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

Phase 2 Completed 50 enrolled Abide Therapeutics BASi (Bioanalytical Systems, Inc.) · collab CogState Ltd. · collab FGK Clinical Research GmbH · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Outcome

Missed primary endpoint

paper the mean (95% CI) treatment difference at week 8 of 3.0 (0.1, 5.9) (P = 0.043) favored placebo. PMID 34117788 ↗

paper There was no evidence that Lu AG06466 has efficacy in suppressing tics. PMID 34117788 ↗

Publications

Muller-Vahl KR, Fremer C, Beals C, Ivkovic J, Loft H, Schindler C. Monoacylglycerol Lipase Inhibition in Tourette Syndrome: A 12-Week, Randomized, Controlled Study. Mov Disord. 2021 Oct;36(10):2413-2418. doi: 10.1002/mds.28681. Epub 2021 Jun 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABX-1431	Small molecule	10 mg	Oral