Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy (NCT03176472) | Clinical Trial Compass
CompletedPhase 2
Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
United States282 participantsStarted 2020-12-07
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 capsai…
What they're measuring
1
Change in Mean Average Pain Intensity (NRS)
Timeframe: Baseline week [Day-7 to Day 1] compared to Final week [12 Weeks]