A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SD-809 • SD-809 tablets taken once or twice daily for 8 weeks, includes a dose titration period and a maintenance period. |
Drug: SD-809
|
Outcome Measures
Primary Outcome Measures
- Safety [8 weeks]
Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal.
Secondary Outcome Measures
- 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]
Other Outcome Measures
- Pharmacokinetic parameters [8 weeks]
Eligibility Criteria
Criteria
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
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Willing to adhere to medication regimen and to comply with all procedures
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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
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Teva Investigational Site #101 | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Auspex Pharmaceuticals, Inc.
Investigators
- Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SD-809-C-17