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Titration Study of ABX-1431

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ClinicalTrials.gov Identifier: NCT03447756
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Abide Therapeutics

Tracking Information
First Submitted Date  ICMJE February 9, 2018
First Posted Date  ICMJE February 27, 2018
Last Update Posted Date July 12, 2019
Actual Study Start Date  ICMJE October 2, 2017
Actual Primary Completion Date May 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
Identify a titration regimen of ABX-1431 [ Time Frame: 28 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03447756 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
  • Tolerance to ABX-1431 related CNS AEs determined by whether or not AEs resolve with continued dosing [ Time Frame: 28 days ]
  • Numerical Rating Scale (NRS-11) [ Time Frame: 20 days ]
    Change from Baseline in Pain Scores on the Numerical Rating Scale-11 (NRS-11) at 20 days.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Titration Study of ABX-1431
Official Title  ICMJE A Randomized, Placebo-Controlled, Optimized Titration Study of ABX-1431 in Adult Patients With Peripheral Neuropathic Pain
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Post Herpetic Neuralgia
  • Diabetic Peripheral Neuropathy
  • Small Fiber Neuropathy
  • Post-Traumatic Neuralgia
Intervention  ICMJE
  • Drug: ABX-1431
    Capsules of either 2mg, 10mg, or 50mg
  • Drug: Placebo oral capsule
    placebo to match
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: ABX-1431
  • Placebo Comparator: 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.
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2019)
39
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2018)
32
Actual Study Completion Date  ICMJE May 7, 2019
Actual Primary Completion Date May 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Moldova, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03447756
Other Study ID Numbers  ICMJE ABX-1431_PN014
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abide Therapeutics
Study Sponsor  ICMJE Abide Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vitale Lisnic, PhD ARENSIA EXPLORATORY MEDICINE
PRS Account Abide Therapeutics
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP