At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
E2007 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Explore the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures
In Brief
A Phase 2 clinical trial evaluating E2007 and Placebo for Epilepsy. Completed, enrolled 48 participants across 2 sites.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, parallel group study to determine the maximum tolerated dose of E2007. Epilepsy patients with refractory partial seizures will be divided into two groups of 24 patients each. One group will be patients who take concomitant inducing AEDs (anti-epileptic drugs) and the second group will be patients who do not take concomitant inducing AEDs. In each group, 18 patients will receive E2007 (dose escalating to a maximum of 12 mg per day) and six will receive placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesLatvia
CollaboratorsEisai Limited
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedDec 2006
Primary CompletionFeb 2008
Study CompletionMar 2008
TodayJul 2026
First PostedDec 27, 2006
Enrollment StartDec 1, 2006
Primary CompletionFeb 1, 2008
Study CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.5 years ago
Interventions
E2007drug
Placebodrug