Randomized Phase 2 Trial of Levagen Supplement for Treating Symptoms of Diabetic Peripheral Neuropathy in Adults

What this Trial Is About

Researchers are evaluating the effects of Levagen supplementation on symptoms of diabetic peripheral neuropathy DPN in adults aged 18 to 75 years with this condition. This Phase 2 clinical trial aims to determine how Levagen impacts neuropathic pain and other related health measures over a 12-week period. The study compares Levagen to a placebo to assess its potential benefits for people with DPN. Participants will be randomly assigned to take either Levagen capsules or placebo capsules twice daily with water after food. Each Levagen capsule contains 150 mg of palmitoylethanolamide PEA, totaling 300 mg daily. The placebo capsules contain microcrystalline cellulose. The treatment period lasts 12 weeks, during which participants attend remote visits every 3 weeks and visit a local pathology center for blood draws. During the study, participants will be monitored for changes in neuropathic pain severity, symptom inventories, safety through adverse event reporting and lab markers, vital signs, sleep quality, mood, glycemic control, body measurements, and rescue medication use. Assessments occur from baseline through week 12. The trial includes detailed safety and efficacy measurements to understand the effects of Levagen on diabetic peripheral neuropathy symptoms.

Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy