Tourette Syndrome Clinical Trial
Official title:
A Randomized, Placebo-Controlled, Single-Dose Crossover Study of ABX-1431 HCl in Adult Patients With Tourette Syndrome (TS) and Chronic Motor Tic Disorder
The study will investigate the effects and the safety of a single-dose of ABX-1431 HCl on
tics and other symptoms of Tourette Syndrome.
During part 1 (periods 1 and 2) each patient will receive study drug once and placebo once.
Patients who complete part 1 with adequate clinical safety will be offered the option to
participate in part 2 (periods 3 and 4) and again willl receive study drug once and placebo
once where, in contrast to part 1, administration will take place with a standard high fat
meal.
This is a single dose, double-blind, randomized, placebo-controlled, cross-over study. This
study will assess the single dose effects of ABX-1431 HCl on tics and other symptoms of
Tourette Syndrome.
All patients will undergo a screening visit for enrollment criteria. Eligible patients will
be treated with a single dose of ABX-1431 HCl or placebo followed by efficacy, safety and
pharmacokinetics assessments. After a washout period of 1-3 weeks, patients will undergo
identical procedures with the other treatment.
Only patients who complete the first part of the study with adequate clinical safety will be
offered the option to participate in an additional two period crossover, where ABX-1431 HCl
or placebo is taken with a standard high fat meal. Again, efficacy, safety and
pharmacokinetics assessments will be done. After a washout period of 1-3 weeks, patients will
undergo identical procedures with the other treatment.
This study will enroll 20 patients with a diagnosis of Tourette Syndrome OR chronic motor tic
disorder.
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