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

Completed · Phase 3 · Has a placebo group

Conditions studied: Tourette Disorder

In brief

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 a double-blind, placebo-controlled, randomized withdrawal period.

Key facts

Study ID

NCT05615220

Run by

Emalex Biosciences Inc.

People needed

216

Starts

2023-01-31

Expected to finish

2025-02-04

Last updated by the study team

2026-06-12

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• Previous exposure to ecopipam
• 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

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Advanced Research Center — Anaheim, California, United States
• CenExel CIT-IE — Bellflower, California, United States
• Cortica Site Network — Glendale, California, United States
• Amnova Clinical Research — Irvine, California, United States
• Cortica Site Network - San Rafael — San Rafael, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• NW FL Clinical Research Group, LLC — Gulf Breeze, Florida, United States
• Research in Miami Inc — Hialeah, Florida, United States
• Emcrown Clinical Research — Jensen Beach, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Florida International Research Center — Miami, Florida, United States
• Care Research Center — Miami, Florida, United States
• Medical Research Group of Central Florida — Orange City, 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
• Jedidiah Clinical Research — Tampa, Florida, United States
• Pediatric Neurology, PA — Winter Park, Florida, United States
• Advanced Discovery Research, LLC — Atlanta, Georgia, United States
• Rare Disease Research, LLC — Atlanta, Georgia, United States
• Atlanta Behavioral Research, LLC. — Atlanta, Georgia, United States
• Harmonex Neuroscience Research — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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