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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Teva Investigational Site #101
Houston, Texas, United States
Safety
Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal.
Time frame: 8 weeks
Change from Baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS)
Time frame: Baseline, Weeks 2, 4 and 8
Change from Baseline in Impairment Score of the Yale Global Tic Severity Scale (YGTSS)
Time frame: Baseline, Weeks 2, 4, and 8
Change from Baseline in Global Severity Score of the Yale Global Tic Severity Scale (YGTSS)
Time frame: Baseline, Weeks 2, 4, and 8
Change from Baseline in Tourette Syndrome Clinical Global Impression
Time frame: Baseline, Weeks 2, 4, and 8
Patient Global Impression of Change (TS-PGIC)
Time frame: Weeks 2, 4, and 8
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