Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy

NCT03176472 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: REGY-DN-201
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 35

Brief 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.

Conditions

Painful Diabetic Peripheral Neuropathy

Keywords

Diabetic Neuropathic Pain; Neuropathic Pain; HDAC6; ricolinostat; Painful Diabetic Peripheral Neuropathy; DPN

Outcome Measures

Primary Outcomes (1)

• Change in Mean Average Pain Intensity (NRS)

  Difference between mean average pain intensity using the 11-point numerical pain rating scale (NRS) consisting of pain measurement from 0-10 with 10 being the worst pain and 0 being no pain at all.

  Baseline week [Day-7 to Day 1] compared to Final week [12 Weeks]

Secondary Outcomes (1)

• Change in Non-pain Neuropathic Signs (UENS)

  Baseline week [Day-7 to Day 1] compared to Week 12

Study Arms (2)

ricolinostat

EXPERIMENTAL

Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)

Drug: ricolinostat

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ricolinostat DRUG

120 mg per dose in 12 mL liquid formulation

Also known as: ACY-1215

ricolinostat

Placebo DRUG

12 mL liquid formulation placebo

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Regenacy Pharmaceuticals LLC: lead

Study Sites (35)

Pinnacle Research Group LLC

Anniston, Alabama, 36207, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Diabetes/Lipid Management & Research Center

Huntington Beach, California, 92648, United States

Location

National Research Institute

Huntington Park, California, 90255, United States

Location

Altman Clinical and Translational Research Institute

La Jolla, California, 92037, United States

Location

Torrance Clinical Research Institute Inc

Lomita, California, 90717, United States

Location

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Center for Clinical Research Inc

San Francisco, California, 94115, United States

Location

Diablo Clinical Research Inc

Walnut Creek, California, 94598, United States

Location

Innovative Research of West Florida Inc

Clearwater, Florida, 33756, United States

Location

DeLand Clinical Research Unit

Lake Mary, Florida, 32746, United States

Location

ClinCloud LLC

Maitland, Florida, 32751, United States

Location

APF Research LLC

Miami, Florida, 33134, United States

Location

International Research Associates LLC

Miami, Florida, 33183, United States

Location

Sensible Healthcare LLC

Ocoee, Florida, 34761, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Meridien Research

Tampa, Florida, 33634, United States

Location

Metabolic Research Institute Inc

West Palm Beach, Florida, 33401, United States

Location

Physicians Research Associates, LLC

Lawrenceville, Georgia, 30046, United States

Location

Rocky Mountain Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Olive Branch Family Medical Center

Olive Branch, Mississippi, 38654, United States

Location

Advanced Biomedical Research of America

Las Vegas, Nevada, 89123, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Triad Clinical Trials

Greensboro, North Carolina, 27410, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Nerve and Muscle Center of Texas

Houston, Texas, 77030, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

Location

Wasatch Clinical Research LLC

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Neuralgia

Interventions

ricolinostat

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. David Michelson, CMO
• Organization: Regenacy Pharmaceuticals Inc.

dmichelson@regenacy.com

2676639826

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: June 5, 2017
• Study Start: December 7, 2020
• Primary Completion: October 31, 2022
• Study Completion: April 28, 2023
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (35)