Help us determine the optimal timing of an experimental treatment for SOD1 ALS, and whether it can delay clinical onset
Recruiting participants
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
Links
Contact
Join our family - together, we can change the course of this disease.
Join our family
Together, we can change the course of this disease.
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