CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 352 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
E2007 (2 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00505284
NCT00505284Phase 3Completed

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

Eisai Inc.·interventional·Posted Jul 23, 2007·Updated Jul 11, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo, E2007 (2 mg), and 3 other interventions for Diabetic Neuropathy. Completed, enrolled 352 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsEisai Limited

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 23, 2007
Enrollment StartJun 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.9 years ago

Interventions

Placebodrug

Placebo tablets, once daily, for 15 weeks (taken orally).

E2007 (2 mg)drug

Perampanel, 2 mg once daily, for 15 weeks (taken orally).

E2007 (4 mg)drug

Perampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally).

E2007 (6 mg)drug

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).

E2007 (8 mg)drug

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).