NL-OMON50183撤回3 期
OPEN-LABEL, SINGLE-ARM, MULTICENTER, LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY OF BRIVARACETAM USED AS ADJUNCTIVE TREATMENT IN PEDIATRIC SUBJECTS WITH EPILEPSY;P/297/2019 (POS indication) - N01266
CB Pharma0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 4
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •To be eligible to participate in this study, all of the following criteria must
- •be met as specified. , # Inclusion criteria for all subjects, - An
- •Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
- •written Informed Consent form is signed and dated by the parent(s) or legal
- •representative(s). The Consent form or a specific Assent form, where required,
- •will be signed and dated by minors., - Subject/legal representative is
- •considered reliable and capable of adhering to the protocol (eg, able to
- •understand and complete diaries), visit schedule, or medication intake
- •(including BRV oral solution or tablets) according to the judgment of the
- •Investigator., - For female subjects, the subject is, 1) Not of childbearing
- •potential OR Of childbearing potential, and
- •- Is not sexually active
- •- Has a negative pregnancy test, OR , 2) Of childbearing potential, and Is
- •sexually active, Has a negative pregnancy test, - Understands the consequences
- •and potential risks of inadequately protected sexual activity, understands and
- •properly uses contraceptive methods, and is willing to inform the Investigator
- •of any contraception changes. Medically acceptable contraceptive methods for
- •the study include, but are not limited to:, Oral or depot contraceptive
- •treatment with at least ethinylestradiol 30*g per intake or ethinylestradiol
- •50*g per intake if also taking one of the following: carbamazepine,
- •phenobarbital, primidone, phenytoin, oxcarbazepine, St. John's Wort, or
- •rifampicin, Barrier contraception: intrauterine device, diaphragm with
- •spermicide, male or female condom with spermicide, Abstinence from sexual
- •intercourse, # Inclusion criteria for LTFU subjects only, - Male or female
- •subjects having participated in a core study with BRV with a confirmed
- •diagnosis of epilepsy and for whom a reasonable benefit from long-term
- •administration of BRV is expected., # Inclusion criteria for directly enrolled
- •subjects only, - Subject is a male or female *4 years to <17 years of age.,
- •- Subject has a clinical diagnosis of POS according to the ILAE
- •classification., - Subject has an EEG compatible with the clinical diagnosis of
- •POS. , - Subject has been observed to have uncontrolled POS after an adequate
- •course of treatment (in the opinion of the Investigator) with at least 1 AED
- •(concurrently or sequentially)., - Subject had at least 1 seizure (POS) during
- •the 3 weeks before the ScrV., - Subject is taking at least 1 AED. All AEDs need
- •to be at a stable dose for at least 7 days before the ScrV. Vagal nerve
- •stimulator stable for at least 2 weeks before the ScrV is allowed and will be
- •counted as a concomitant AED. Benzodiazepines taken more than once a week (for
- •any indication) will be considered as a concomitant AED.
排除标准
- •Subjects are not permitted to enroll in the study if any of the following
- •criteria are met as specified. , # Exclusion criteria for all subjects,
- •-Subject is a pregnant or nursing female., -Subject has severe medical,
- •neurological, or psychiatric disorders or laboratory values, which may have an
- •impact on the safety of the subject., -Subject has planned participation in any
- •clinical study of another investigational drug or device., -Subject has any
- •medical condition, which in the Investigator*s opinion, warrants exclusion.,
- •-Subject has >1.5x upper limit of normal (ULN) of any of the following:
- •alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline
- •phosphatase (ALP), or >1.0xULN total bilirubin (*1.5xULN total bilirubin if
- •known Gilbert*s syndrome)., -Subject has chronic liver disease., # Exclusion
- •criteria for LTFU subjects only, - Subject had hypersensitivity to BRV or
- •excipients or comparative drugs as stated in this protocol during the course of
- •the core study., - Subject had poor compliance with the visit schedule or
- •medication intake in the core study., - Subject *6 years of age has a lifetime
- •history of suicide attempt (including actual attempt,interrupted attempt, or
- •aborted attempt), or has suicidal ideation in the past 6 months as indicated by
- •a positive response (*Yes*) to Question 5 of the Columbia-Suicide Severity
- •Rating Scale (C-SSRS) at the EV. , If a subject has active suicidal ideation
- •without a specific plan as indicated by a positive response (*Yes*) to Question
- •4 of Columbia-Suicide Severity Rating Scale (C-SSRS) at the EV, the subject
- •should be referred immediately to a Mental Healthcare Professional and may be
- •excluded from the study based upon the Investigator*s judgment of benefit/risk
- •of continuing the subject in the study/on study medication., # Exclusion
- •criteria for directly enrolled subjects only, - Subject has previously received
- •BRV., - Subject had concomitant use of LEV at the ScrV. In addition, the use of
- •LEV is prohibited for at least 4 weeks prior to the ScrV., - Subject has
- •epilepsy secondary to a progressive cerebral disease or tumor, or any other
- •progressively neurodegenerative disease. Stable arteriovenous malformations,
- •meningiomas or other benign tumors may be acceptable according to
- •Investigator*s opinion., - Subject has a history of primary generalized
- •epilepsy., - Subject has a history of status epilepticus in the month
- •immediately prior to the ScrV or during the Up Titration Period., - Subject has
- •a history or presence of pseudoseizures., - Subject is suffering only from
- •febrile seizures., - Subject is on felbamate with less than 18 months
- •continuous exposure. Subject who has taken felbamate for a combined duration of
- •treatment and wash out of <18 months before the ScrV., - Subjects treated
- •with vigabatrin who have visual field defects., - Subject has an allergy to
- •pyrrolidone derivatives or investigational product excipients or a history of
- •multiple drug allergies., - Subject has any clinically significant acute or
- •chronic illness as determined during the physical examination or from other
- •information available to the Investigator (eg, bone marrow depression, chronic
- •hepatic disease, severe renal impairment, psychiatric disorder)., - Subject has
- •an underlying disease or is receiving a treatm
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