Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: TEV-50717; Placebo
Intervention description: 6, 9, and 12 mg oral tablets; Placebo comparator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 228.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: adolescents; children

Summary:

      This is an otherwise open-label, single-arm study that includes a 2-week, double-blind,
      placebo controlled, randomized drug withdrawal period followed by a 3 week blinded
      maintenance or re-titration, and then a maintenance period. This study aims to evaluate the
      safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have
      previously completed participation in any of the parent studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is younger than 18 years of age on day 1

          -  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 is 18 years of age or older.

          -  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 a confirmed diagnosis of bipolar disorder, schizophrenia, or another
             psychotic disorder.

          -  Patient has clinically significant depression at screening or day 1. Note: Patients
             receiving antidepressant therapy may be enrolled if on a stable dose for at least 6
             weeks before screening.

          -  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 clinically significant obsessive-compulsive disorder (OCD) on day 1 that,
             in the opinion of the investigator, is the primary cause of impairment.

          -  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 for reduction of tics within 4 weeks of the
             screening visit.

          -  Patient has an unstable or serious medical illness at screening or day 1

          -  Patients with a history of torsade de pointes, congenital long QT syndrome,
             bradyarrhythmias, or uncompensated heart failure.

          -  Patient has received a monoamine oxidase inhibitor within 14 days of the day 1 visit.

          -  Patient has participated in an investigational drug or device study (with the
             exception of Study SD-809-C-17, Study TV50717-CNS-30046, or Study TV50717-CNS-30060)
             and received IMP/intervention within 30 days or 5 drug half-lives of day 1, whichever
             is longer.

          -  The patient is a pregnant or lactating female, or plans to become pregnant during the
             study.

          -  Patient has a history of, or acknowledges, alcohol-related disorder in the previous 12
             months -- Additional criteria apply, please contact the investigator for more
             information