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

Auspex Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

TOURETTE SYNDROME

Treatments

Drug: SD-809

Study type

Interventional

Funder types

Industry

Identifiers

NCT02674321

SD-809-C-17

Details and patient eligibility

About

The purpose of this study is to evaluate safety, tolerability and preliminary efficacy of SD-809 in the treatment of motor and phonic tics of Tourette Syndrome and to evaluate the pharmacokinetic of SD-809 and its metabolites.

Enrollment

23 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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