TOURETTE SYNDROME
Conditions
Keywords
Tourette Syndrome, adolescents
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.
Interventions
DRUGSD-809
Sponsors
Auspex Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 8 weeks | Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal. |
Secondary
| Measure | Time frame |
|---|---|
| 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 Tourette Syndrome Clinical Global Impression | Baseline, Weeks 2, 4, and 8 |
| Patient Global Impression of Change (TS-PGIC) | 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 |
Other
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters | 8 weeks |
Countries
United States
Outcome results
None listed