An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00849212
Recruitment Status : Completed
First Posted : February 23, 2009
Results First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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 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.

Condition or disease Intervention/treatment Phase
Refractory Partial Seizures Drug: E2007 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Perampanel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: E2007
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Male or female aged between 20 and 64 years old.
  2. Patients diagnosed with partial seizure (including secondarily generalized seizure).
  3. 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.
  4. Patients who have been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard AED for 2 years.
  5. 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
  6. Patients on stable dose of anti-depressants, anti-anxiety drugs, or mood stabilizers from before 8 weeks.

Exclusion criteria:

  1. Patients with present or a history of Lennox-Gastaut syndrome.
  2. Patients with present generalized seizures (e.g., absence, myoclonic).
  3. Patients with a history of status epilepticus within 1 year.
  4. Patients with seizure clusters where individual seizure cannot be counted within 8 weeks.
  5. Patients with a history of psychogenic seizure.
  6. Patients who underwent surgical operation for epilepsy within 2 years.
  7. 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).
  8. 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.
  9. Patients with significant active hematological disease; white blood cell (WBC) count </=2500/uL or neutrophil count </=1000 uL.
  10. 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.
  11. Patients who operate heavy equipment or drive should not be recruited into the study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00849212

Kitakyushu, Fukuoka, Japan
Kobe, Hyogo, Japan
Sendai, Miyagi, Japan
Komatsushima, Tokushima, Japan
Kodaira, Tokyo, Japan
Kyoto, Japan
Nagasaki, Japan
Niigata, Japan
Shizuoka, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Study Director: Hidetaka Hiramatsu New Drug Development Department, Eisai Company Limited

Responsible Party: Eisai Co., Ltd. Identifier: NCT00849212     History of Changes
Other Study ID Numbers: E2007-J081-231
First Posted: February 23, 2009    Key Record Dates
Results First Posted: February 7, 2013
Last Update Posted: February 7, 2013
Last Verified: January 2013

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms