Help us determine the optimal timing of an experimental treatment for SOD1 ALS, and whether it can delay clinical onset

Active - Not Recruiting

Study Name
Biogen ATLAS Trial
PI
Biogen (sponsor). Academic Lead: Michael Benatar, MD, PhD.
Study Type
Interventional (double-blind and open-label phases)
Eligible Population
Part A (Natural History Run-In)
  • Age 18+
  • Carrier of a protocol-defined SOD1 mutation
  • Clinically pre-symptomatic for ALS
  • Plasma neurofilament light (NfL) level below protocol-defined threshold at time of screening
Study Purpose/Goals
To evaluate whether pre-symptomatic initiation of tofersen can delay the emergence of clinically manifest ALS and/or slow decline in function after emergence of clinically manifest ALS.

Procedures/Participation
Up to 6.5 years of participation

  • Screening: up to 42 days
  • Part A (Natural History Run-In): up to 6.5 years
  • Treatment: up to 2 years
  • Open label extension

Procedures

  • Medical history and medication review
  • Drug dosing (as applicable)
  • Blood, urine and CSF collection
  • Neurological exam
  • Electrocardiogram
  • Physical exam
  • Surveys
  • Breathing test

Join our family - together, we can change the course of this disease.

Join our family

Together, we can change the course of this disease.