Painful Diabetic Neuropathies Clinical Trial
Official title:
A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Engensis (VM202) in Subjects With Painful Diabetic Peripheral Neuropathy
| NCT number | NCT01475786 |
| Other study ID # | VMDN-002 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | August 2012 |
| Est. completion date | June 2014 |
| Verified date | June 2023 |
| Source | Helixmith Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine if Engensis (VM202) is safe and effective in treating painful diabetic neuropathy.
| Status | Completed |
| Enrollment | 104 |
| Est. completion date | June 2014 |
| Est. primary completion date | March 12, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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 - 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 Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Sejong General Hospital | Bucheon | Sosa-gu |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Bundang-gu |
| Korea, Republic of | The Catholic University of Korea Youido St. Mary's Hospital | Seoul | Yeongdeungpo-gu |
| Korea, Republic of | Yonsei University College of Medicine Severance Hospital | Seoul | Seodaemun-gu |
| United States | The Neurosciences Institute Albany Medical College | Albany | New York |
| United States | Beth Israel Deaconess | Boston | Massachusetts |
| United States | Northwestern University | Chicago | Illinois |
| United States | Houston Neurocare | Houston | Texas |
| United States | The Methodist Hospital | Houston | Texas |
| United States | Mount Sinai Medical Center | New York | New York |
| United States | East Virginia Medical School Strelitz Diabetes Center | Norfolk | Virginia |
| United States | University of Oklahoma Harold Hamm Diabetes Center | Oklahoma City | Oklahoma |
| United States | Compass Research | Orlando | Florida |
| United States | Palm Beach Neurological Center | Palm Beach Gardens | Florida |
| United States | University of Utah | Salt Lake City | Utah |
| United States | Rainier Clinical Research | Seattle | Washington |
| United States | Diablo Clinical Research | Walnut Creek | California |
| Lead Sponsor | Collaborator |
|---|---|
| Helixmith Co., Ltd. |
United States, Korea, Republic of,
Kessler JA, Smith AG, Cha BS, Choi SH, Wymer J, Shaibani A, Ajroud-Driss S, Vinik A; VM202 DPN-II Study Group. Double-blind, placebo-controlled study of HGF gene therapy in diabetic neuropathy. Ann Clin Transl Neurol. 2015 May;2(5):465-78. doi: 10.1002/ac — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Primary Study Endpoint Was the Change in Average 24-hour Pain Score From Baseline to the 6-month Follow-up. | The difference in the mean change of the 24 hour pain score was compared between the treatment groups and the placebo arm to determine treatment effect. The average pain scores were obtained from the Daily Pain and Sleep Interference Diary (recorded daily by subjects for 7 days during Screening prior to the first round of injections and again, before the 6 month follow-up). Subjects rated their 24-hor daily pain intensity according to the 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). | seven (7) days before Day 0, Day 90, and the 6 Month and 9 Month visits |