Failures to Replicate: What Recent Negative Phase 3 Trials Have Taught Us about Amyotrophic Lateral Sclerosis Clinical Research

Author:

Shefner Jeremy M.1ORCID,Cudkowicz Merit E.2ORCID

Affiliation:

1. Barrow Neurological Institute Phoenix AZ USA

2. Massachusetts General Hospital Boston MA USA

Publisher

Wiley

Reference18 articles.

1. A Phase 2, Double-Blind, Randomized, Dose-Ranging Trial Of Reldesemtiv In Patients With ALS

2. Cytokinetics.Cytokinetics Announces COURAGE‐ALS Met Criteria for Futility at Second Interim Analysis [press release]. March 31 2023 2023.

3. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients

4. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial

5. MT Pharma America.Mitsubishi Tanabe Pharma America Announces Update on Global Phase 3b MT‐1186‐A02 Postmarketing Study of Oral Edaravone in ALS [press release]. March 31 2024 2024.

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