To Evaluate ABX-1431 in Central Pain Patients
Research type
Research Study
Full title
A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of ABX-1431 in Patients with Central Pain
IRAS ID
219689
Contact name
Jacqueline Palace
Contact email
Sponsor organisation
Abide Therapeutics, Inc.
Eudract number
2016-004242-29
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
This study aims to evaluate an investigational drug, ABX-1431, for the treatment of chronic pain caused by inflammation in the central nervous system. Patients with ongoing pain caused by neuromyelitis optica spectrum disorders (NMOSD), idiopathic longitudinally extensive transverse myelitis (LETM), multiple sclerosis (MS) or transverse myelitis (TM) will be eligible to enroll. While these syndromes represent uncommon causes of central pain based on inflammatory causes, these patients have few effective therapeutic options to treat their pain. The unmet medical need, the rarity of patients, and the evidence supporting the endocannabinoid system as a treatment for central pain comprise the rationale for this study population.
ABX-1431 is a chemically-synthesized, potent and selective, orally available inhibitor of a metabolic enzyme that regulates the activity of the endocannabinoid system. It is being developed as a potential therapy for pain and inflammation.ABX-1431 has completed a first-in-human clinical study in Belgium. A PET brain imaging study with ABX-1431 has recently been completed in Belgium, and a functional MRI brain imaging study is ongoing in Oxford.
In this study, all patients will receive daily ABX-1431 on some days, and a matching daily placebo treatment on other days. Neither the patients nor the researchers conducting the study will know when each of these two possible treatments is being given. Patients will continue to take their routine pain medications throughout the study; ABX-1431 (or placebo) will be administered in addition to their baseline treatment. Patients will record the severity of their pain every day on an internet-connected device. In addition, patients will report their intake of pain medicines, and general state of well-being using questionnaires. Patients will also wear a wristband that will record their daily level of activity throughout the study.
Up to 32 adult male and female patients with ongoing chronic central pain caused by one of the four diagnostic groups mentioned above will be enrolled. The total study participation will be approximately 9 to 11 weeks, including 5 outpatient visits to the study site.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0007
Date of REC Opinion
1 Mar 2017
REC opinion
Further Information Favourable Opinion