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High-dose Nusinersen (DEVOTE) in SMA
NCT04089566Phase 3Completed
- Sponsor
- Biogen
- Start
- Mar 2020
- Primary completion
- Feb 2024
- Modality
- Modified DNA Oligonucleotides, Single-strand DNA, Antisense Oligonucleotides (ASOs)
- Countries
- 18
01
Overview
Phase 3, randomised, double-blind trial of nusinersen in spinal muscular atrophy (SMA) (4 arms), sponsored by Biogen. Primary endpoints: Change From Baseline in CHOP-INTEND Total Score for 50/28mg Nusinersen Versus CS3B Matched Sham Control Group at Day 183, Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) at Day 361 and 1 more. Started Mar 2020; status: completed.
02
Drugs
nusinersen
03
Conditions
spinal muscular atrophy (SMA)
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