Status:
COMPLETED
Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy
Lead Sponsor:
Helixmith Co., Ltd.
Conditions:
Painful Diabetic Neuropathies
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if Engensis (VM202) is safe and effective in treating painful diabetic neuropathy.
Detailed Description
Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries a high risk of pain, trophic changes and autonomic dysfunction. There is currently no effective treatment f...
Eligibility Criteria
Inclusion
- 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
- 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 Screening
- Stable treatment of diabetes for at least 3 months with no anticipated changes in medication regimen, and no new symptoms associated with diabetes
- If female of childbearing potential, negative urine pregnancy test at screening and using acceptable method of birth control during the study
Exclusion
- Peripheral neuropathy caused by condition other than diabetes
- Other pain more severe than neuropathic pain
- 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 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
- Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination
- 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
- Uncontrolled hypertension as defined as sustained systolic blood pressure (SBP) \> 200 mmHg or diastolic BP (DBP) \> 110 mmHg at Screening
- Patients 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); patients 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
- Subjects requiring \> 81 mg daily of acetylsalicylic acid; If ≥ 81 mg are taken at screening, subjects may be enrolled if willing/able to switch to another medication
- Use of any opioids; subjects may be enrolled if willing and able to discontinue use of these drugs 14 days prior to starting the 7 Day Daily Pain and Sleep Interference Diary and refrain from taking these drugs for the duration of the study
- Subjects requiring regular COX-2 inhibitor drug(s) or non-specific COX-1/COX-2 inhibiting drugs, or high dose steroids (excepting inhaled 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 duration of the study;
- Major psychiatric disorder in within last 6 months
- Body mass index (BMI) \> 45 kg/m2 at Screening
- Any lower extremity amputation
- Use of an investigational drug or treatment in past 6 months
- Unable or unwilling to give informed consent
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01475786
Start Date
August 1 2012
End Date
June 1 2014
Last Update
October 6 2025
Active Locations (17)
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1
Diablo Clinical Research
Walnut Creek, California, United States, 94598
2
Compass Research
Orlando, Florida, United States, 32806
3
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States, 33418
4
Northwestern University
Chicago, Illinois, United States, 60611