Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT03447756
Brief 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.
Study:
NCT03447756
Study Brief:
Protocol Section:
NCT03447756