CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 282 enrolled
Drug / intervention
ricolinostat +1 moredrug
Likely dose
ricolinostat 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03176472
NCT03176472Phase 2Completed

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy

Regenacy Pharmaceuticals LLC·interventional·Posted Jun 5, 2017·Updated Sep 21, 2023

In Brief

A Phase 2 clinical trial evaluating ricolinostat and Placebo for Painful Diabetic Peripheral Neuropathy. Completed, enrolled 282 participants across 35 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 5, 2017
Enrollment StartDec 7, 2020
Primary CompletionOct 31, 2022
Study CompletionApr 28, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.1 years ago

Interventions

ricolinostatdrug

120 mg per dose in 12 mL liquid formulation

Placebodrug

12 mL liquid formulation placebo