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Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
Phase 2 trial testing ricolinostat in Painful Diabetic Peripheral Neuropathy in 282 participants. Completed in 28 April 2023.
| Lead sponsor | Regenacy Pharmaceuticals LLC |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 282 |
| Start date | 7 December 2020 |
| Primary completion | 31 October 2022 |
| Estimated completion | 28 April 2023 |
| Sites | 35 locations across United States |
Regenacy Pharmaceuticals LLC
Adults 18 to 80, any sex, with Painful Diabetic Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Difference between mean average pain intensity using the 11-point numerical pain rating scale (NRS) consisting of pain measurement from 0-10 with 10 being the worst pain and 0 being no pain at all.
| Group | Value | 95% CI |
|---|---|---|
| Ricolinostat | -1.21 | ± 1.4 |
| Placebo | -1.03 | ± 1.4 |
Change in non-pain neuropathic signs utilizing the Utah Early Neuropathy Score (UENS) which is a physical examination-based scale designed to assess early sensory predominant polyneuropathy. Compared with other scales, the UENS emphasizes severity and spatial distribution of pin (sharp) sensation loss in the foot and leg and focuses less on motor weakness. The UENS utilizes a numeric scale from 0-42, with higher scores indicating greater disease severity.
| Group | Value | 95% CI |
|---|---|---|
| Ricolinostat | -1.51 | ± 0.39 |
| Placebo | -1.84 | ± 0.40 |
Time frame: Baseline through 24 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ricolinostat | Placebo | Open Label Extension |
|---|---|---|---|---|
| Complex Migraine | Nervous system disorders | — | — | — |
| Worsening diarrhea | Gastrointestinal disorders | — | — | — |
| WORSENING CHRONIC DERMATITIS | Skin and subcutaneous tissue disorders | — | — | — |
| Diverticulitis | Infections and infestations | — | — | — |
| Proximal RCA Stenosis | Cardiac disorders | — | — | — |
| Skin Abrasion | Injury, poisoning and procedural complications | — | — | — |
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| NASAL BONE FRACTURE | Injury, poisoning and procedural complications | — | — | — |
| CHOLELITHIASIS | Hepatobiliary disorders | — | — | — |
| CHEST PAIN, NON-CARDIAC | General disorders | — | — | — |
| ATRIAL TACHYCARDIA | Cardiac disorders | — | — | — |
| CORONARY ARTERY DISEASE | Cardiac disorders | — | — | — |
| STROKE | Nervous system disorders | — | — | — |
| EPILEPTIC SEIZURES | Nervous system disorders | — | — | — |
| CARDIAC ARREST EPISODES | Cardiac disorders | — | — | — |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | — | — | — |
| SEVERE SYMPTOMATIC ORTHOSTATIC SEVERE HYPOTENSION | Vascular disorders | — | — | — |
| UNCONTROLED DIABETES | Metabolism and nutrition disorders | — | — | — |
| RIGHT FOOT CELLULITIS | Infections and infestations | — | — | — |
| PROXIMAL LAD STENOSIS | Cardiac disorders | — | — | — |
| LIVER LACERATION | Injury, poisoning and procedural complications | — | — | — |
| LEFT KNEE WOUND CONTAMINATION | Injury, poisoning and procedural complications | — | — | — |
| BILATERAL UPPER EXTREMITIES RECOVERED/RESOLVED ABRASIONS | Injury, poisoning and procedural complications | — | — | — |
| RIGHT FLANK ABRASIONS | Injury, poisoning and procedural complications | — | — | — |
| LEFT KNEE LACERATION | Injury, poisoning and procedural complications | — | — | — |
| Reaction | System | Ricolinostat | Placebo | Open Label Extension |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — |
| Vomitting | Gastrointestinal disorders | — | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Leukocytosis | Blood and lymphatic system disorders | — | — | — |
| Hemolysis | Blood and lymphatic system disorders | — | — | — |
| Vision Blurred | Eye disorders | — | — | — |
| Vertigo | Ear and labyrinth disorders | — | — | — |
| Difficulty Swallowing | Gastrointestinal disorders | — | — | — |
| Dry Mouth | Gastrointestinal disorders | — | — | — |
| Urinary Tract Infection | Infections and infestations | — | — | — |
| Common Cold | Infections and infestations | — | — | — |
| Neutrophil Count Decreased | Investigations | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — | — |
| Metabolic Acidosis | Metabolism and nutrition disorders | — | — | — |
| Spinal Stenosis | Musculoskeletal and connective tissue disorders | — | — | — |
| Drowsiness | Nervous system disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Facial Paralysis | Nervous system disorders | — | — | — |
| Dysuria | Renal and urinary disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Psoriasis | Skin and subcutaneous tissue disorders | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — |
| Urticaria | Skin and subcutaneous tissue disorders | — | — | — |
| Lymphocytic colitis | Gastrointestinal disorders | — | — | — |
| Thrombocytopenia | Investigations | — | — | — |
| Bloating | Gastrointestinal disorders | — | — | — |
Most-reported serious reactions: Complex Migraine, Worsening diarrhea, WORSENING CHRONIC DERMATITIS, Diverticulitis, Proximal RCA Stenosis, Skin Abrasion, Invasive Ductal Breast Carcinoma, NASAL BONE FRACTURE.
Data from ClinicalTrials.gov NCT03176472 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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