Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy

  • STATUS
    Recruiting
  • End date
    Jun 15, 2022
  • participants needed
    274
  • sponsor
    Regenacy Pharmaceuticals LLC
Updated on 2 May 2021

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.

Description

The study includes an approximately 12 week randomized, double-blind, placebo controlled Treatment period in which patients will receive either ricolinostat or placebo, followed by an approximately 12 week open label Safety Extension period during which all patients will receive ricolinostat 120 mg daily.

Prior to randomization, patients will be enrolled in a baseline Pain Observation period from Day -14 to Day -1, during which the NRS (average and worst pain) will be recorded daily using an electronic daily diary that will be completed by patients to allow patients to familiarize themselves with the pain rating procedures, and to establish a baseline and confirm eligibility to participate. Patients will also initiate daily dosing during this time to evaluate compliance eligibility for participation. A daily diary will be used by the patient to record the pain assessments and rescue medication use. A follow-up phone contact will be conducted at Day -7 to Day -5 to review diary and dosing compliance.

Following the baseline Pain Observation period, patients who meet entry criteria will be randomized in a 1:1 ratio to receive either ricolinostat or placebo. During the 12-week double-blind, placebo-controlled Treatment period, patients will return for assessments in accordance with the schedule of assessments. At the conclusion of the approximately 12 week open label Safety Extension period, patients will enter a Follow-up safety washout and assessment period, which will incorporate 2 visits at approximately 2 and 4 weeks following the final Safety Extension visit, with assessments performed as outlined in the schedule of assessments.

Details
Condition Painful Diabetic Peripheral Neuropathy
Treatment Placebo, ricolinostat
Clinical Study IdentifierNCT03176472
SponsorRegenacy Pharmaceuticals LLC
Last Modified on2 May 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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