NCT03755934

Efficacy and Safety of MEDI7352 in Participants With Painful Diabetic Neuropathy

A Randomised, Double-Blind, Placebo-Controlled, Dose-Response Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a study investigating the effect of MEDI7352 on chronic pain in participants with painful diabetic neuropathy. The study incudes a screening period of up to 45 days and a 12-week treatment period during which MEDI7352 or placebo will be administered intravenously (IV) on 6 occasions, with each dose separated by 14 days. There will be a 6-week follow-up period. Participants will randomly be assigned to double-blind treatment with one of 4 dose levels of MEDI7352 or placebo.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	MEDI7352	Participants will receive IV infusion of MEDI7352 as stated in arm description.
OTHER	Placebo	Participants will receive IV infusion of placebo as stated in arm description.

Timeline

• Start date: 2018-11-19
• Primary completion: 2023-06-29
• Completion: 2023-06-29
• First posted: 2018-11-28
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

31 sites across 5 countries: Denmark, Hungary, Poland, Romania, United Kingdom

Regulatory

• FDA-regulated drug study