CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 206 enrolled
Drug / intervention
E2007 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Age 18-65 years inclusive
  • ✓History of migraine (with or without aura) per IHS criteria, onset before age 50, present ≥12 months
  • ✓4-12 qualified migraine attacks per month during past 3 months prior to Screening and during 4-week Baseline Phase
  • ✓BMI 19-40 kg/m² inclusive
Key exclusion· 15
  • ✕Chronic daily headaches (>14 headache days per month on average during 3 months prior to Screening)
  • ✕Cluster headaches or other trigeminal autonomic cephalalgias or other primary/secondary headaches (except tension-type)
  • ✕Non-responsive to more than two classes of adequately conducted prophylactic migraine treatments
  • ✕Overuse of acute medications: triptans ≥10 days/month, ergots ≥10 days/month, NSAIDs/acetaminophen/isometheptene ≥15 days/month, opioids ≥10 days/month, or any two or more ≥15 days/month

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

Search/NCT00154063
NCT00154063Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 in Migraine Prophylaxis

Eisai Inc.·interventional·Posted Sep 12, 2005·Updated Jun 8, 2015

In Brief

A Phase 2 clinical trial evaluating E2007 and Placebo for Migraine Prophylaxis. Completed, enrolled 206 participants across 9 sites.

Detailed Summary

This was a 22-week, prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group study that included a 4-week Baseline Phase at the beginning and a 4-week single-blind placebo Safety Phase at the end of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Prophylaxis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartJan 1, 2005
Primary CompletionJun 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 20.8 years ago

Interventions

E2007drug

Placeboother