An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)

Phase 2

Completed

• Conditions: Refractory Partial Seizures
• Interventions: Drug: E2007

• Registration Number: NCT00849212
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese patients with refractory partial seizures which are uncontrolled with other anti-epileptic drugs (AEDs). Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per day). The dose of E2007 will be adjusted during 6 weeks. Subsequently, the dose will be fixed and maintained during 4 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-23
• Study Start: 2009-04
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2012-10-26
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-03
• Last Update Submitted: 2013-01-03
• Results First Posted: 2013-02-07
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	E2007	-

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	10 weeks (Titration and Maintenance Periods)	MTD was defined by participants. For participants who completed treatment, MTD was dose at last administration. For subjects who discontinued due to adverse event (AE), the MTD depended on the number of days within down-titration. If these criteria were not applied, the MTD was determined based on suggestions from the Tolerability and Safety Evaluation Committee.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF	Baseline (Day -28 to Day 0), Week 1 to Week 10	The percent change in seizure frequency per 28 days during the maintenance period was collected via patient diary cards. This was calculated using the last observation carried forward (LOCF) method.