Titration Study of ABX-1431

NCT ID: NCT03447756

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2019-05-07

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.

Conditions

Post Herpetic Neuralgia; Diabetic Peripheral Neuropathy; Small Fiber Neuropathy; Post-Traumatic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ABX-1431

One or more oral capsules containing 2 mg or 10 mg or 50 mg of ABX-1431 HCl or matching placebo are administered daily to enrolled patients. Patients will undergo a blinded dose escalation. All patients will receive placebo on some days to assess safety and neuropathic pain. Patients will undergo an optimized titration of ABX-1431 HCl with the daily dose between 8 mg and 24 mg of ABX-1431. Each patients dose will be determined by the Investigator based on assessment of adverse events.

Group Type: EXPERIMENTAL

ABX-1431

Intervention Type: DRUG

Capsules of either 2mg, 10mg, or 50mg

Placebo oral capsule

One or more oral capsules containing placebo are administered daily to enrolled patients. Patients will undergo a blinded dose escalation. All patients will receive placebo on some days to assess safety and neuropathic pain. Patients will undergo an optimized titration of placebo. Each patients dose will be determined by the Investigator based on assessment of adverse events.

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

placebo to match

Interventions

ABX-1431

Capsules of either 2mg, 10mg, or 50mg

Intervention Type: DRUG

Placebo oral capsule

placebo to match

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient is a male or female over the age of 18 years of age at the Screening Visit.
• Patient has a peripheral neuropathic pain in one of the following diagnostic groups that is persistent for > 3 months

• Post-herpetic neuralgia
• Diabetic peripheral neuropathy
• Small fiber neuropathy
• Post-traumatic neuropathic pain
• Patient's median NRS-11 pain intensity score must be ≥ 4 during the baseline period
• If a patient enters the trial on daily background neuropathic pain medications, then the patient must be on stable dose of medications for at least 30 days before enrollment and throughout the study.
• Patient is able to understand and comply with the protocol procedures for the entire trial and must give written informed consent.
• Men and Women must agree to a medically approved contraceptive regimen.

Exclusion Criteria

• Patient is taking potent cytochrome P450 3A4/5 inducers or inhibitors
• Patient has received injection therapies (e.g., botulinum toxin, anesthetic or nerve block) or transcutaneous electrical stimulation to control pain in the past 60 days
• Patient has evidence of alcohol, drug or chemical abuse in the year before the Screening Visit.
• Patient is a lactating or pregnant female or a female who intends to become pregnant within 90 days following the last dose of investigational product.
• Patient has specific laboratory abnormalities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abide Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vitale Lisnic, PhD

Role: PRINCIPAL_INVESTIGATOR

ARENSIA EXPLORATORY MEDICINE

Locations

Republican Clinical Hospital

Chisinau, , Moldova

Countries

Moldova

Other Identifiers

ABX-1431_PN014

Identifier Type: -

Identifier Source: org_study_id