Efficacy and Safety of VM202 in Painful Diabetic Peripheral Neuropathy -The HOPES Trial

NCT04087941 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: HOPES
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, randomized, placebo-controlled, single-center, 12-month phase 2 study designed to assess the safety and efficacy of VM202 as a replacement for opioid analgesics in opioid-tolerant subjects with painful diabetic peripheral neuropathy (DPN).

Conditions

Painful Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change in 24-hour Morphine Milligram Equivalents (MME)

  The percent change in 24-hour MME use from baseline week to the week prior to Day 180 obtained from the Daily Pain and Sleep Interference Diary

  baseline week to week prior to Day 180

Secondary Outcomes (7)

• Opioid use - mean dose

  Day 90, Day 180, Day 270, Day 365

• Opioid use - percent change from baseline

  Day 90, Day 180, Day 270, Day 365

• Opioid use - percent of subjects who are dose-reduced/opioid free

  Day 90, Day 180, Day 270, Day 365

• Opioid-Related AE - Cognition

  Day 90, Day 180, Day 270, Day 365

• Opioid-Related AE - Bowel Function

  Day 90, Day 180, Day 270, Day 365

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Biological: VM-202

VM-202

EXPERIMENTAL

Biological: VM-202

Interventions

VM-202 BIOLOGICAL

VM202 is a DNA plasmid that contains novel genomic cDNA hybrid human hepatocyte growth factor (HGF) coding sequence (HGF-X7) expressing two isoforms of HGF, HGF 728 and HGF 723.

Placebo; VM-202

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years to 75 years;
• Documented history of Type I or II diabetes with current treatment control(glycosylated hemoglobin A1c of ≤ 10.0% at Screening) and currently on oral medication and / or insulin;
• Taking 60 to 200 mg morphine milligram equivalents (MME)/day for painful DPN at study entry and must be on stable regimen starting at Day -21; percent of overall requirement as immediate release must be ≥ 30%;
• No significant changes anticipated in diabetes medication regimen;
• No new symptoms associated with diabetes within the last 3 months prior to study entry;
• Diagnosis of painful diabetic peripheral neuropathy in both lower extremities;
• Global pain intensity \[Numerical rating scale, average NRS\] score over the week prior to initial Screening visit must be ≥ 4 and ≤ 9 (0 = no pain - 10 = worst pain imaginable);
• Symptoms from the Brief Pain Neuropathy Screening (BPNS) is ≤ 5 point difference between legs at Initial Screening;
• The physical examination component of the Michigan Neuropathy Screening Instrument Score (MNSI) is ≥ 3 at Initial Screening;
• Subjects on gabapentin (Neurontin), pregabalin (Lyrica), or duloxetine (Cymbalta) for painful DPN at study entry must be on a stable regimen of these treatments for at least 7 days prior to start of oral placebo run-in; and
• If female of childbearing potential, negative urine pregnancy test at screening and using acceptable method of birth control during the study.

You may not qualify if:

• Small fiber polyneuropathy caused by condition other than diabetes;
• Additional pain syndrome of overall greater intensity than that of DPN that, in the opinion of the investigator, would prevent assessment of DPN;
• Progressive or degenerative neurological disorder;
• Myopathy;
• Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease);
• Active infection, in the opinion of the investigator;
• Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis), in the opinion of the investigator;
• Positive HIV or HTLV at Screening;
• Active Hepatitis B or C as determined by Hepatitis B core antibody (HBcAb; IgG and IgM), antibody to Hepatitis B surface antigen (HBsAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) at Screening;
• Subjects with known immunosuppression or currently receiving immunosuppressive drugs, chemotherapy or radiation therapy;
• Stroke or myocardial infarction within last 3 months;
• Uncontrolled hypertension defined as sustained systolic blood pressure (SBP) \> 200 mmHg or diastolic BP (DBP) \> 110 mmHg at Screening;
• Subjects with a recent history (\< 5 years) of or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence for one year); subjects with family history of colon cancer in any first degree relative are excluded unless they have undergone a colonoscopy in the last 12 months with negative findings;
• Use of the following drugs / therapeutics is PROHIBITED past Day -14:
• skeletal muscle relaxants, benzodiazepines (except for stable bedtime dose),

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Translational Pain Research, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Christine N. Sang, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Translational Pain Research

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 12, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)