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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Unnamed facility
Kitakyushu, Fukuoka, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Kyoto, Kyoto, Japan
Unnamed facility
Sendai, Miyagi, Japan
Maximum Tolerated Dose (MTD)
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.
Time frame: 10 weeks (Titration and Maintenance Periods)
Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF
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.
Time frame: Baseline (Day -28 to Day 0), Week 1 to Week 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Nagasaki, Nagasaki, Japan
Unnamed facility
Niigata, Niigata, Japan
Unnamed facility
Shizuoka, Shizuoka, Japan
Unnamed facility
Komatsushimachō, Tokushima, Japan
Unnamed facility
Kodaira, Tokyo, Japan