NCT03625453

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

A Randomized, Placebo-Controlled Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Abide Therapeutics · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

ABX-1431 is a potent and selective, orally available, irreversible inhibitor of monoacylglycerol lipase, a metabolic enzyme that regulates the activity of the endogenous cannabinoid (endocannabinoid) system. It is being developed as a potential first-in-class compound for the treatment of Tourette Syndrome. This study will assess the safety, tolerability, and effect on tics ABX-1431 in adults with Tourette Syndrome or chronic motor tic disorder in an 8-week study. It is a two-part study. Part 1 is a double-blind, randomized, placebo-controlled study of ABX-1431 at two target dose levels. Part 2 is an optional, open-label, non-randomized study of ABX-1431. Patients will participate in the main study (Part 1) for approximately 10 to 14 weeks (up to 30-day screening period; 56-day treatment period; 14-day follow-up period). For patients who choose to participate in Part 2, there is a period of up to 4 weeks between the last study visit in Part 1 and first study visit in Part 2. Patients who choose to enter Part 2 will be treated with open-label ABX-1431 for an additional 6 weeks (28-day treatment period; 14-day follow-up period).

Conditions

• Tourette Syndrome
• Motor Tic Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-10-15
• Primary completion: 2020-01-20
• Completion: 2020-01-20
• First posted: 2018-08-10
• Last updated: 2020-04-08

Locations

8 sites across 3 countries: Germany, Poland, Spain