EUCTR2011-004109-25-DE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 350 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
- 350
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. 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,
- •who is 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 of the subject, or a person who provides daily care to the
- •subject 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
- •5. Subject has a documented history of seizure clusters that includes all
- •the following:
- •a. The subject's seizure cluster pattern is observable, stereotyped, and
- •recognizably different from the subject's other non-cluster seizure
- •activity (if any) in seizure type, duration, severity, or frequency, and of
- •the same type that was approved by the central reviewer in study P261-
- •b. A documented history of seizure clusters lasting a minimum of 10
- •minutes from the time the seizure cluster is recognized.
- •c. As part of the subject's stereotyped seizure cluster pattern, a second
- •seizure typically
- •occurs within 6 hours from the time of recognition of the seizure cluster.
- •d. The subject's stereotyped seizure cluster pattern is composed of
- •multiple (=2) partial or
- •generalized seizures.
- •e. The subject's stereotyped seizure cluster pattern was established > 3
- •months before Visit
- •1 of study P261-401.
- •f. A frequency of =3 stereotyped seizure clusters during the year before
- •Visit 1 of study P261-401.
- •g. At least 1 stereotyped seizure cluster occurring at least once in the 4
- •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
- •a. Is the subject a male?
- •b. Is the subject a postmenopausal female as determined in study P261-
- •c. Is the subject a female who has written medical documentation of
- •being permanently sterilized (e.g. hysterectomy, double oophorectomy,
- •bilateral salpingectomy)?
- •d. Has the subject agreed to use two effective methods of contraception
- •during the entire
- •study if she is sexually active or will become sexually active during the
- •study (except where local law or regulation differs; approval by USL or
- •designee is required in such cases)?
- •Examples of two effective methods of contraception include the
- 另有 9 项未显示
排除标准
- •1. Subject experienced status epilepticus during or since the P261-401 study.
- •2. Subject has a positive pregnancy test at any visit 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 on average.
- •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 with baseline room air oxygen saturations < 90%, New York Heart Association class
- •III or IV functional status, 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 suicidality, defined as any of the following: a) active suicidal plan/intent or active suicidal thoughts during or since the P261-
- •401 study as defined by a Columbia-Suicide Severity Rating Scale (CSSRS) suicidal ideation score =3, b) any suicide attempt during or since
- •the P261-401 study as determined by the C-SSRS or medical history, or c) other clinically significant suicidality as determined by the investigator.
- •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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