EUCTR2016-003225-41-IT进行中（未招募）1 期
An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation - na
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 182
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Must have diagnosis of SOD1-ALS, and must have completed the End of
- •Study Visit for either Parts A, Band/or C of Study 233AS101 (i.e., were
- •not withdrawn).
- •- If taking riluzole, must be receiving a stable dose for =30 days prior to
- •Day 1 and expected to remain at that dose until the final study visit.
- •- For female participants of childbearing potential must agree to practice
- •effective contraception during the study and for 5 months after their last
- •dose of study treatment.
- •- Medically able to undergo the study procedures, and to adhere to the
- •visit schedule at the time of study entry, as determined by the
- •Investigator.
- •- Participants from Study 233AS101 Parts A and B must have a washout
- •=16 weeks between the last dose of study treatment received in Study
- •233AS101 and the first dose of BIIB067 received in the current Study
- •- If taking edaravone, participant must have initiated edaravone = 60
- •days (2 treatment cycles) prior to Day 1. Edaravone may not be administered on dosing
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 146
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •- History of allergies to a broad range of anaesthetics.
- •- Presence of risk for increased or uncontrolled bleeding and/or risk of
- •bleeding that is not managed optimally and could place a participant at
- •an increased risk for bleeding during or after an LP procedure. These
- •risks could include, but are not limited to, anatomical factors at or near
- •the LP site (e.g., vascular abnormalities, neoplasms, or other
- •abnormalities) and underlying disorders of the coagulation cascade,
- •platelet function, or platelet count (e.g., hemophilia, Von Willebrand's
- •disease, liver disease).
- •- Presence of an implanted shunt for the drainage of CSF or an implanted
- •CNS catheter.
- •- Prior or current treatment with small interfering ribonucleic acid
- •(RNA), stem cell therapy, or gene therapy.
- •- Treatment with another investigational drug, biological agent
- •(excluding BIIB067), or device within 1 month or 5 half-lives of study
- •agent, whichever is longer.
- •- Current or anticipated need, in the opinion of the Investigator, of a
- •diaphragm pacing system (DPS) during the study period.
- •- Female subjects who are pregnant or currently breastfeeding.
- •- Current enrollment in any other interventional study.
- •- Current or recent (within 1 month) use, or anticipated need, in the
- •opinion of the Investigator, of copper (II) (diacetyl-bis (N4-
- •methylthiosemicarbazone)) or pyrimethamine.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究者
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