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Ricolinostat in Patients With Diabetic Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03176472
Recruitment Status : Not yet recruiting
First Posted : June 5, 2017
Last Update Posted : April 7, 2020
Information provided by (Responsible Party):
Regenacy Pharmaceuticals LLC

Brief Summary:
This is a randomized, double-blind, parallel group clinical study of up to 450 patients designed to evaluate the safety and efficacy of ricolinostat for Diabetic Neuropathic Pain (DNP).

Condition or disease Intervention/treatment Phase
Diabetic Neuropathic Pain Drug: ricolinostat Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
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
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Ricolinostat in Patients With Diabetic Neuropathic Pain
Estimated Study Start Date : January 15, 2021
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : January 15, 2023

Arm Intervention/treatment
Experimental: ricolinostat
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
Drug: ricolinostat
120 mg per dose in 12 mL liquid formulation

Placebo Comparator: placebo
Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth
Drug: Placebo
12 mL liquid formulation placebo

Primary Outcome Measures :
  1. Average Pain Intensity (NRS) [ Time Frame: Baseline week [Day-7 to Day 1] compared to Final week [Day 22 to Day 28] ]
    Difference between mean average pain intensity

Secondary Outcome Measures :
  1. Brief Pain Inventory Questionnaire - Short Form (BPI-SF) pain score [ Time Frame: Day 1 to Day 28 ]
    Change in mean BPI-SF pain intensity and interference score

  2. Neuropathy Total Symptom Score - 6 (NTSS-6) [ Time Frame: Day 1 to Day 28 ]
    Change in neuropathy symptoms

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 1 or Type 2 diabetes with optimized and stable glycemic control during the 3 months prior to Screening
  • Painful distal symmetric sensorimotor polyneuropathy ≥6 months
  • Douleur Neuropathique 4 (DN4) score of ≥4
  • Use and failure of at least 2 other treatments for neuropathic pain
  • Satisfactory diary data during the 7-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
  • Suicidal ideation/behavior as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Radiculopathy or other neuropathic conditions, including chemotherapy-induced neuropathy
  • Other chronic pain condition(s) that could affect compliance with pain medication restrictions or confound pain assessments
  • Known history of opioid abuse or opioid dependence in the past 5 years, or opioid use at a dose of ≥30 morphine milligram equivalents (MME) on 3 or more days a week during the month prior to Screening
  • 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 ≥480 msec in the presence of a QRS >120 msec
  • Any of the following hematology abnormalities at Screening;
  • Hemoglobin <11.5 g/dL (female) or <13 g/dL (male)
  • Complete blood count outside the normal reference range
  • Creatinine >1.5 mg/dL or a calculated creatinine clearance of <60 mL/min
  • Serum bilirubin values >2.0 mg/dL (>3.0 mg/dL for hereditary benign hyperbilirubinemia) and serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values >1.5 x the upper limit of normal
  • 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
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Responsible Party: Regenacy Pharmaceuticals LLC Identifier: NCT03176472    
Other Study ID Numbers: REGY-DN-201
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regenacy Pharmaceuticals LLC:
Diabetic Neuropathic Pain
Neuropathic Pain
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action