Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy

• Status: Recruiting
• Trial end date: 2022-06-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, 2-arm, parallel group study of up to 274 evaluable patients designed to evaluate the safety and efficacy of the histone deacetylase 6 (HDAC6) inhibitor ricolinostat for painful DPN.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regenacy Pharmaceuticals LLC
• Treatments: Ricolinostat

Criteria

Inclusion Criteria:

• Type 1 or Type 2 diabetes of at least 6 months with optimized and stable glycemic control during the 3 months prior to Screening

• Painful distal symmetric sensorimotor polyneuropathy due to diabetes

• Douleur Neuropathique 4 (DN4) score of ≥4

• Satisfactory diary data during the 14-day Pain Observation period determined by an algorithm that includes diary compliance, overall level of pain and day-to-day variability in pain

Exclusion Criteria:

• Pregnant or lactating

• Body Mass Index (BMI) >40 kg/m2

• Presence of any neuropathy other than DPN and/or significant risk factors for neuropathy other than diabetes

• Other pain conditions that could confound the results of this study, or other chronic pain condition(s) that could affect compliance with pain medication restrictions or confound pain assessments

• Painful DPN patients who have undergone lower limb amputations, are non-ambulatory, or whose walking is so impaired as to require a walker or other assistance for ambulation

• Have met Diagnostic and Statistical Manual of Mental Disorders V (DSM V) criteria for opioid use disorder or alcohol use disorder

• Opioid use at a dose of ≥ 30 morphine milligram equivalents on 3 or more days a week during the month prior to Screening

• Suicidal ideation/behavior as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

• The use of marijuana or cannabidiol (CBD) during the 30 days prior to starting study drug

• Chronic use of over-the-counter capsaicin on extremities within 3 months of Screening and/or prescription Qutenza use within 6 months of Screening

• Corrected QT interval at Screening using QTcF of ≥450 msec (male) or ≥460 msec (female)

• Hemoglobin < 11.5 g/dL (female) or < 13 g/dL (male), total white blood cell count < 2500/mm3, neutrophil count < 1250/mm3, lymphocyte count < 1000/mm3, or platelet count < 100,000/mm3

• HIV positive and/or active hepatitis virus (A, B, or C) infection

• Current or previous (≤1 month of Screening) enrollment in a clinical trial involving treatment with an investigational product

• Any known recent exposure within the 14 days prior to initial Screening to coronavirus disease 2019 (COVID-19) or symptoms of COVID-19 infection or other reason to suspect COVID-19 infection as assessed by the Investigator at the time of initial Screening