Phase 3 Gene Therapy for Painful Diabetic Neuropathy



Status:Active, not recruiting
Conditions:Diabetic Neuropathy, Neurology, Pain
Therapuetic Areas:Endocrinology, Musculoskeletal, Neurology
Healthy:No
Age Range:18 - 75
Updated:8/5/2018
Start Date:April 2016
End Date:June 2019

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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

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.

Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries
a high risk of pain, trophic changes and autonomic dysfunction. Treatment of diabetic
peripheral neuropathy (DPN) is based on either pathogenetic mechanisms or symptomatic relief.
A number of clinical trials have established symptomatic treatment but for pathogenetic
mechanisms, the only proven treatment strategy is strict glycemic control. Clearly, it would
be desirable to prevent, impede, or reverse the disrupting and often life-threatening
manifestations of peripheral neuropathy by stimulating growth or regeneration of peripheral
nerve axons. The results from previous studies suggest that VM202 provides the same magnitude
of pain relief as reported with pregabalin or gabapentin.

Inclusion Criteria:

1. Age ≥ 18 years to 75 years;

2. 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;

3. No significant changes anticipated in diabetes medication regimen;

4. No new symptoms associated with diabetes within the last 3 months prior to study
entry;

5. Diagnosis of painful diabetic peripheral neuropathy in both lower extremities;

6. Lower extremity pain for at least 6 months;

7. Visual analog scale (VAS) score of ≥ 40 mm at Initial Screening (0 mm = no pain - 100
mm very severe pain);

8. Symptoms from the Brief Pain Neuropathy Screening (BPNS) is ≤ 5 point difference
between legs at Initial Screening;

9. 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;

10. The physical examination component of the Michigan Neuropathy Screening Instrument
Score (MNSI) is ≥ 3 at Initial Screening;

11. 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

12. If female of childbearing potential, negative urine pregnancy test at screening and
using acceptable method of birth control during the study.

Exclusion Criteria:

1. Peripheral neuropathy caused by condition other than diabetes;

2. Other pain more severe than neuropathic pain that would prevent assessment of DPN;

3. Progressive or degenerative neurological disorder;

4. Myopathy;

5. Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's
disease);

6. Active infection;

7. Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis);

8. Positive HIV or HTLV at Screening;

9. 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;

10. Subjects with known immunosuppression or currently receiving immunosuppressive drugs,
chemotherapy or radiation therapy;

11. Stroke or myocardial infarction within last 3 months;

12. 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;

13. Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that
preclude standard ophthalmologic examination;

14. Uncontrolled hypertension defined as sustained systolic blood pressure (SBP) > 200
mmHg or diastolic BP (DBP) > 110 mmHg at Screening;

15. 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;

16. 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

17. 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;

18. 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;

19. 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;

20. 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;

21. Major psychiatric disorder within last 6 months that would interfere with study
participation;

22. Body mass index (BMI) > 45 kg/m2 at Screening;

23. Any lower extremity amputation due to diabetic complications;

24. Use of an investigational drug or treatment in past 6 months, or prior participation
in any study of VM202; and

25. Unable or unwilling to give informed consent.
We found this trial at
25
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Renton, Washington 98057
Principal Investigator: Leslie Klaff, MD
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Christine N. Sang, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Jeffrey Allen, MD
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Principal Investigator: Judith L. White, MD
Phone: 407-426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Senda Ajroud-Driss, MD
Phone: 312-503-7504
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Clearwater, Florida 33756
Principal Investigator: Miguel Trevino, MD
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Everett, Washington 98208
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Fairfield, Connecticut 06824
Principal Investigator: Thomas Toothaker, MD
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Gainesville, Florida 32610
Principal Investigator: James Wymer, MD
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Houston, Texas 77030
Principal Investigator: Aziz Shaibani, MD
Phone: 713-795-0033
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653 8th Street West
Jacksonville, Florida 32207
Principal Investigator: Joe Chehade, MD
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Kansas City, Kansas
Principal Investigator: Mazen Dimachkie, MD
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Little Rock, Arkansas 72205
Principal Investigator: Victor Biton, MD
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Los Gatos, California 95032
Principal Investigator: Richard S Cherlin, MD
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New York, New York 10032
Principal Investigator: Thomas Brannagan, MD
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855 West Brambleton Avenue
Norfolk, Virginia 23510
Principal Investigator: Aaron I Vinik, MD
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Phoenix, Arizona 85023
Principal Investigator: Joseph S Gimbel, MD
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Raleigh, North Carolina 27607
Principal Investigator: Michael Bowman, MD
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Sacramento, California
Principal Investigator: Douglas Young, MD
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65 Mario Capecchi Drive
Salt Lake City, Utah 84112
Principal Investigator: Gordon Smith, MD
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San Francisco, California 94115
Principal Investigator: Alexander Reyzelman, DPM
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Santa Monica, California 90404
Principal Investigator: David Kudrow, MD
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5115 North Armenia Avenue
Tampa, Florida 33603
Principal Investigator: Lon D. Lynn, DO
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Walnut creek, California 94598
Principal Investigator: Mark Christiansen, MD
Phone: 925-930-7267
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York, Pennsylvania 17403
Principal Investigator: Maria Kasper, DPM
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