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Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder

NCT03625453 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-04-08

No results posted yet for this study

Summary

Two-part study consisting of a double-blind, randomized, placebo-controlled, study at two target dose levels (Part 1) and an open-label, non-randomized study (Part 2) to determine the efficacy of ABX-1431 in treating adult patients with Tourette syndrome or Chronic Motor Tic Disorder as measured by the change from baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) compared with placebo.

Conditions

  • Tourette Syndrome
  • Motor Tic Disorder

Interventions

DRUG

ABX-1431

Part 1: 8 weeks with daily administration; Patients who choose to enter Part 2: additional 4 weeks with daily administration

DRUG

Placebo

Part 1: 8 weeks with daily administration

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • BASi (Bioanalytical Systems, Inc.)

    collaborator INDUSTRY

  • CogState Ltd.

    collaborator INDUSTRY

  • Abide Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chan Beals, M.D., Ph.D. · Abide Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2020-01-20
Completion
2020-01-20

Countries

  • Germany
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT03625453 on ClinicalTrials.gov