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 |
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.
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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