NL-OMON41449已完成3 期
AN OPEN-LABEL, MULTICENTER, FOLLOW-UP STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF BRIVARACETAM USED AS ADJUNCTIVE TREATMENT IN SUBJECTS AGED 16 YEARS OR OLDER WITH EPILEPSY - Follow-up study of Brivaracetam
CB BioSciences GmbH0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
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 99（—）
入选标准
- •To be eligible to participate in this study, all of the following criteria must be met:
- •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.
- •2. Male/female subject from 18years or older.
- •3. Subject completed the Treatment Period of N01358.
- •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 30*g per intake (or ethinylestradiol 50*g 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.
排除标准
- •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 study
- •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 study
- •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 screening.
研究者
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