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NCT00144690 · ClinicalTrials.gov registry record · Phase 2

E2007 Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

A Phase 2 study of Epilepsy, sponsored by Eisai.

Completed
Registry status
Phase 2
Development phase
5
Study locations

NCT00144690: Completed Phase 2 study of Epilepsy, sponsored by Eisai.

NCT00144690 is a Phase 2 study of Epilepsy that has completed, run by Eisai. The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00144690, a Phase 2 study of Epilepsy, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 2
Development phase
5
Study locations

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 Studied

Interventions

  • DRUG Placebo
  • DRUG E2007 (perampanel)

Study Locations (5)

Arkansas

  • Dept. of Neuro Surgery - Little Rock

Florida

  • USF Physicians Group - Tampa

Michigan

  • Clinical Trials - Detroit

Ohio

  • Medical College of Ohio Comprehensive Epilepsy Ctr. - Toledo

Tennessee

  • Vanderbilt University Medical Ctr. - Nashville

Trial Details

FieldValue
Start Date 2005-03
Est. Completion 2007-02
Phase Phase 2
Eisai

287 total trials

What the finished NCT00144690 record still lists

NCT00144690 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00144690 lists 5 locations in 5 states (Arkansas, Florida, Michigan).

Frequently Asked Questions

What is clinical trial NCT00144690 about?

NCT00144690 is a clinical study titled "E2007 Given as Adjunctive Therapy in Patients With Refractory Partial Seizures". 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, con...

What is the current status of trial NCT00144690?

This trial is currently completed. It is a Phase 2 study. The study started on 2005-03. Estimated completion is 2007-02.

What conditions does trial NCT00144690 study?

This clinical trial studies the following conditions: Epilepsy.

What interventions are being tested in trial NCT00144690?

The interventions under investigation include: Placebo (DRUG), E2007 (perampanel) (DRUG).

Who is sponsoring clinical trial NCT00144690?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00144690 being conducted?

This trial has 5 study locations across Arkansas, Florida, Michigan, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00144690, the US trial registry maintained by the National Library of Medicine. NCT00144690 (unsized enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.