A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:6 - 16
Updated:3/14/2019
Start Date:June 22, 2018
End Date:December 9, 2019
Contact:Teva U.S. Medical Information
Email:USMedInfo@tevapharm.com
Phone:1-888-743-9887

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A Well-Controlled, Fixed-Dose Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tics Associated With Tourette Syndrome

Standard placebo-controlled, double-blind study design (TEV-50717 [low dose and high dose]
vs. placebo in a 1:1:1 ratio) was chosen to determine whether IMP treatment results in a
statistically significant effect on the tics in patients with TS.


Inclusion Criteria:

- Patient weighs at least 44 pounds (20 kg) at baseline.

- Patient meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
(DSM-5™) diagnostic criteria for TS and, in the opinion of the investigator, patient,
and parent/legal guardian, the patient's active tics are causing distress or
impairment.

- Patient has a TTS of 20 or higher on the YGTSS at screening and baseline.

- Patient is able to swallow study medication whole.

- -Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

- Patient has a neurologic disorder other than TS that could obscure the evaluation of
tics.

- The patient's predominant movement disorder is stereotypy (coordinated movements that
repeat continually and identically) associated with autism spectrum disorder.

- Patient has clinically significant depression at screening or baseline.

- Patient has a history of suicidal intent or related behaviors within 2 years of
screening

- Patient has a history of a previous actual, interrupted, or aborted suicide attempt.

- Patient has a first-degree relative who has completed suicide.

- Patient has a confirmed diagnosis of bipolar disorder, schizophrenia, or another
psychotic disorder.

- Patient has received Comprehensive Behavioral Intervention for Tics for TS or
Cognitive Behavioral Therapy for OCD within 4 weeks of screening.

- Patient has received treatment with deep brain stimulation, transmagnetic stimulation,
or transcranial direct current stimulation within 4 weeks of the screening visit for
reduction of tics.

- Patient has a history of torsades de pointes, congenital long QT syndrome,
bradyarrhythmias, or uncompensated heart failure.

- Patient has participated in an investigational drug or device study and received
IMP/intervention within 30 days or 5 drug half-lives of baseline, whichever is longer.

- Patient is a pregnant or lactating female, or plans to be pregnant during the study.

- -Additional criteria apply, please contact the investigator for more information
We found this trial at
16
sites
Fort Worth, Texas
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Ann Arbor, Michigan
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Buenos Aires,
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Charleston, South Carolina
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Charleston, SC
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Chicago, Illinois
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Chicago, IL
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Cordova, Tennessee
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Cordova, TN
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Everett, Washington
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Everett, WA
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Gainesville, Florida
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Gainesville, FL
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Gulf Breeze, Florida 32561
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Indianapolis, Indiana
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Indianapolis, IN
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Louisville, Kentucky 40291
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Louisville, KY
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Miami, FL
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New York, New York
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New York, NY
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Orlando, FL
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Rockville, Maryland
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Rockville, MD
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Saint Louis, Missouri
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Saint Louis, MO
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