Clinical Trials Directory

Trials / Completed

CompletedNCT03138421

Central Pain Study for ABX-1431

A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of ABX-1431 in Patients With Central Pain

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
9 (actual)
Sponsor
Abide Therapeutics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study will determine the safety and tolerability of ABX-1431 in patients with central pain when added on to background pain therapy. During the course of this study, each participant will take a daily dose of 20 mg of ABX-1431 or a matching placebo for approximately 7 to 9 weeks.

Detailed description

This is a double-blind, placebo-controlled crossover study, randomized, crossover study of ABX-1431 HCl as add-on therapy in the treatment of central neuropathic pain.The efficacy of ABX-1431 will also be assessed by the change in pain intensity scores using a numerical rating scale (NRS-11). All patients will undergo a screening visit for enrollment criteria. Eligible patients will be treated with daily medication for 7 to 9 weeks, which will include some treatment with placebo and some treatment with ABX-1431 HCl. Patients will use a web based application to record their daily average pain using a numerical rating scale (NRS-11). This study will enroll up to 32 patients with chronic central pain due to one of the four following diagnostic groups: Neuromyeliltis Optica Spectrum Disorder (NMOSD), longitudinally extensive transverse myelitis (LETM), Multiple Sclerosis (MS), and Transverse Myelitis (TM).

Conditions

Interventions

TypeNameDescription
DRUGABX-1431 HClABX-1431 HCl, capsules, 20 mg
DRUGPlaceboMatching placebo

Timeline

Start date
2017-08-01
Primary completion
2018-07-23
Completion
2018-07-24
First posted
2017-05-03
Last updated
2019-01-25

Locations

2 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03138421. Inclusion in this directory is not an endorsement.