Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
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| ClinicalTrials.gov Identifier: NCT03176472 |
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Recruitment Status :
Completed
First Posted : June 5, 2017
Results First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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Sponsor:
Regenacy Pharmaceuticals LLC
Information provided by (Responsible Party):
Regenacy Pharmaceuticals LLC
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Painful Diabetic Peripheral Neuropathy |
| Interventions |
Drug: ricolinostat Drug: Placebo |
| Enrollment | 282 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Ricolinostat | Placebo |
|---|---|---|
 Arm/Group Description |
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, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth Placebo: 12 mL liquid formulation placebo |
| Period Title: Double Blind Treatment Period | ||
| Started | 142 | 140 |
| Completed | 132 | 124 |
| Not Completed | 10 | 16 |
| Reason Not Completed | ||
| Withdrawal by Subject | 5 | 10 |
| Adverse Event | 0 | 5 |
| Lost to Follow-up | 3 | 0 |
| Physician Decision | 0 | 1 |
| Protocol Violation | 1 | 0 |
| Not Provided | 1 | 0 |
| Period Title: Open Label Extension | ||
| Started | 131 | 121 |
| Completed | 123 | 109 |
| Not Completed | 8 | 12 |
| Reason Not Completed | ||
| Withdrawal by Subject | 3 | 4 |
| Adverse Event | 2 | 4 |
| Lost to Follow-up | 1 | 2 |
| Protocol Violation | 0 | 1 |
| Not Provided | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | Ricolinostat | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
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, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth Placebo: 12 mL liquid formulation placebo |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 142 | 140 | 282 | |
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Baseline Analysis Population Description |
The Intent To Treat (ITT) Population is defined as all randomized subjects regardless of study drug administration
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 142 participants | 140 participants | 282 participants | |
| 59.5 (9.64) | 60.9 (7.81) | 60.2 (8.79) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 142 participants | 140 participants | 282 participants | |
| Female |
86 60.6%
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83 59.3%
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169 59.9%
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| Male |
56 39.4%
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57 40.7%
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113 40.1%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 142 participants | 140 participants | 282 participants | |
| American Indian or Alaska Native |
2 1.4%
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0 0.0%
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2 0.7%
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| Asian |
6 4.2%
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3 2.1%
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9 3.2%
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| Native Hawaiian or Other Pacific Islander |
1 0.7%
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1 0.7%
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2 0.7%
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| Black or African American |
37 26.1%
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39 27.9%
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76 27.0%
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| White |
93 65.5%
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95 67.9%
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188 66.7%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
3 2.1%
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2 1.4%
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5 1.8%
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Height
Mean (Standard Deviation) Unit of measure: Centimeters |
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| Number Analyzed | 142 participants | 140 participants | 282 participants | |
| 172.7 (9.82) | 173.1 (9.91) | 172.9 (9.85) | ||
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Weight
Mean (Standard Deviation) Unit of measure: Kg |
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| Number Analyzed | 142 participants | 140 participants | 282 participants | |
| 93.7 (18.29) | 96.76 (16.50) | 95.22 (17.46) | ||
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Body Mass Index (BMI)
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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| Number Analyzed | 142 participants | 140 participants | 282 participants | |
| 31.31 (4.91) | 32.21 (4.17) | 31.75 (4.57) | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Dr. David Michelson, CMO |
| Organization: | Regenacy Pharmaceuticals Inc. |
| Phone: | 2676639826 |
| EMail: | dmichelson@regenacy.com |
| Responsible Party: | Regenacy Pharmaceuticals LLC |
| ClinicalTrials.gov Identifier: | NCT03176472 |
| Other Study ID Numbers: |
REGY-DN-201 |
| First Submitted: | May 18, 2017 |
| First Posted: | June 5, 2017 |
| Results First Submitted: | May 30, 2023 |
| Results First Posted: | September 21, 2023 |
| Last Update Posted: | September 21, 2023 |