Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
Condition: Painful Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Intervention: ricolinostat; Placebo
Intervention description: 120 mg per dose in 12 mL liquid formulation; 12 mL liquid formulation placebo
Intervention MeSH terms: Ricolinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double-blind
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetic Neuropathic Pain; Neuropathic Pain; HDAC6; ricolinostat; Painful Diabetic Peripheral Neuropathy; DPN

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.
    

Eligibility 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