At a glance
ClinicalIndex Comparison Record- ✓Age 20–64 years old
- ✓Diagnosed with partial seizure, including secondarily generalized seizure
- ✓At least 3 partial seizures in the 4 weeks prior to observation start, with no seizure-free period >21 days in the 8 weeks before treatment start
- ✓Treated for ≥12 weeks with ≥2 standard AEDs for ≥2 years with inadequate seizure control
- ✕Present or history of Lennox-Gastaut syndrome
- ✕Primary generalized seizures (absence, myoclonic)
- ✕Status epilepticus within 1 year
- ✕Seizure clusters where individual seizures cannot be counted within 8 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating E2007 for Refractory Partial Seizures. Completed, enrolled 30 participants across 9 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.