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ricolinostat for Diabetic Neuropathy

Phase 2
Waitlist Available
Research Sponsored by Regenacy Pharmaceuticals LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline week [day-7 to day 1] compared to week 12
Awards & highlights

Study Summary

This trial will study whether the HDAC6 inhibitor ricolinostat is safe and effective for treating painful diabetic neuropathy.

Eligible Conditions
  • Painful Diabetic Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline week [day-7 to day 1] compared to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline week [day-7 to day 1] compared to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Mean Average Pain Intensity (NRS)
Secondary outcome measures
Change in Non-pain Neuropathic Signs (UENS)

Side effects data

From 2023 Phase 2 trial • 282 Patients • NCT03176472
2%
Diarrhea
2%
Nausea
1%
Invasive Ductal Breast Carcinoma
1%
CHOLELITHIASIS
1%
Anorexia
1%
Cough
1%
LEFT KNEE LACERATION
1%
BILATERAL LUNG CONSOLIDATION
1%
Urinary Tract Infection
1%
Skin Abrasion
1%
TONGUE LACERATION
1%
Diverticulitis
1%
Psoriasis
1%
UNCONTROLED DIABETES
1%
HYPERKALEMIA
1%
Thrombocytopenia
1%
Dysuria
1%
Drowsiness
1%
NASAL BONE FRACTURE
1%
SEVERE SYMPTOMATIC ORTHOSTATIC SEVERE HYPOTENSION
1%
Neutrophil Count Decreased
1%
LIVER LACERATION
1%
BILATERAL UPPER EXTREMITIES RECOVERED/RESOLVED ABRASIONS
1%
RIGHT FLANK ABRASIONS
1%
RIGHT FOOT CELLULITIS
1%
Dizziness
1%
LEFT KNEE WOUND CONTAMINATION
1%
Vomitting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ricolinostat
Placebo
Open Label Extension

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ricolinostatExperimental Treatment1 Intervention
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
Group II: placeboPlacebo Group1 Intervention
Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ricolinostat
2020
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

Regenacy Pharmaceuticals LLCLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the enrolment criteria for this trial?

"This trial is seeking 282 patients aged 18-80 who have an affliction of the peripheral nervous system and a DN4 score of 4 or higher."

Answered by AI

Does the trial accept participants who are of legal age?

"This trial is open to participants aged between 18 and 80. Those younger than 18 are eligible for 76 different trials, and those over 65 can apply for 406 other studies."

Answered by AI

Does this experiment currently have openings for participants?

"At the time of writing, this trial is not actively enrolling participants. The study was initially posted on December 7th 2020 and last amended on July 18th 2022. For those searching for other trials, 504 clinical studies are currently recruiting patients with peripheral nervous system diseases and 3 trials require ricolinostat subjects."

Answered by AI

What is the geographic range of this research investigation?

"Patients can access the trial at National Research Institute in Huntington Park, Providence Clinical Research in North Hollywood, Tandem Clinical Research in Marrero and other 35 sites."

Answered by AI

What is the scope of participation for this medical trial?

"At present, the recruitment for this trial has been concluded. It was originally posted on December 7th 2020 and last updated on July 18th 2022. If you are seeking other studies, there is an abundance of options; 504 trials for peripheral nervous system diseases and 3 clinical trials that involve ricolinostat currently welcome participants."

Answered by AI

Are there any precedents for the use of ricolinostat in research?

"Presently, 3 clinical trials are in progress analyzing ricolinostat. None of these active studies have advanced to Phase 3 yet. Though most research for this medication is based out of Las Vegas, Nevada, 62 different sites across the US are participating in related trials."

Answered by AI

Does this experiment represent a pioneering venture in the medical field?

"Currently, there are 3 ongoing clinical trials for ricolinostat in 4 countries across 48 cities. This medication's first trial was funded by Celgene and concluded its Phase 1 & 2 approval stages with 103 participants back in 2014. Since then, 18,327 scientific studies have been conducted on this drug."

Answered by AI

What potential hazards may be associated with ricolinostat use?

"As the trial is currently in Phase 2, which only provides some safety data but none regarding efficacy, ricolinostat was assigned a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Florida
California
How old are they?
65+
18 - 65
What site did they apply to?
Diabetes/Lipid Management & Research Center
National Research Institute
Diablo Clinical Research Inc
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

painful neuropathy and CRPS not diabetic related.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

is this for diabetics only?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
2020. "Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03176472.
~65 spots leftby Apr 2025
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