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Ricolinostat in Patients With Diabetic Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT03176472
Recruitment Status : Not yet recruiting
First Posted : June 5, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Anticipated Study Start Date : October 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020
Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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

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
More Information

Responsible Party: Regenacy Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT03176472     History of Changes
Other Study ID Numbers: REGY-DN-201
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
HDAC6
ricolinostat

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms