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

Completed · Phase 2 · Has a placebo group

Conditions studied: Tourette Syndrome

In brief

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

Key facts

Study ID

NCT04007991

Run by

Emalex Biosciences Inc.

People needed

153

Starts

2019-06-28

Expected to finish

2021-09-23

Last updated by the study team

2023-10-04

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Harmonex Neuroscience Research — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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