Ecopipam Treatment of Tourette's Syndrome in Subjects 7-17 Years

Completed · Phase 2 · Has a placebo group

Conditions studied: Tourette's Syndrome

In brief

Tourette's Syndrome is a neurological disease characterized by motor and vocal tics. It has been hypothesized that abnormal interactions of dopamine with its receptors may cause the tics. The purpose of this study is to test the hypothesis that a drug (ecopipam) that selectively blocks dopamine D1/D5 receptors can reduce the frequency and severity of the tics.

Key facts

Study ID

NCT02102698

Run by

Emalex Biosciences Inc.

People needed

40

Starts

2014-06-19

Expected to finish

2019-12-01

Last updated by the study team

2026-05-22

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects who have unstable medical illness or clinically significant abnormalities on laboratory tests, or ECG at Screening.
• Subjects with a major depressive episode in the past 2 years
• Subjects with a history of attempted suicide
• Subjects with clinically significant suicidality (based on the Columbia Suicide Rating Scale (C-SSRS)
• Subjects with a first-degree relative with a major depressive episode that resulted in any psychiatric hospitalization, or attempted/ completed suicide with the exception of a hospitalization for post-partum depression.
• Subjects with a history of seizures (excluding febrile seizures that occurred >2 years in the past)
• Subjects with a myocardial infarction within 6 months.
• Girls who are currently pregnant or lactating.
• Subjects who have a need for medication (other than ecopipam) with possible effects on TS symptoms (i.e., lithium, psychostimulants)
• Subjects who have a need for medications which would have unfavorable interactions with ecopipam, e.g., dopamine antagonists or agonists [including bupropion], tetrabenazine, or monoamine oxidase inhibitors.
• Subjects with a lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) Axis-I Disorders (SCID).
• Subjects with current or recent (past 3 months) DSM-IV substance abuse or dependence (with the exception of nicotine).
• Subjects with positive urine drug screen (cocaine, amphetamine, methamphetamine, tetrahydrocannabinol (THC), benzodiazepines, barbiturates, phencyclidine (PCP), opiates) at Screening. Subjects with urine positive only for benzodiazepines and/or marijuana (i.e., a user but not an abuser as based on DSM-IV criteria) may be eligible.
• Subjects who have had previous treatment with ecopipam.
• Subjects who have had treatment with:
• investigational medication within 3 months of starting study
• depot neuroleptics within 3 months of starting study
• other psychotropics with possible effects on TS symptoms (i.e., lithium, tetrabenazine) within 2 weeks prior to Screening.
• oral neuroleptics within 4 weeks
• selective serotonin reuptake inhibitors unless the dosage has been stable for a minimum of 4 weeks prior to study start and not prescribed to relieve the neurological signs of TS

Where it is running

• UCLA — Los Angeles, California, United States
• University of South Florida/Rothman Center for Neuropsychiatry — St. Petersburg, Florida, United States
• Emory University School Of Medicine — Atlanta, Georgia, United States
• University of Chicago Medical School — Chicago, Illinois, United States
• Children's Mercy Kansas City — Kansas City, Kansas, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Overlook Hospital — Summit, New Jersey, United States
• North Shore-Long Island Jewish Hosptial — Manhasset, New York, United States
• Weill Cornell Medical School — New York, New York, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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