Efficacy and Safety of MEDI7352 in Participants With Painful Diabetic Neuropathy
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.
Timeline
- Start
- 2018-11-19
- Primary completion
- 2023-06-29
- Completion
- 2023-06-29
Outcome
Met primary endpoint
Stopped: “The study was prematurely terminated due to longer enrolment time than was anticipated.”
registry analysis (superiority test); Placebo vs MEDl7352 Low Dose; p = 0.0437; LS mean estimate -1.96 (95% CI -3.87 to -0.06) NCT03755934 ↗
registry analysis (superiority test); Placebo vs MEDI7352 High Dose; p = 0.0009; LS mean estimate -1.39 (95% CI -2.19 to -0.58) NCT03755934 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MEDI7352 | Unknown | — | Intravenous |