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E2007 Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

NCT00144690 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-11-03

No results posted yet for this study

Summary

The primary objective of this study is to determine the maximal tolerated dose (MTD) of E2007 given twice daily (bid) or once a day (qd) in patients with refractory partial-onset seizures (including secondarily generalized seizures). The secondary objectives are to evaluate the safety, efficacy, concentration-efficacy relationship, and pharmacokinetics of E2007 and the effects of E2007 on the Profile of Mood States (POMS) test.

Conditions

Interventions

DRUG

E2007 (perampanel)

DRUG

Placebo

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Santiago Arroyo, M.D., Ph.D. · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00144690 on ClinicalTrials.gov