MedTrace Logo

Efficacy and Safety of MEDI7352 in Participants With Painful Diabetic Neuropathy

NCT03755934 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-09-19

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2023-06-29
Completion
2023-06-29
FDA Drug
Yes

Countries

  • Denmark
  • Hungary
  • Poland
  • Romania
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03755934 on ClinicalTrials.gov