A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS)

Inclusion Criteria:

- 12 to 18 years of age, inclusive, at Screening.

- Patient has a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
(DSM-V) diagnosis of Tourette Syndrome and has manifested motor and phonic tics
within 3 months before the Screening visit

- Patient has total tic score of ≥19 on the YGTSS

- Tic severity and frequency has been stable for at least 2 weeks before the Screening
visit

- Willing to adhere to medication regimen and to comply with all procedures

- Patient is in good general health, as indicated by medical and psychiatric history
and physical examination

- Patient and parent/guardian have provided written, informed consent (and written
assent, as appropriate)

- Female patients of childbearing potential agree to use an acceptable method of
contraception

- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

- Patient has a serious untreated or undertreated psychiatric illness

- Patient has a history of suicidal ideation or behavior

- Patient has received tetrabenazine, neuroleptics, benzodiazepines, topiramate,
dopamine receptor antagonists within 14 days of Screening or Baseline; or botulinum
toxin within 3 months of Screening or Baseline

- Patient is being treated with deep brain stimulation for control of tics

- Patient has a progressive or degenerative neurological disorder or a structural
disorder of the brain

- Patient has participated in an investigational drug or device trial within 30 days of
Screening

- Patient is pregnant or breastfeeding at Screening or Baseline

- Patient has a history of alcohol or substance abuse in the previous 12 months, as
defined in the DSM-V

- Additional criteria apply, please contact the investigator for more information