計劃書編號N01379
2011-03-01 - 2018-12-31
Phase III
終止收納4
ICD-10G40.001
有關侷限(局部)(部份)特發性癲癇及癲癇症候群伴有侷限性發作，非難治之癲癇，伴有癲癇重積狀態
ICD-10G40.009
有關侷限(局部)(部份)特發性癲癇及癲癇症候群伴有侷限性發作，非難治之癲癇，未伴有癲癇重積狀態
ICD-10G40.101
有關侷限(局部)(部份)症狀性癲癇及癲癇症候群伴有單純型部份發作，非難治之癲癇，伴有癲癇重積狀態
ICD-10G40.109
有關侷限(局部)(部份)症狀性癲癇及癲癇症候群伴有單純型部份發作，非難治之癲癇，未伴有癲癇重積狀態
ICD-9345.50
部份癲癇，未提及意識障礙及難治之癲癇
一個開放標示、多中心設計的追蹤試驗，以評估 Brivaracetam 在 16 歲或16歲以上的癲癇受試者中被用作輔助療法的長期安全性和療效
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試驗申請者
保瑞爾生技股份有限公司
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試驗委託 / 贊助單位名稱
UCB BIOSCIENCES Inc.
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臨床試驗規模
多國多中心
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更新日期
2025/08/20
試驗主持人及試驗醫院
適應症
partial onset seizures
試驗目的
Primary objective
• The primary objective is to evaluate the long-term safety and tolerability of BRV at individualized doses up to a maximum of 200mg/day in epilepsy subjects.
Secondary objective
• To evaluate the maintenance of efficacy of BRV over time
Exploratory objectives
• To explore the effects of BRV on subjects’ HRQoL
• To explore direct medical resource use
• To explore any change in socio-professional status
• To assess the role of gene variants of SV2 in affecting response to BRV (
藥品名稱
Brivaracetam
主成份
(2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide
劑型
Oral film-coated tablet
劑量
10 mg、25mg、50mg
評估指標
The following primary efficacy variable will be summarized with descriptive statistics.
The primary efficacy variable is the POS (type I) seizure frequency standardized to a
28-day duration. The primary efficacy variable will be summarized by 3-month periods
over the Evaluation Period.
The following secondary efficacy variables will be summarized with descriptive statistics.
Seizure frequency per 28 days for all seizure types (I+II+III) by 3-month periods over the
Evaluation Period
Proportion of seizure-free days for all seizure types (I+II+III) by 3-month periods over
the Evaluation Period
Proportion of continuously seizure free subjects for all seizure types (I+II+III) by
3-month periods over the Evaluation Period
Responder rate in POS (type I) by 3-month periods over the Evaluation Period. A
responder is defined as a subject with a ≥50% reduction in seizure frequency from the
Baseline Period for the double-blind study N01358.
The primary efficacy variable is the POS (type I) seizure frequency standardized to a
28-day duration. The primary efficacy variable will be summarized by 3-month periods
over the Evaluation Period.
The following secondary efficacy variables will be summarized with descriptive statistics.
Seizure frequency per 28 days for all seizure types (I+II+III) by 3-month periods over the
Evaluation Period
Proportion of seizure-free days for all seizure types (I+II+III) by 3-month periods over
the Evaluation Period
Proportion of continuously seizure free subjects for all seizure types (I+II+III) by
3-month periods over the Evaluation Period
Responder rate in POS (type I) by 3-month periods over the Evaluation Period. A
responder is defined as a subject with a ≥50% reduction in seizure frequency from the
Baseline Period for the double-blind study N01358.
主要納入條件
Inclusion criteria
1. An Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approved
written informed consent signed and dated by the subject or by parent(s) or legally
acceptable representative. The consent form or a specific assent form, where required,
will be signed and dated by minors. In countries and sites where a DNA analysis is
accepted, an additional Informed Consent form will have to be signed by subjects coming
from N01358. Deoxyribonucleic acid analysis will be performed only in adults, and the
subject can withdraw consent to the use of the sample at any time. Mentally impaired
subjects will be excluded. In case the consent is withdrawn, the site must request the
destruction of the sample.
2. Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted.
3. Subject completed the Treatment Period of N01358 or the Evaluation Period of N01258.
4. Subject for whom the Investigator believes a reasonable benefit from the long-term
administration of BRV may be expected.
5. Female subject without childbearing potential (premenarcheal, postmenopausal for at
least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are
eligible. Female subject with childbearing potential are eligible if they use a medically accepted contraceptive method. Oral or depot contraceptive treatment with at least ethinylestradiol 30μg per intake (or ethinylestradiol 50μg per intake if associated with any strong enzyme inducer [eg, carbamazepine, phenobarbital, primidone, phenytoin, oxcarbazepine, St. John’s Wort, rifampicin]), monogamous relationship with
vasectomized partner, or double-barrier contraception are acceptable methods. The
subject must understand the consequences and potential risks of inadequately protected
sexual activity, be educated about and understand the proper use of contraceptive
methods, and undertake to inform the Investigator of any potential change in status.
Abstinence will be considered as an acceptable method of contraception if the
Investigator can document that the subject agrees to be compliant.
6. Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol (eg, able to understand and complete diaries and questionnaires), visit schedule, or medication intake according to the judgment of the Investigator.
Exclusion criteria
Subjects are not permitted to enroll in the study if any of the following criteria is met:
1. Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
2. Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
3. Poor compliance with the visit schedule or medication intake in the previous BRV studies
4. Planned participation in any other clinical study of another investigational drug or device during this study
5. Pregnant or lactating woman
6. Any medical condition which, in the Investigator’s opinion, warrants exclusion
7. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the Entry Visit
1. An Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approved
written informed consent signed and dated by the subject or by parent(s) or legally
acceptable representative. The consent form or a specific assent form, where required,
will be signed and dated by minors. In countries and sites where a DNA analysis is
accepted, an additional Informed Consent form will have to be signed by subjects coming
from N01358. Deoxyribonucleic acid analysis will be performed only in adults, and the
subject can withdraw consent to the use of the sample at any time. Mentally impaired
subjects will be excluded. In case the consent is withdrawn, the site must request the
destruction of the sample.
2. Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted.
3. Subject completed the Treatment Period of N01358 or the Evaluation Period of N01258.
4. Subject for whom the Investigator believes a reasonable benefit from the long-term
administration of BRV may be expected.
5. Female subject without childbearing potential (premenarcheal, postmenopausal for at
least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are
eligible. Female subject with childbearing potential are eligible if they use a medically accepted contraceptive method. Oral or depot contraceptive treatment with at least ethinylestradiol 30μg per intake (or ethinylestradiol 50μg per intake if associated with any strong enzyme inducer [eg, carbamazepine, phenobarbital, primidone, phenytoin, oxcarbazepine, St. John’s Wort, rifampicin]), monogamous relationship with
vasectomized partner, or double-barrier contraception are acceptable methods. The
subject must understand the consequences and potential risks of inadequately protected
sexual activity, be educated about and understand the proper use of contraceptive
methods, and undertake to inform the Investigator of any potential change in status.
Abstinence will be considered as an acceptable method of contraception if the
Investigator can document that the subject agrees to be compliant.
6. Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol (eg, able to understand and complete diaries and questionnaires), visit schedule, or medication intake according to the judgment of the Investigator.
Exclusion criteria
Subjects are not permitted to enroll in the study if any of the following criteria is met:
1. Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
2. Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
3. Poor compliance with the visit schedule or medication intake in the previous BRV studies
4. Planned participation in any other clinical study of another investigational drug or device during this study
5. Pregnant or lactating woman
6. Any medical condition which, in the Investigator’s opinion, warrants exclusion
7. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the Entry Visit
試驗計畫預計收納受試者人數
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台灣人數
38 人
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全球人數
900 人
