NCT03532516No Longer Available不适用
Compassionate Use Program With Brivaracetam for the Treatment of Patients With Epilepsy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
This Compassionate Use Program (CUP) is setup to provide study patients with continuous access to Brivaracetam (BRV) for the time period between closures of the long-term follow up studies N01125, N01199, N01372, N01379, and N01315 and when BRV is commercially available.
详细描述
The Expanded Access program was not conducted and is not intended to be conducted in the United States.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with epilepsy who are participating in Brivaracetam (BRV) studies N01125, N01199, N01372, N01379 or N01315
- •Patients for whom the treating physician believes there is a continued benefit from the long-term administration of BRV and other anti-epileptic therapies might not be suitable for the patient
- •Female patients without childbearing potential are eligible
- •Female patients with childbearing potential are eligible if they use a medically accepted contraceptive method for the duration of the Compassionate Use Program (CUP) participation. The patient must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and inform the treating physician of any potential change in status
- •Patient is considered reliable and capable of adhering to medication intake.
- •Patient is informed of the details of this CUP, is given ample time and opportunity to ask questions and consider his/her participation in this CUP, and the patient or the legally authorized representative (LAR) has provided verbal consent to participate, and, if required under local regulations, has given written informed consent
排除标准
- •Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behavior, or laboratory values which may have an impact on the safety of the patient, as determined by the treating physician
- •Poor compliance with medication intake in the previous BRV study
- •Participation in any clinical study of another investigation drug or device during the CUP
- •Pregnant or lactating woman
研究者
相似试验
已完成
3 期
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam TreatmentEpilepsyNCT00150800UCB PHARMA Inc. (US)668
Available
不适用
Fremanezumab Managed Access Program for Pediatric PatientsMigraineNCT03539393Teva Branded Pharmaceutical Products R&D LLC
No Longer Available
不适用
A Compassionate Access Protocol For Those Patients Who Have Completed A4001029HIVNCT00801515ViiV Healthcare
Available
不适用
A Compassionate Use Program to Provide Access to Sodium ThiosulfateCisplatin-Induced Hearing Loss in Children Who Had Standard-risk HepatoblastomaNCT04132882TRPHARM
已完成
3 期
Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's SyndromeCushing's DiseaseCushing's SyndromeNCT01371565Corcept Therapeutics4