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

NCT03058562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-11-06

No results posted yet for this study

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.

Conditions

  • Tourette Syndrome
  • Chronic Motor Tic Disorder

Interventions

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

Sponsors & Collaborators

  • Abide Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chan Beals · Abide Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2017-10-04
Completion
2017-10-04

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03058562 on ClinicalTrials.gov