An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)
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|ClinicalTrials.gov Identifier: NCT00849212|
Recruitment Status : Completed
First Posted : February 23, 2009
Results First Posted : February 7, 2013
Last Update Posted : February 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Refractory Partial Seizures||Drug: E2007||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-label, Ascending High-dose, add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
The dose of E2007 will start from 2 mg and will be increased by 2 mg every week up to 12 mg (the maximum dose). The dose will be adjusted during 6 weeks (i.e., titration period). Subsequently, the dose will be fixed and maintained during 4 weeks (Maintenance period). Patients must visit study site at Weeks -4, 1, 2, 3, 4, 5, 6, 8, 10 and 14 to confirm.
- Maximum Tolerated Dose (MTD) [ Time Frame: 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.
- Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849212
|Kitakyushu, Fukuoka, Japan|
|Kobe, Hyogo, Japan|
|Sendai, Miyagi, Japan|
|Komatsushima, Tokushima, Japan|
|Kodaira, Tokyo, Japan|
|Study Director:||Hidetaka Hiramatsu||New Drug Development Department, Eisai Company Limited|