EUCTR2011-004109-25-ES进行中（未招募）1 期
An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters
psher-Smith Laboratories, Inc.0 个研究点目标入组 161 人开始时间: 2012年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 161
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
入选标准
- •1. Subject or subject?s legally acceptable representative (LAR) has provided written informed consent, and subject has provided written assent where required by local law or Institutional Review Board (IRB) / Independent Ethics Committee (IEC) policy.
- •2. Subject has a competent, adult (age ?18 years) caregiver(s) who is able to recognize and observe the subject?s seizure cluster episodes, willing to be trained in the study procedures, and has provided written informed consent; the caregiver(s) must be a relative, partner, friend, or LAR who has a significant personal relationship with the subject.
- •3. Subject is between 14 and 66 years of age, inclusive, at Visit 1.
- •4. Subject has an established diagnosis of partial or generalized epilepsy.
- •5. Subject has a documented history of seizure clusters, with a pattern that is observable, stereotyped, and recognizably different from the subject?s other non-cluster seizure activity; subject?s seizure clusters must:
- •a. be of the same type that was approved by the central reviewer in study P261-401.
- •b. last at least 10 minutes after being recognized as a seizure cluster.
- •c. last no more than 6 hours.
- •d. be composed of multiple (?2) partial or generalized seizures.
- •e. be established > 3 months before Visit 1 of study P261-401.
- •f. have occurred ?4 times in the year before Visit 1 of study P261-401.
- •g. have occurred at least once in the 3 months before Visit 1 of study P261-401.
- •6. Subject has successfully completed study P261-401 and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator.
- •7. Subject is not likely to conceive, as indicated by a ?yes? answer to at least 1 of the following questions:
- •a. Is the subject a male?
- •b. Is the subject a postmenopausal female as determined in Study P261-401?
- •c. If sexually active or will become sexually active during the study, has the subject agreed to use an acceptable, double method of contraception during the entire study (except
- •where local law or regulation differs; approval by USL or designee is required in such cases)?
- •Examples of acceptable methods of contraception include the following:
- •- A diaphragm with a condom.
- •- An intrauterine device (IUD) with spermicide.
- •- Hormonal methods (eg, high-dose birth control pills, Depo-Provera), an IUD or surgical sterilization (tubal ligation, etc.) used in combination with a barrier method (condom, diaphragm, or cervical cap).
- •Note that hormonal contraception alone is not considered adequate for this study and must be used in combination with another method. The type of birth control used must be approved by the investigator or designee.
- •8. Subject?s weight is 50 kg to 125 kg, inclusive, at Visit 1.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 155
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Subject experienced status epilepticus during or since the P261-401 study.
- •2. Subject has a positive pregnancy test at Visit 1 or is pregnant, considering becoming pregnant, or is breastfeeding (female subjects only).
- •3. Subject who, in the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating in the study.
- •4. Subject has consumed any clinically significant CYP450 3A inhibitor/inducer, opioid, or other respiratory depressant, not including antiepileptic drugs (AEDs), within the required washout period before Visit 1
- •5. Subjects using chronic benzodiazepine(s); chronic use is defined as use for 4 or more days in a 7-day period.
- •6. Subject has a neurological disorder that is likely to progress in the next year.
- •7. Subject has a history of acute narrow-angle glaucoma.
- •8. Subject has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy.
- •9. Subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen.
- •10. Subject has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study.
- •11. Subject has active suicidal plan or intent as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1 or medical history.
- •12. Subject, in the investigator?s opinion, has met the criteria for a major depressive episode during or since the P261-401 study (criteria defined by the current edition of the Diagnostic and Statistical Manual of Mental Disorders).
- •13. Subject has or has had psychosis during or since the P261-401 study, excluding postictal psychosis
- •14. Subject has a history of drug or alcohol abuse during or since study P261-401.
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