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

NCT00505284 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2014-07-11

Study results available
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Summary

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

Conditions

  • Diabetic Neuropathy

Interventions

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).

Sponsors & Collaborators

  • Eisai Limited

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Antonio Laurenza, M.D. · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00505284 on ClinicalTrials.gov