EUCTR2007-006169-33-IT进行中（未招募）不适用
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
EISAI Ltd0 个研究点目标入组 680 人开始时间: 2008年9月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 680
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
- •Confidential Page 24 of 100
- •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
排除标准
- •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
- •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
- •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;
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