Phase 2
N=30
An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)
Refractory Partial Seizures
Bottom Line
View on ClinicalTrials.gov: NCT00849212 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Maximum Tolerated Dose (MTD) — 0; 2; 1; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- E2007 (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eisai Co., Ltd.
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
0; 2; 1; 6; 6; 5 | — |
| SECONDARY Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF |
-35 | — |
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.
Eligibility Criteria
Inclusion criteria
- Male or female aged between 20 and 64 years old.
- Patients diagnosed with partial seizure (including secondarily generalized seizure).
- Patients who have at least 3 counts of partial seizures during the previous 4 weeks prior to observation start and no seizure-free for 21 days during 8 weeks before the treatment start based on medical records. Simple partial seizure without motor signs will not be counted.
- Patients who have been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard AED for 2 years.
- Patients treated with stable doses of up to three AEDs. Only one cytochrome
P450 (CYP) 3A4 inducer shown below will be allowed for concomitant use:
- Carbamazepine
- Phenytoin
- Phenobarbital
- Primidone
- Patients on stable dose of anti-depressants, anti-anxiety drugs, or mood stabilizers from before 8 weeks.
Exclusion criteria
- Patients with present or a history of Lennox-Gastaut syndrome.
- Patients with present generalized seizures (e.g., absence, myoclonic).
- Patients with a history of status epilepticus within 1 year.
- Patients with seizure clusters where individual seizure cannot be counted within 8 weeks.
- Patients with a history of psychogenic seizure.
- Patients who underwent surgical operation for epilepsy within 2 years.
- Patients using rescue benzodiazepines at least twice in a 4-week duration within 8 weeks (if 1 or 2 doses over 24-hour period considered one-time rescue).
- Patients whose alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at enrollment in observation period exceeds 1.5-fold the upper limit of normal (ULN), but those whose ALT or AST are constantly higher than ULN, they can enroll if ALT or AST remain in 3-fold the ULN.
- Patients with significant active hematological disease; white blood cell (WBC) count </=2500/uL or neutrophil count </=1000 uL.
- Patients on anti-psychotics or who have psychotic disorder and/or psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of suicidal attempt within 2 years.
- Patients who operate heavy equipment or drive should not be recruited into the study.
Data sourced from ClinicalTrials.gov (NCT00849212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.