NCT03058562

A Study to Evaluate the Effects of ABX-1431 on Patients With Tourette Syndrome

A Randomized, Placebo-Controlled, Single-Dose Crossover Study of ABX-1431 HCl in Adult Patients With Tourette Syndrome (TS) and Chronic Motor Tic Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Abide Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Tourette Syndrome
• Chronic Motor Tic Disorder

Interventions

Type	Name	Description
DRUG	ABX-1431	ABX-1431, capsules, 40 mg in the fasting state
DRUG	Placebo Comparator	Matching Placebo
DRUG	ABX-1431	ABX-1431, capsules, 20 mg with a high fat meal

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-10-04
• Completion: 2017-10-04
• First posted: 2017-02-23
• Last updated: 2017-11-06

Locations

1 site across 1 country: Germany