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

Biogen0 sites1 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•\- 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

•\- 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.

Not specified