A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: TEV-50717; Placebo
Intervention description: 6-, 9-, 12-, 15-, and 18 mg oral tablets; Placebo matched to TEV-50717 tablets will be taken BID.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      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 study drug treatment results in
      a statistically significant effect on the tics in participants with TS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant weighs at least 44 pounds (20 kg) at baseline.

          -  Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth
             Edition (DSM-5™) diagnostic criteria for TS and, in the opinion of the investigator,
             participant, and parent/legal guardian, the participant's active tics are causing
             distress or impairment.

          -  Participant has a TTS of 20 or higher on the YGTSS at screening and baseline.

          -  Participant is able to swallow study medication whole.

          -  -Additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  Participant has a neurologic disorder other than TS that could obscure the evaluation
             of tics.

          -  The participant 's predominant movement disorder is stereotypy (coordinated movements
             that repeat continually and identically) associated with autism spectrum disorder.

          -  Participant has clinically significant depression at screening or baseline.

          -  Participant has a history of suicidal intent or related behaviors within 2 years of
             screening

          -  Participant has a history of a previous actual, interrupted, or aborted suicide
             attempt.

          -  Participant has a first-degree relative who has completed suicide.

          -  Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another
             psychotic disorder.

          -  Participant has received Comprehensive Behavioral Intervention for Tics for TS or
             Cognitive Behavioral Therapy for obsessive-compulsive disorder (OCD) within 4 weeks of
             screening.

          -  Participant 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.

          -  Participant has a history of torsades de pointes, congenital long QT syndrome,
             bradyarrhythmias, or uncompensated heart failure.

          -  Participant has participated in an investigational drug or device study and received
             investigational medicinal product (IMP)/intervention within 30 days or 5 drug
             half-lives of baseline, whichever is longer.

          -  Participant is a pregnant or lactating female, or plans to be pregnant during the
             study.

          -  -Additional criteria apply, please contact the investigator for more information