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NCT00592774 · ClinicalTrials.gov registry record · Phase 2

Dose-Tolerability Titration Study to Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)

A Phase 2 study of Neuralgia, sponsored by Eisai.

Completed
Registry status
Phase 2
Development phase
146
Enrollment target
20
Study locations

NCT00592774: Completed Phase 2 study of Neuralgia, sponsored by Eisai.

NCT00592774 is a Phase 2 study of Neuralgia that has completed, run by Eisai. The registered enrollment target is 146 participants, above the 69-participant average among 5 other Neuralgia trials with a reported enrollment target (112% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00592774, a Phase 2 study of Neuralgia, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 2
Development phase
146 participants
Enrollment target
20
Study locations

Study Summary

The purpose of the study is to determine the efficacy and safety of Perampanel (E2007) in patients with Post-Herpetic Neuralgia (PHN).

Primary Outcome

Average pain scores are based on pain intensity (11-point Likert-type numerical scale, where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG E2007 (perampanel)

Study Locations (20)

Florida

  • - Boca Raton
  • - Bradenton
  • - Daytona Beach
  • - Delray Beach
  • - Fort Lauderdale
  • - Fort Myers
  • - Kissimmee
  • - Largo
  • - Miami
  • - Naples

California

  • - Los Angeles
  • - Sacramento
  • - San Diego
  • - San Francisco

Arizona

  • - Peoria
  • - Tucson

Colorado

  • - Boulder
  • - Denver

Arkansas

  • - Little Rock

Connecticut

  • - Milford

Trial Details

FieldValue
Enrollment Target 146 participants
Start Date 2008-01
Est. Completion 2009-03
Phase Phase 2
Eisai

287 total trials

What the finished NCT00592774 record still lists

NCT00592774 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 69-participant average among 5 other Neuralgia trials with a reported enrollment target (112% higher).

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

NCT00592774 names 20 study sites across 6 states, led by Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT00592774 about?

NCT00592774 is a clinical study titled "Dose-Tolerability Titration Study to Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)". The purpose of the study is to determine the efficacy and safety of Perampanel (E2007) in patients with Post-Herpetic Neuralgia (PHN).

What is the current status of trial NCT00592774?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 146 participants. The study started on 2008-01. Estimated completion is 2009-03.

What conditions does trial NCT00592774 study?

This clinical trial studies the following conditions: Neuralgia.

What interventions are being tested in trial NCT00592774?

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

Who is sponsoring clinical trial NCT00592774?

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

Where is trial NCT00592774 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT00592774, the US trial registry maintained by the National Library of Medicine. NCT00592774 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.