NCT00505284

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

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	Placebo	Placebo tablets, once daily, for 15 weeks (taken orally).
DRUG	E2007 (2 mg)	Perampanel, 2 mg once daily, for 15 weeks (taken orally).
DRUG	E2007 (4 mg)	Perampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally).
DRUG	E2007 (6 mg)	Perampanel, 2 mg once daily for three weeks, followed by 4 mg once daily, for three weeks and 6 mg, once daily, for nine weeks (taken orally).
DRUG	E2007 (8 mg)	Perampanel, 2 mg once daily, for three weeks, followed by 4 mg, once daily for three weeks, 6 mg once daily for three weeks and 8 mg, once daily, for six weeks (taken orally).

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-07-23
• Last updated: 2014-07-11
• Results posted: 2013-02-08

Locations

1 site across 1 country: United States