Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
139 participants
INTERVENTIONAL
2017-03-08
2024-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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BIIB067
Participants who have completed Parts A, B, or C of study 233AS101 will be placed in this arm.
Tofersen
Participants will receive a loading dose regimen followed by maintenance dosing.
Interventions
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Tofersen
Participants will receive a loading dose regimen followed by maintenance dosing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If taking riluzole, participant must be receiving a stable dose for ≥30 days prior to Day 1.
* 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 during this study.
* 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.
* For female participants of childbearing potential must agree to practice effective contraception during the study and be willing and able to continue contraception for 5 months after their last dose of study treatment.
* 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.
Exclusion Criteria
* 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 a Lumbar Puncture (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 central nervous system (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.
* 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.
* Female participants who are pregnant or currently breastfeeding.
* Current enrollment in any other interventional study.
18 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
La Jolla, California, United States
Research Site
San Francisco, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Baltimore, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Rochester, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Cleveland, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Leuven, , Belgium
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Bispebjerg Hospital
Copenhagen, , Denmark
Research Site
Clermont-Ferrand, Puy De Dome, France
Research Site
Ulm, Baden-Wurttemberg, Germany
Research Site
Torino, , Italy
Research Site
Bunkyō City, , Japan
Research Site
Kagoshima, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Suita-shi, , Japan
Research Site
Sheffield, South Yorkshire, United Kingdom
Countries
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References
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Miller TM, Cudkowicz ME, Genge A, Shaw PJ, Sobue G, Bucelli RC, Chio A, Van Damme P, Ludolph AC, Glass JD, Andrews JA, Babu S, Benatar M, McDermott CJ, Cochrane T, Chary S, Chew S, Zhu H, Wu F, Nestorov I, Graham D, Sun P, McNeill M, Fanning L, Ferguson TA, Fradette S; VALOR and OLE Working Group. Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. N Engl J Med. 2022 Sep 22;387(12):1099-1110. doi: 10.1056/NEJMoa2204705.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003225-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
233AS102
Identifier Type: -
Identifier Source: org_study_id
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