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Painful Diabetic NeuropathyPhase 2NCT04087941

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

A Phase 2 study testing VM-202 in people with Painful Diabetic Neuropathy, run by Brigham and Women's Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Painful Diabetic Neuropathy
What is being tested?
VM-202
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Nov 2019to Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Specific laboratory values at Screening including: Hemoglobin < 8.0 g/dL, WBC < 3,000 cells per microliter, platelet count <75,000/mm3, Creatinine > 2.0 mg/dL; AST and/or ALT > 3 times the upper limit of normal or any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary;
  • Proliferative retinopathy within 5 years of signing consent or any ophthalmological condition which, in the opinion of the investigator, should be exclusionary; any condition that precludes standard ophthalmologic examination;
  • 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),
  • capsaicin, local anesthetic creams and patches, isosorbide dinitrate (ISDN) spray,
  • transcutaneous electrical nerve stimulation (TENS), acupuncture
  • If not using gabapentin (Neurontin), pregabalin (Lyrica), duloxetine (Cymbalta), any antidepressants (e.g., amitriptyline and venlafaxine), any other antiepileptics (e.g., valproic acid, carbamazepine, or vigabatrin), subjects must agree not to start these drugs until after Day 180. Subjects on these medications on day of informed consent must maintain a stable dose starting at Day -21 until Day 180; any changes in analgesic regimen after Day 180 are at the discretion of the investigator;
  • Use of certain COX-1/COX-2 inhibitor drug(s), steroids (except inhaled, ocular, or intra-articular steroids), and anti-Vascular Endothelial Growth Factor (VEGF) agents; subjects may be enrolled if willing/able to undergo medication wash-out prior to the first dosing and to refrain from taking these drugs for the duration of the study;
  • Major psychiatric disorder within last 6 months that would interfere with study participation;
  • Body mass index (BMI) > 45 kg/m2 at Screening;
  • Any prior or lower extremity amputation due to diabetic complications;
  • History of illicit drug or alcohol abuse / dependence in the past 2 years, including but not limited to, cocaine, amphetamines, non-prescribed opioids, and non-prescribed benzodiazepines);
  • Use of an investigational drug or treatment in past 6 months; and
  • Unable or unwilling to give informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Translational Pain Research, Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Hepatocyte Growth Factor for Opioid-Dependent Pain: Efficacy and Safety of VM202 in Painful Diabetic Peripheral Neuropathy (The HOPES Trial)

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).

Being tested
VM-202
Medical subject headings
Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VM-202Biological

    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.

Study groups in NCT04087941
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Biological: VM-202
VM-202ExperimentalNot described
Receives: Biological: VM-202

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline week to week prior to Day 180

Secondary outcomes (7)

  1. Opioid use - mean dose

    mean dose of opioid reported in 24-hour MME at each timepoint

    Measured: Day 90, Day 180, Day 270, Day 365

  2. Opioid use - percent change from baseline

    percent change from baseline in 24-hour MME during the week prior to each timepoint

    Measured: Day 90, Day 180, Day 270, Day 365

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

    percent of subjects whose daily opioid consumption is reduced by 50% and 100% (opioid-free) at each timepoint

    Measured: Day 90, Day 180, Day 270, Day 365

  4. Opioid-Related AE - Cognition

    Cognition as measured with Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) assessed at each timepoint

    Measured: Day 90, Day 180, Day 270, Day 365

  5. Opioid-Related AE - Bowel Function

    Bowel Function Inventory-revised (BFI-R) assessed at each timepoint

    Measured: Day 90, Day 180, Day 270, Day 365

  6. Opioid-Related AE - Numerical Opioid Side Effect (NOSE)

    NOSE assessed at each timepoint

    Measured: Day 90, Day 180, Day 270, Day 365

  7. Efficacy- Change in Average Pain Intensity

    the change in average pain intensity from baseline week to the week prior to Day 180 obtained from the daily eDiaries

    Measured: baseline week to week prior to Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2019
  2. Study startNov 2019 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Why it stopped: This study never left the planning stages: there was no IRB application and no participants were enrolled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04087941
Sponsor's protocol ID
HOPES
Status last verified
Nov 2025
First submitted
11 Sep 2019
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VM-202 in people with Painful Diabetic Neuropathy, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24-hour Morphine Milligram Equivalents (MME) (time frame: baseline week to week prior to Day 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04087941.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.

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