Overview

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