Alternatives for Reducing Tics in TS: A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents.



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:6 - 16
Updated:3/7/2019
Start Date:February 21, 2018
End Date:August 28, 2019
Contact:Teva U.S. Medical Information
Email:USMedInfo@tevapharm.com
Phone:1-888-743-9887

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A Randomized, Double-blind, Placebo-controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

This is a study to evaluate the efficacy and safety of deutetrabenazine (TEV-50717) tablets
for the reduction of motor and phonic tics associated with TS in children and adolescents 6
through 16 years of age.


Inclusion Criteria:

- Patient is 6 to 16 years of age, inclusive

- Patient weighs at least 44 pounds (20 kg)

- The patient's active tics are causing distress or impairment

- Patient is able to swallow study medication whole

- Patient is in good general health

- Women/girls of childbearing potential whose male partners are of childbearing
potential must use contraception for the duration of the study

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

Exclusion Criteria:

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

- Patient has a confirmed diagnosis of bipolar disorder, schizophrenia, or another
psychotic 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 received comprehensive behavioral intervention for tics (CBIT) for TS or
cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) within 4
weeks of screening.

- Patient has an unstable or serious medical illness at screening or baseline.

- Patient is pregnant or breastfeeding.

- Additional criteria apply, please contact the investigator for more information.
We found this trial at
18
sites
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Orem, UT
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Ajax,
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Atlanta, GA
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Dallas, TX
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Dothan, Alabama 36303
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Dothan, AL
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Houston, Texas 77054
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Houston, TX
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Oklahoma City, Oklahoma
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Oklahoma City, OK
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Orlando, FL
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Petersburg, Virginia 23805
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Petersburg, VA
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Rochester, New York
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from
Rochester, NY
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Rogers, Arkansas 72758
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Rogers, AR
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Sacramento, California
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Sacramento, CA
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Saint Charles, Missouri 63304
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Saint Charles, MO
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Saint Petersburg, Florida
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Saint Petersburg, FL
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San Antonio, Texas
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San Antonio, TX
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San Diego, California
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San Diego, CA
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Sun City, Arizona
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Sun City, AZ
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Voorhees, New Jersey 08043
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from
Voorhees, NJ
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