A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS)
- Registration Number
- NCT02674321
- Lead Sponsor
- Auspex Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SD-809 SD-809 • SD-809 tablets taken once or twice daily for 8 weeks, includes a dose titration period and a maintenance period.
- Primary Outcome Measures
Name Time Method Safety 8 weeks Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS) Baseline, Weeks 2, 4 and 8 Change from Baseline in Impairment Score of the Yale Global Tic Severity Scale (YGTSS) Baseline, Weeks 2, 4, and 8 Change from Baseline in Global Severity Score of the Yale Global Tic Severity Scale (YGTSS) Baseline, Weeks 2, 4, and 8 Change from Baseline in Tourette Syndrome Clinical Global Impression Baseline, Weeks 2, 4, and 8 Patient Global Impression of Change (TS-PGIC) Weeks 2, 4, and 8
Trial Locations
- Locations (1)
Teva Investigational Site #101
🇺🇸Houston, Texas, United States