A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007(perampanel) Given as Adjunctive Therapy in Subjects withRefractory Partial Seizures - ND

• Conditions: epilepsy; MedDRA version: 9.1Level: LLTClassification code 10065336Term: Partial epilepsy

• Registration Number: EUCTR2007-006169-33-IT
• Lead Sponsor: EISAI Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-26
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

1. Provide written informed consent signed by the subject or legal guardian prior to entering
the study or undergoing any study procedures (If the written informed consent is
provided by the legal guardian because the subject is unable to do so, a written or verbal
assent from the subject must also be obtained.);
2. Be considered reliable and willing to be available for the study period and is able to
record seizures and report AEs them self or have a caregiver who can record seizures and
report AEs for them;
3. Male or female and greater than or equal to 12 years of age (within the course of the
study);
4. Females should be either of non-childbearing potential (defined as having undergone
surgical sterilization, or postmenopausal [age 50 and amenorrheic for 12 months]) or of
childbearing potential. Females of childbearing potential must have a negative serum ßhCG
at Visit 1 and a negative urine pregnancy test prior to randomization at Visit 2.
Female subjects of childbearing potential must agree to be abstinent or to use at least
1 medically acceptable methods of contraception (eg, a double-barrier method [eg,
condom + spermicide, condom + diaphragm with spermicide], IUD, or have a
vasectomised partner) starting at Visit 1 and throughout the entire study period and for
2 months after the last dose of study drug. Those women using hormonal contraceptives
must also be using an additional approved method of contraception (as described
previously) starting at Visit 1 and continuing throughout the entire study period and for
2 months after the last dose of study drug. (It is not required for male subjects to use
contraceptive measures based on preclinical toxicology data provided in Section 1.3.)
5. Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized
seizures according to the International League Against Epilepsy?s Classification of
Epileptic Seizures (1981) (Appendix 5). Diagnosis should have been established by
clinical history and an electroencephalogram (EEG) that is consistent with localizationrelated
epilepsy; normal interictal EEGs will be allowed provided that the subject meets
the other diagnosis criterion (ie, clinical history).
6. Have had a computed tomography (CT) or magnetic resonance imaging (MRI) within the
last 10 years that ruled out a progressive cause of epilepsy;
perampanel Eisai Medical Research, Inc. and Eisai Limited
Clinical Study Protocol: E2007-G000-306 12 February 2008
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7. Have uncontrolled partial seizures despite having been treated with at least 2 different
AEDs within approximately the last 2 years;
8. During the 6-week Pre-randomization Phase subjects must have had ≥5 partial seizures
per 6-week (with ≥2 partial seizures per each of 3-week period) and with no 25-day
seizure-free period in the 6-week period, as documented via a valid seizure diary. Only
simple partial seizures with motor signs, complex partial seizures, and complex partial
seizures with secondary generalization are counted toward this inclusion;
9. Are currently being treated with stable doses of 1, 2 or a maximum of 3 approved AEDs.
Only 1 inducer AED (defined as; carbamazepine, phenytoin, phenobarbital, or primidone
only) out of the maximum of 3 AEDs is allowed;
10. Are on a stable dose of the same concomitant AED(s) for 1 month (or no less than
21 days) prior to Visit 1; in the case where a new AED regime has been initiated for a
subject, the dose must be stable

Exclusion Criteria

1. Participated in a study involving administration of an investigational compound or device
within 1 month (or no less than 21 days) prior to Visit 1, or within approximately 5 halflives
of the previous investigational compound, whichever is longer;
2. Pregnant and/or lactating;
3. Participated in previous perampanel studies;
4. Presence of nonmotor simple partial seizures only;
5. Presence of primary generalized epilepsies or seizures, such as absences and or
myoclonic epilepsies;
6. Presence or previous history of Lennox-Gastaut syndrome;
7. A history of status epilepticus within approximately 12 months prior to Visit 1;
8. Seizure clusters where individual seizures cannot be counted;
9. A history of psychogenic seizures;
10. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal
disease) that in the opinion of the Investigator(s) could affect the subject?s safety or the
study conduct;
11. Scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1;
however those who have previously documented ?failed? epilepsy surgery will be
allowed;
12. Evidence of significant active hepatic disease. Stable elevations of liver enzymes, alanine
aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if they are less than 3 times the upper limit of normal
(ULN);
13. Evidence of significant active hematological disease; white blood cell (WBC) count
≤ 2500/µL (2.50 1E+09/L) or an absolute neutrophil count ≤ 1000/µL (1.00 1E+09/L);
14. A clinically significant ECG abnormality, including prolonged QT defined as >450 msec;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified