Clinical Trials Directory

Trials / Completed

CompletedNCT03447756

Titration Study of ABX-1431

A Randomized, Placebo-Controlled, Optimized Titration Study of ABX-1431 in Adult Patients With Peripheral Neuropathic Pain

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

Summary

This study is designed to identify a titration regimen of ABX-1431 in adults with neuropathic pain with satisfactory tolerability to central nervous system (CNS) adverse events (AEs). During the course of this study, each participant will take a daily dose of ABX-1431 or a matching placebo for 28 days.

Detailed description

This is a double-blind, placebo-controlled, optimized titration study of ABX-1431 HCl. The study will explore whether patients experiencing ABX-1431-related CNS AE accommodate or become tolerant to them with continued dosing. The efficacy of ABX-1431 in treating neuropathic pain will be assessed by the change from baseline in pain intensity scores using numerical rating scale (NRS-11). All patients will undergo a screening visit for enrollment criteria. Eligible patients will be treated with daily medication for 28 days which will include some treatment with placebo and some treatment with ABX-1431 HCl. Patients will record their daily average pain using a paper numerical rating scale (NRS-11). This study will enroll up to 32 patients with peripheral neuropathic pain due to one of the four following diagnostic groups: post-herpetic neuralgia, diabetic peripheral neuropathy, small fiber neuropathy or post-traumatic neuropathic pain.

Conditions

Interventions

TypeNameDescription
DRUGABX-1431Capsules of either 2mg, 10mg, or 50mg
DRUGPlacebo oral capsuleplacebo to match

Timeline

Start date
2017-10-02
Primary completion
2019-05-07
Completion
2019-05-07
First posted
2018-02-27
Last updated
2019-07-12

Locations

1 site across 1 country: Moldova

Source: ClinicalTrials.gov record NCT03447756. Inclusion in this directory is not an endorsement.