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Editorial
. 2023 Jun;67(6):433-435.
doi: 10.1002/mus.27828. Epub 2023 Apr 10.

Hopes and concerns regarding the implementation of expanded access protocols in amyotrophic lateral sclerosis

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Editorial

Hopes and concerns regarding the implementation of expanded access protocols in amyotrophic lateral sclerosis

Ikjae Lee et al. Muscle Nerve. 2023 Jun.
No abstract available

Keywords: EAP; amyotrophic lateral sclerosis; compassionate use; expanded access; expanded access protocol.

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References

REFERENCES

    1. Bensimon G, Lacomblez L, Meininger V. A controlled trial of riluzole in amyotrophic lateral sclerosis. ALS/Riluzole study group. N Engl J Med. 1994;330(9):585-591.
    1. Writing G, Edaravone ALSSG. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16(7):505-512.
    1. Paganoni S, Macklin EA, Hendrix S, et al. Trial of sodium Phenylbutyrate-Taurursodiol for amyotrophic lateral sclerosis. N Engl J Med. 2020;383(10):919-930.
    1. Yerton M, Winter A, Gelevski D, et al. Expanded access protocol (EAP) program for access to investigational products for amyotrophic lateral sclerosis (ALS). Muscle Nerve. 2023;67(6):456-463. doi:10.1002/mus.27819.
    1. FDA Releases Action Plan for Rare Neurodegenerative Diseases Including ALS, U.S. FOOD & DRUG ADMINSTRATION website, https://www.fda.gov/news-events/press-announcements/fda-releases-action-..., updated June 23, 2022. Accessed March 28, 2023.

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