An Evaluation of the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy

Diabetic Neuropathy Clinical Trial

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, parallel-group study. This is a 5-arm, 21-week study comprised of up to a 2-week Screening period, a 15-week Dose-Escalation and Maintenance Phase using 4 doses of E2007 (2 mg, 4 mg, 6 mg, and 8 mg) or placebo, and a 4-week, single-blind placebo Follow-Up Phase. Patients will be randomly assigned to one of the five treatment groups. Those patients assigned to receive either 4 mg, 6 mg, or 8 mg E2007 will be escalated to the appropriate dose according to an escalation schedule. All patients will take four identical-looking tablets on a daily basis for the entire study duration for blinding purposes. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

• NCT number: NCT00505284
• Study type: Interventional
• Source: Eisai Inc.
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2007
• Completion date: July 2008