Evidence map›Paper›PMID 37899940›Full record

ArticlePain reports2023

A randomized, double-blind, placebo-controlled study of histone deacetylase type 6 inhibition for the treatment of painful diabetic peripheral neuropathy.

David Michelson, William W Chin, Robert H Dworkin, Roy Freeman, David N Herrmann, Ralph Mazitschek, Rodica Pop-Busui, Aziz Shaibani, James Vornov, Melissa Jones and 6 more

Open access · goldAbstract read
In one paragraph

Article in Pain reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.9field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
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  5. Review
  6. Mechanism-based nonopioid analgesic targets.The Journal of clinical investigation · 2025
    Review
  7. Diabetic neuropathy: cutting-edge research and future directions.Signal transduction and targeted therapy · 2025
    Review
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 1 country.

David MichelsonRegenacy Pharmaceuticals, Inc, Waltham, MA, USA.ORCID https://orcid.org/0009-0005-5804-1424
William W ChinRegenacy Pharmaceuticals, Inc, Waltham, MA, USA.
Robert H DworkinUniversity of Rochester, Rochester, NY, USA.
Roy FreemanBeth Israel Deaconess Medical Center, Harvard University, Boston, MA, USA.
David N HerrmannUniversity of Rochester, Rochester, NY, USA.
Ralph MazitschekMassachusetts General Hospital, Harvard University, Boston, MA, USA.
Rodica Pop-BusuiDepartment of Internal Medicine, Metabolism, Endocrinology and Diabetes, University of Michigan, Ann Arbor, MI, USA.
Aziz ShaibaniBaylor College of Medicine, Houston, TX, USA.
James VornovMedpace, Inc. and Johns Hopkins School of Medicine, Baltimore, MD, USA.
Melissa JonesMedpace, Inc, Cincinnati, OH, USA.
Matthew JarpeRegenacy Pharmaceuticals, Inc, Waltham, MA, USA.
Brittany HaderMedpace, Inc, Cincinnati, OH, USA.
Theresa VieraMedpace, Inc, Cincinnati, OH, USA.
Michelle HylanRegenacy Pharmaceuticals, Inc, Waltham, MA, USA.
Tim KachmarRegenacy Pharmaceuticals, Inc, Waltham, MA, USA.
Simon JonesRegenacy Pharmaceuticals, Inc, Waltham, MA, USA.
Medpace (United States) · USUniversity of Rochester · USBaylor College of Medicine · USBeth Israel Deaconess Medical Center · USHarvard University · USUniversity of Michigan · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Current treatments for painful diabetic peripheral neuropathy (DPN) are insufficiently effective for many individuals and do not treat nonpain signs and symptoms. The enzyme histone deacetylase type 6 (HDAC6) may play a role in the pathophysiology of painful DPN, and inhibition of HDAC6 has been proposed as a potential treatment. Objectives: To assess the efficacy and safety of the novel HDAC6 inhibitor ricolinostat for the treatment of painful diabetic peripheral neuropathy. Methods: We conducted a 12-week randomized, double-blind, placebo-controlled phase 2 study of the efficacy of ricolinostat, a novel selective HDAC6 inhibitor, in 282 individuals with painful DPN. The primary outcome was the change in the patient-reported pain using a daily diary, and a key secondary outcome was severity of nonpain neuropathic signs using the Utah Early Neuropathy Scale (UENS) score. Results: At the 12-week assessment, changes in average daily pain and UENS scores were not different between the ricolinostat and placebo groups. Conclusion: These results do not support the use of the HDAC6 inhibitor ricolinostat as a treatment for neuropathic pain in DPN for periods up to 12 weeks.

Indexed as

Histone deacetylase 6 inhibitionPainful diabetic peripheral neuropathy

Identifiers

PMID37899940
PMCPMC10611336
OpenAlexW4388035397

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.