Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Painful Diabetic Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT03176472

Run by

Regenacy Pharmaceuticals LLC

People needed

282

Starts

2020-12-07

Expected to finish

2023-04-28

Last updated by the study team

2023-09-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pinnacle Research Group LLC — Anniston, Alabama, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Diabetes/Lipid Management & Research Center — Huntington Beach, California, United States
• National Research Institute — Huntington Park, California, United States
• Altman Clinical and Translational Research Institute — La Jolla, California, United States
• Torrance Clinical Research Institute Inc — Lomita, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Center for Clinical Research Inc — San Francisco, California, United States
• Diablo Clinical Research Inc — Walnut Creek, California, United States
• Innovative Research of West Florida Inc — Clearwater, Florida, United States
• DeLand Clinical Research Unit — Lake Mary, Florida, United States
• ClinCloud LLC — Maitland, Florida, United States
• APF Research LLC — Miami, Florida, United States
• International Research Associates LLC — Miami, Florida, United States
• Sensible Healthcare LLC — Ocoee, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Metabolic Research Institute Inc — West Palm Beach, Florida, United States
• Physicians Research Associates, LLC — Lawrenceville, Georgia, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• MediSphere Medical Research Center, LLC — Evansville, Indiana, United States
• Tandem Clinical Research — Marrero, Louisiana, United States
• Olive Branch Family Medical Center — Olive Branch, Mississippi, United States
• Advanced Biomedical Research of America — Las Vegas, Nevada, United States
• Hassman Research Institute — Berlin, New Jersey, United States

Full record on ClinicalTrials.gov

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