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

NCT ID: NCT04007991

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-28
• Study Completion Date: 2021-09-23

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.

Conditions

Tourette Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ecopipam HCI 2 mg/kg/day

Ecopipam HCl 12.5-, 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings

Group Type: EXPERIMENTAL

Ecopipam

Intervention Type: DRUG

Ecopipam HCI tablets administered PO to establish 2 mg/kg/day

Placebo

Matching Placebo tablets taken orally in the evening

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo

Interventions

Ecopipam

Ecopipam HCI tablets administered PO to establish 2 mg/kg/day

Intervention Type: DRUG

Placebo

Matching Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emalex Biosciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

University of Miami

Miami, Florida, United States

MedBio Trials

North Miami, Florida, United States

APG Research LLC

Orlando, Florida, United States

University of South Florida

St. Petersburg, Florida, United States

Pediatric Epilepsy and Neurology Specialists

Tampa, Florida, United States

Pediatric Neurology, PA

Winter Park, Florida, United States

Rare Disease Research, LLC

Atlanta, Georgia, United States

Meridian Clinical Research

Savannah, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

The University of Chicago Hospitals

Chicago, Illinois, United States

AMR - Baber Research Inc.

Naperville, Illinois, United States

Psychiatric Associates

Overland Park, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Michigan Clinical Research Institute PC

Ann Arbor, Michigan, United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States

Helen DeVos Children's Hospital / Spectrum Health Medical Group

Wyoming, Michigan, United States

St. Charles Psychiatric Associates dba Midwest Research Group

Saint Charles, Missouri, United States

Movement Disorders Center

St Louis, Missouri, United States

Alivation Research, LLC

Lincoln, Nebraska, United States

Center for Psychiatry and Behavioral Medicine Inc.

Las Vegas, Nevada, United States

The NeuroCognitive Institute

Mount Arlington, New Jersey, United States

Clinical Research Center of NJ

Voorhees Township, New Jersey, United States

New York Neurology Associates P.C

New York, New York, United States

Hapworth Research Inc.

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Mood Disorders Consulting Medicine PLLC

New York, New York, United States

Finger Lakes Clinical Research

Rochester, New York, United States

Quest Therapeutics of Avon Lake

Avon Lake, Ohio, United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

North Star Medical Research LLC

Middleburg Heights, Ohio, United States

Suburban Research Associates

Media, Pennsylvania, United States

Coastal Pediatric Research

Charleston, South Carolina, United States

Access Clinical Trials, Inc.

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Houston Clinical Trials LLC

Bellaire, Texas, United States

Relaro Medical Trials

Dallas, Texas, United States

North Texas Clinical Trials

Fort Worth, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Road Runner Research Ltd.

San Antonio, Texas, United States

Noetic Psychiatry

Springville, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Eastside Therapeutic Resource Inc dba Core Clinical Research

Everett, Washington, United States

The Kids Clinic Inc

Ajax, Ontario, Canada

Center for Pediatric Excellence

Ottawa, Ontario, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

CHU Poitiers

Poitiers, , France

Hopital Robert Debre

Paris, Île-de-France Region, France

Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen

Munich, Bavaria, Germany

Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School

Hanover, Lower Saxony, Germany

Dept. Child Adolescent Psychiatry Uni. Freiburg

Freiburg im Breisgau, , Germany

Zentralinstitut fuer Seelische Gesundheit

Mannheim, , Germany

Pharmakologisches Studienzentrum Chemnitz GmbH

Mittweida, , Germany

Gdanskie Centrum Zdrowia Sp z o.o.

Gdansk, , Poland

Centrum Bada Klinicznych PI-House 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, , Poland

Countries

United States; Canada; France; Germany; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

EBS-101-CL-001

Identifier Type: -

Identifier Source: org_study_id