Status and phase
Conditions
Treatments
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
Sex
Ages
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
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
Primary purpose
Allocation
Interventional model
Masking
23 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal