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

Biogen Idec Research Limited0 个研究点目标入组 183 人开始时间: 2020年7月22日最近更新: 2021年5月17日

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•- Must have diagnosis of SOD1-ALS, and must have completed the End of Study Visit for either Parts A, B and/or C of Study 233AS101 (i.e., were not withdrawn).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 233AS102.
•- If taking edaravone, participant must have initiated edaravone = 60 days (2 treatment cycles) prior to Day 1. Edaravone may not be administered on dosing days.
•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

•Key Exclusion Criteria:
•- 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

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