Phase 3 Gene Therapy for Painful Diabetic Neuropathy
United States507 participantsStarted 2016-04
Plain-language summary
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 peripheral neuropathy.
A total of 507 of 477 planned participants were randomized in a 2:1 ratio to one of two treatment groups. Note that 500 participants received Investigational product treatment, whereas 7 participants did not receive Investigational product treatment.
Treatments - Engensis (VM202) - 336 Engensis of 318 planned participants
Control - Placebo (VM202 vehicle) - 164 Placebo of 159 planned participants
Randomization were stratified by current use of gabapentin and/or pregabalin.
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 (HbA1c of ≤ 10.0% at Screening) and currently on medication for diabetes (oral, injectable, 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 score of ≥ 40 mm at Initial Screening (0 mm = no pain - 100 mm very severe pain)
✓. Symptoms from the Brief Pain Neuropathy Screening is ≤ 5 point difference between legs at Initial Screening
Exclusion criteria
✕. Peripheral neuropathy caused by condition other than diabetes
What they're measuring
1
Change in the Average 24 Hour Pain Score From Baseline to Day 90
Timeframe: The Pain and Sleep Interference diary was completed by participants for at least 5 assessments during a 7-day period at Screening (the mean 24-hour score was the reference/baseline score) and within 14 days prior to Day 90 visit.
2
Participants With at Least at 50 Percent Reduction in Average 24-hour Pain Score From Baseline to Day 90
Timeframe: Baseline to Day 90
3
Number of Participants With Treatment-emergent Adverse Events.