.	Louisville	Kentucky
United States	Suburban Research Associates	Media	Pennsylvania
United States	Care Research Center	Miami	Florida
United States	Florida International Research Center	Miami	Florida
United States	IM Medical Research Center LLC	Miami	Florida
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	North Star Medical Research, LLC	Middleburg Heights	Ohio
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	Mount Sinai School of Medicine	New York	New York
United States	NYU Child Study Center	New York	New York
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	APG Research LLC	Orlando	Florida
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Providence Brain and Spine Institute	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	Midwest Research Group	Saint Charles	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of South Florida	Saint Petersburg	Florida
United States	Road Runner Research Ltd.	San Antonio	Texas
United States	Cortica Site Network - San Rafael	San Rafael	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Jedidiah Clinical Research	Tampa	Florida
United States	Pediatric Epilepsy and Neurology Specialists	Tampa	Florida
United States	Childrens National Hospital	Washington	District of Columbia
United States	Wake Forest Baptist Medical Center - PPDS	Winston-Salem	North Carolina
United States	Pediatric Neurology, PA	Winter Park	Florida
United States	Umass Chan Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Emalex Biosciences Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Denmark,  France,  Germany,  Hungary,  Italy,  Poland,  Romania,  Serbia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Global Tic Severity Scale (YGTSS)	Clinician-completed rating scale with score ranging from 0 to 50 (0=none to 50=severe)	Screening up to Week 24