Post-hoc analyses of the edaravone clinical trials Study 16 and Study 19: a step toward more efficient clinical trial designs in amyotrophic lateral sclerosis-Reference-Cited by-同舟云学术

Post-hoc analyses of the edaravone clinical trials Study 16 and Study 19: a step toward more efficient clinical trial designs in amyotrophic lateral sclerosis

Published:2019-04-13 Issue:5-6 Volume:20 Page:421-431
ISSN:2167-8421
Container-title:Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
language:en
Short-container-title:Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration

Author:

Palumbo Joseph M.¹²,Hubble Jean³,Apple Stephen³,Takei Koji²,Tsuda Kikumi²,Liu Shawn¹,Zhang Jeffrey⁴,Agnese Wendy³

Affiliation:

1. Mitsubishi Tanabe Pharma Development America, Jersey City, NJ, USA,

2. Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan,

3. Mitsubishi Tanabe Pharma America, Jersey City, NJ, USA, and

4. Princeton Pharmatech, Princeton, NJ, USA

Funder

Mitsubishi Tanabe Pharma America Inc

Publisher

Informa UK Limited

Subject

Neurology (clinical),Neurology

Link

https://www.tandfonline.com/doi/pdf/10.1080/21678421.2019.1599955

Reference18 articles.

1. Shortcomings in the Current Amyotrophic Lateral Sclerosis Trials and Potential Solutions for Improvement

2. Clinical trials in amyotrophic lateral sclerosis: why so many negative trials and how can trials be improved?

3. Center for Drug Evaluation and Research (CDER). Guidance for industry: enrichment strategies for clinical trials to support approval of human drugs and biological products. 2012. Available at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm332181.pdf. Accessed January 7, 2019.

4. Edaravone in Amyotrophic Lateral Sclerosis’Lessons from the Clinical Development Program and the Importance of a Strategic Clinical Trial Design

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