Efficacy and Safety of VM202 in Painful Diabetic Peripheral Neuropathy -The HOPES Trial (NCT04087941) | Clinical Trial Compass
WithdrawnPhase 2
Efficacy and Safety of VM202 in Painful Diabetic Peripheral Neuropathy -The HOPES Trial
Stopped: This study never left the planning stages: there was no IRB application and no participants were enrolled.
United States0Started 2019-11
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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;
✓. 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;
✓. 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;
Exclusion criteria
✕. 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;
What they're measuring
1
Change in 24-hour Morphine Milligram Equivalents (MME)