A Study to Evaluate the Safety and Tolerability of Long-term Therapy With TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

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