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History of Changes for Study: NCT03176472
Ricolinostat in Patients With Diabetic Neuropathic Pain
Latest version (submitted July 18, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 1, 2017 None (earliest Version on record)
2 June 5, 2017 Eligibility, Outcome Measures, Arms and Interventions, Study Description and Study Status
3 April 12, 2018 Study Status
4 April 4, 2019 Study Status
5 April 6, 2020 Study Status
6 December 3, 2020 Outcome Measures, Study Status, Eligibility, Conditions, Study Description, Study Identification, Arms and Interventions and Study Design
7 December 29, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
8 January 14, 2021 Study Status and Contacts/Locations
9 February 5, 2021 Study Status and Contacts/Locations
10 February 24, 2021 Contacts/Locations and Study Status
11 March 29, 2021 Contacts/Locations and Study Status
12 April 22, 2021 Study Status and Contacts/Locations
13 July 6, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
14 July 18, 2022 Study Design and Study Status
Comparison Format:

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Study NCT03176472
Submitted Date:  June 1, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: REGY-DN-201
Brief Title: Ricolinostat in Patients With Diabetic Neuropathic Pain
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Ricolinostat in Patients With Diabetic Neuropathic Pain
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2017
Overall Status: Not yet recruiting
Study Start: October 2017
Primary Completion: October 2019 [Anticipated]
Study Completion: January 2020 [Anticipated]
First Submitted: May 18, 2017
First Submitted that
Met QC Criteria:
June 1, 2017
First Posted: June 5, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
June 1, 2017
Last Update Posted: June 5, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Regenacy Pharmaceuticals LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is a randomized, double-blind, parallel group clinical study of up to 450 patients designed to evaluate the safety and efficacy of ricolinostat for DNP.
Detailed Description:
Open or close this module Conditions
Conditions: Diabetic Neuropathic Pain
Keywords: Diabetic Neuropathic Pain
Neuropathic Pain
HDAC6
ricolinostat
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 450 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ricolinostat
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
Drug: ricolinostat
120 mg per dose in 12 mL liquid formulation
Placebo Comparator: placebo
Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken QD by mouth
Drug: Placebo
12 mL liquid formulation placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Average Pain Intensity (NRS)
[ Time Frame: Baseline week [Day-7 to Day 1] compared to Final week [Day 22 to Day 28] ]

Difference between mean average pain intensity
Secondary Outcome Measures:
1. BPI-SF pain score
[ Time Frame: Day 1 to Day 28 ]

Change in mean BPI-SF pain intensity and interference score
2. NTSS-6
[ Time Frame: Day 1 to Day 28 ]

Change in neuropathy symptoms
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Type 1 or Type 2 diabetes with optimized and stable glycemic control during the 3 months prior to Screening
  • Painful distal symmetric sensorimotor polyneuropathy ≥6 months
  • Douleur Neuropathique 4 (DN4) score of ≥4
  • Use and failure of at least 2 other treatments for neuropathic pain
  • Satisfactory diary data during the 7-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
  • BMI >40 kg/m2
  • Suicidal ideation/behavior as measured by the C-SSRS
  • Radiculopathy or other neuropathic conditions, including chemotherapy-induced neuropathy
  • Other chronic pain condition(s) that could affect compliance with pain medication restrictions or confound pain assessments
  • Known history of opioid abuse or opioid dependence in the past 5 years, or opioid use at a dose of ≥30 MME on 3 or more days a week during the month prior to Screening
  • 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 ≥480 msec in the presence of a QRS >120 msec
  • Any of the following hematology abnormalities at Screening;
  • Hemoglobin <11.5 g/dL (female) or <13 g/dL (male)
  • Complete blood count outside the normal reference range
  • Creatinine >1.5 mg/dL or a calculated creatinine clearance of <60 mL/min
  • Serum bilirubin values >2.0 mg/dL (>3.0 mg/dL for hereditary benign hyperbilirubinemia) and serum ALT and/or AST values >1.5 x the upper limit of normal
  • 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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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