Phase 3 Gene Therapy for Painful Diabetic Neuropathy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02427464 |
Recruitment Status :
Completed
First Posted : April 28, 2015
Last Update Posted : October 18, 2019
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The purpose of this study is to determine the safety and efficacy of bilateral intramuscular injections of VM202 versus placebo in the treatment of painful diabetic neuropathy.
A total of 477 subjects will be randomized in a 2:1 ratio to one of two treatment groups:
Treatment - VM202 - 318 subjects Control - Placebo (VM202 vehicle) - 159 subjects
Randomization will be stratified by current use of gabapentin and/or pregabalin.
Condition or disease | Intervention/treatment | Phase |
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Painful Diabetic Neuropathy Diabetic Neuropathy, Painful | Biological: VM202 Other: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 507 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 in Subjects With Painful Diabetic Peripheral Neuropathy |
Study Start Date : | April 2016 |
Actual Primary Completion Date : | December 2018 |
Actual Study Completion Date : | July 2019 |

Arm | Intervention/treatment |
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Experimental: VM202
Subjects randomized to the VM202 treatment arm will receive the following intramuscular injections in each calf:
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Biological: VM202
gene therapy |
Placebo Comparator: Placebo
Subjects in the placebo control group will receive the following intramuscular injections in each calf:
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Other: placebo |
- Change in the average pain score [ Time Frame: Baseline to three month follow up ]Subjects complete a Daily Pain and Sleep Interference diary at Screening (following wash-out of prohibited medications), and Day 90
- Outcome of at least 50% reduction in average pain score [ Time Frame: Baseline to three month follow up ]Subjects complete a Daily Pain and Sleep Interference diary at Screening (following wash-out of prohibited medications), and Day 90
- Change in the average pain score [ Time Frame: Baseline to Six month follow up ]Subjects complete a Daily Pain and Sleep Interference diary at Screening (following wash-out of prohibited medications), Day 90, Day 180
- Outcome of at least 50% reduction in average pain score [ Time Frame: Baseline to Six month follow up ]Subjects complete a Daily Pain and Sleep Interference diary at Screening (following wash-out of prohibited medications), Day 90, and Day 180

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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;
- 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;
- Lower extremity pain for at least 6 months;
- Visual analog scale (VAS) score of ≥ 40 mm at Initial Screening (0 mm = no pain - 100 mm very severe pain);
- Symptoms from the Brief Pain Neuropathy Screening (BPNS) is ≤ 5 point difference between legs at Initial Screening;
- The average daily pain intensity score of the Daily Pain and Sleep Interference Diary completed after medication wash-out is ≥ 4 with a standard deviation ≤ 2;
- The physical examination component of the Michigan Neuropathy Screening Instrument Score (MNSI) is ≥ 3 at Initial Screening;
- Subjects on gabapentin (Neurontin), pregabalin (Lyrica), duloxetine (Cymbalta) for painful DPN at study entry must be on stable regimen of these treatments for at least 3 months prior to study entry; and
- If female of childbearing potential, negative urine pregnancy test at screening and using acceptable method of birth control during the study.
Exclusion Criteria:
- Peripheral neuropathy caused by condition other than diabetes;
- Other pain more severe than neuropathic pain that 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;
- Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis);
- Positive HIV or HTLV at Screening;
- Active Hepatitis B or C as determined by Hepatitis B core antibody (HBcAb), antibody to Hepatitis B surface antigen (IgG and IgM; 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;
- Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude 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;
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Use of the following drugs / therapeutics is PROHIBITED. Subjects may participate in the study if they are willing to discontinue use of these drugs / therapeutics 7 days prior to starting the 7 Day Daily Pain and Sleep Interference Diary. Subjects must refrain from taking these drugs or undergoing these therapies for the duration of the study:
- skeletal muscle relaxants, opioids, 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) or pregabalin (Lyrica), subjects must agree not to start these drugs for the first 6 months of the study. Subjects on these medications at study entry must maintain a stable dose for the first 6 months of the study;
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If not using duloxetine (Cymbalta), any antidepressants (e.g. amitriptyline and venlafaxine), any other antiepileptics (e.g., valproic acid, carbamazepine, vigabatrin), subjects must agree not to start these drugs for the first 6 months of the study.
Subjects on these medications at study entry must maintain a stable dose for the first 6 months of the study;
- Subjects requiring > 81 mg daily of acetylsalicylic acid; subjects may be enrolled if willing/able to switch to ≤ 81 mg daily of acetylsalicylic acid or to another medication;
- Subjects requiring regular COX-2 inhibitor drug(s) or non-specific COX-1/COX-2 inhibiting drugs, or high dose steroids (except inhaled steroids or ocular steroids); 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 first 6 months 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 lower extremity amputation due to diabetic complications;
- Use of an investigational drug or treatment in past 6 months, or prior participation in any study of VM202; and
- Unable or unwilling to give informed consent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427464

Principal Investigator: | John A Kessler, MD | Northwestern University |
Responsible Party: | Helixmith Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT02427464 |
Other Study ID Numbers: |
VMDN-003 |
First Posted: | April 28, 2015 Key Record Dates |
Last Update Posted: | October 18, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
diabetic neuropathy shooting pain burning pain |
pins and needles pain foot pain ViroMed |
Peripheral Nervous System Diseases Diabetic Neuropathies Pain Neuromuscular Diseases Nervous System Diseases |
Neurologic Manifestations Diabetes Complications Diabetes Mellitus Endocrine System Diseases |