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Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy

NCT03176472 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2023-09-21

Study results available
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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

Interventions

DRUG

ricolinostat

120 mg per dose in 12 mL liquid formulation

DRUG

Placebo

12 mL liquid formulation placebo

Sponsors & Collaborators

  • Regenacy Pharmaceuticals LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2022-10-31
Completion
2023-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176472 on ClinicalTrials.gov