Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
NCT ID: NCT03176472
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
282 participants
INTERVENTIONAL
2020-12-07
2023-04-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ricolinostat
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
ricolinostat
120 mg per dose in 12 mL liquid formulation
placebo
Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth
Placebo
12 mL liquid formulation placebo
Interventions
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ricolinostat
120 mg per dose in 12 mL liquid formulation
Placebo
12 mL liquid formulation placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Regenacy Pharmaceuticals LLC
INDUSTRY
Responsible Party
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Locations
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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
NY Scientific
Brooklyn, New York, United States
Triad Clinical Trials
Greensboro, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Nerve and Muscle Center of Texas
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, United States
Wasatch Clinical Research LLC
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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REGY-DN-201
Identifier Type: -
Identifier Source: org_study_id
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