NL-OMON49747已完成不适用
An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults with C9ORF72-Associated Amyotrophic Lateral Sclerosis - 245AS102
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 1
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
- •- Participants must have completed study 245AS101 through the first follow-up
- •clinic visit that follows the final dosing visit without missing more than 1
- •dose of study treatment.
- •- Participants taking concomitant riluzole at study entry must be on a stable
- •dose for >=30 days prior to the first dose of study treatment (Day 1).
- •Participants taking concomitant riluzole must be willing to continue with the
- •same dose regimen throughout the study, unless the Investigator determines that
- •riluzole should be mdiscontinued for medical reasons, in which case it may not
- •be restarted during the study.
- •- Participants taking concomitant edaravone at study entry must be on a stable
- •dose for >=60 days prior to the first dose of study treatment (Day 1).
- •Participants taking concomitant edaravone must be willing to continue with the
- •same dose regimen throughout the study, unless the Investigator determines that
- •edaravone should be discontinued for medical reasons, in which case it may not
- •be restarted during the study. Edaravone may not be administered on dosing days
- •of this study.
- •Note: Other protocol-specific inclusion criteria may apply.
排除标准
- •- History of drug abuse or alcoholism <=6 months before study enrollment that
- •would limit participation in the study, as determined by the Investigator.
- •- Presence of an implanted shunt for the drainage of CSF or an implanted
- •central nervous system (CNS) catheter.
- •- History of or positive test result at Screening for human immunodeficiency
- •virus. The requirement for testing at Screening may be omitted if it is not
- •permitted by local regulations.
- •- Treatment with another investigational drug (including investigational drugs
- •for ALS through compassionate use programs) or biological agent within 1 month
- •of Screening or 5 half-lives of study agent, whichever is longer.
- •Note: Other protocol-specific exclusion criteria may apply.
研究者
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