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 |
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.
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
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