Back to resultsTitration Study of ABX-1431
Primary Purpose
Post Herpetic Neuralgia, Diabetic Peripheral Neuropathy, Small Fiber Neuropathy
Status
Completed
Phase
Phase 1
Locations
Moldova, Republic of
Study Type
Interventional
Intervention
ABX-1431
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Post Herpetic Neuralgia
Eligibility Criteria
Key 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.
Key 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
Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Republican Clinical Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ABX-1431
Placebo oral capsule
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Identify a titration regimen of ABX-1431
The number of patients unable to continue due to central nervous system (CNS) adverse events (AEs) while exceeding mean plasma ABX-1431 AUC_0-24 of 190 ng*hr/ml or inhibiting 2-arachidonoylglycerol (2-AG) hydrolysis in peripheral blood mononuclear cells (PBMC) by more than 62% time-weighted inhibition over 24-hours.
Secondary Outcome Measures
Tolerance to ABX-1431 related CNS AEs determined by whether or not AEs resolve with continued dosing
Numerical Rating Scale (NRS-11)
Change from Baseline in Pain Scores on the Numerical Rating Scale-11 (NRS-11) at 20 days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03447756
Brief Title
Titration Study of ABX-1431
Official Title
A Randomized, Placebo-Controlled, Optimized Titration Study of ABX-1431 in Adult Patients With Peripheral Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
May 7, 2019 (Actual)
Study Completion Date
May 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abide Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Herpetic Neuralgia, Diabetic Peripheral Neuropathy, Small Fiber Neuropathy, Post-Traumatic Neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABX-1431
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo oral capsule
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ABX-1431
Intervention Description
Capsules of either 2mg, 10mg, or 50mg
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
placebo to match
Primary Outcome Measure Information:
Title
Identify a titration regimen of ABX-1431
Description
The number of patients unable to continue due to central nervous system (CNS) adverse events (AEs) while exceeding mean plasma ABX-1431 AUC_0-24 of 190 ng*hr/ml or inhibiting 2-arachidonoylglycerol (2-AG) hydrolysis in peripheral blood mononuclear cells (PBMC) by more than 62% time-weighted inhibition over 24-hours.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Tolerance to ABX-1431 related CNS AEs determined by whether or not AEs resolve with continued dosing
Time Frame
28 days
Title
Numerical Rating Scale (NRS-11)
Description
Change from Baseline in Pain Scores on the Numerical Rating Scale-11 (NRS-11) at 20 days.
Time Frame
20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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.
Key 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
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vitale Lisnic, PhD
Organizational Affiliation
ARENSIA EXPLORATORY MEDICINE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Republican Clinical Hospital
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Titration Study of ABX-1431
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