Status:
COMPLETED
An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Refractory Partial Seizures
Eligibility:
All Genders
20-64 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00849212
Start Date
April 1 2009
End Date
November 1 2009
Last Update
February 7 2013
Active Locations (9)
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1
Kitakyushu, Fukuoka, Japan
2
Kobe, Hyōgo, Japan
3
Kyoto, Kyoto, Japan
4
Sendai, Miyagi, Japan