PER-024-09已完成未知
A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PFIZER S.A.,
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •Subjects (male or female) must be> 18 years of age and have a diagnosis of epilepsy with partial seizures according to the definition given in the classification of epileptic seizures of the International League Against Epilepsy {International League Against Epilepsy, ILAE). Partial seizures can be simple or complex, with or without secondary tonic-clonic generalization.
- •Subjects must have epilepsy diagnosed at least 2 years before, and not have responded to treatment with at least two, but not more than five, previous antiepileptic drugs (FAE), and be receiving stable doses of 1 or 2 standard FAE in the Recruitment moment for the study.
- •They should have had a 12-lead electrocardiogram (ECG) with no clinical significance findings before randomization.
- •The subjects must have undergone an MRI or computed tomography with contrast of the brain that has not shown a progressive structural abnormality of the central nervous system at the time of diagnosis of epilepsy.
- •Women of childbearing age should follow an effective method of contraception during the study. They must also have a negative pregnancy test before being included in the study.
- •During the baseline period of 6 weeks, subjects should suffer a minimum of four partial seizures, without a period of 28 days free of partial seizures with or without secondary generalization. A caregiver or witness must be with the subject for a sufficient time to chronicle the appearance of epileptic seizures. These crises must have been documented in the subject´s diary.
- •Subjects undergoing an electroencephalographic test (EEG) in the 2 years prior to randomization. EEG abnormalities must be compatible with a diagnosis of focal onset epilepsy;
- •The signed and dated informed consent will be obtained from all subjects (only those who are able to give it) in accordance with local administrative and legal requirements
- •Subjects willing to comply with scheduled visits, treatment plan, clinical analyzes and other trial procedures and able to do so. Subjects who are willing to participate, but need help to answer the questionnaires, may be considered acceptable, but each case will be discussed first with e! Pfizer monitor before performing any test or screening procedure for the study.
排除标准
- •Pregnant, lactating or planning to become pregnant women during the course of the trial will be excluded:
- •Subjects with another neurological disease that may disturb the assessment of the parameters, or subjects with Lennox-Gastaut syndrome, absence crisis, status epilepticum in the 12 months prior to entry into the study or with due crisis will be excluded to a medical condition or underlying metabolic syndrome.
- •Subjects with liver disease of clinical importance or with a calculated creatinine clearance <60 ml / min will be excluded.
- •Subjects with a history of retinal abnormalities or treatment with retinotoxic agents will be excluded. See section 5.5.
- •Subjects with a history of lack of response to levetiracetam or pregabalin or hypersensitivity or poor tolerability to levetiracetam, gabapentin or pregabalin will be excluded.
- •Use of the prohibited drugs listed in this protocol in the absence of the appropriate washing phase, or probability that treatment with drugs not allowed by the study protocol is required during the study period.
- •Participation in any other study with products marketed or under investigation, simultaneously or in the 30 days prior to inclusion in the study.
- •Prior use of levetiracetam (less than one month), gabapentin or pregabalin in the 30 days prior to randomization, or probability of receiving these treatments during the study period.
- •Any other serious acute or chronic medical or psychiatric process or laboratory abnormality that may increase the risk associated with participation in the trial or administration of the product under investigation or interfere with the interpretation of the test results and which, in the opinion of the researcher, make the inclusion of the subject in this trial inappropriate.
- •Any patient in whom pregabalin or levetiracetam treatment is not appropriate according to the corresponding local technical sheet.
- •In the opinion of the investigator, the subject is unable or unlikely to follow the protocol or administration of the drug, or may not be eligible for the study for other reasons.
- •In the opinion of the researcher, the subject is unable to understand the nature, scope, procedures and possible consequences of the study or there is evidence of an attitude of lack of cooperation
研究者
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