Final safety, tolerability, and seizure outcomes in patients with focal epilepsy treated with adjunctive perampanel for up to 4 years in an open-label extension of phase III randomized trials: Study 307

Author:

Krauss Gregory L.1,Perucca Emilio23,Kwan Patrick45,Ben-Menachem Elinor6,Wang Xue-Feng7,Shih Jerry J.8,Patten Anna9,Yang Haichen10,Williams Betsy11,Laurenza Antonio11

Affiliation:

1. Department of Neurology; Johns Hopkins University; Baltimore MD USA

2. IRCCS Mondino Foundation; Pavia Italy

3. Department of Internal Medicine and Therapeutics; University of Pavia; Pavia Italy

4. Royal Melbourne Hospital; University of Melbourne; Parkville Vic. Australia

5. Prince of Wales Hospital; The Chinese University of Hong Kong; Hong Kong China

6. Sahlgrenska Academy; Gothenburg Sweden

7. Chongqing Key Laboratory of Neurology; First Affiliated Hospital of Chongqing Medical University; Chongqing China

8. Department of Neurosciences; UCSD School of Medicine; La Jolla CA USA

9. Department of Biostatistics; Eisai Ltd.; Hatfield UK

10. Former Employee of Eisai Inc.; Woodcliff Lake NJ USA

11. Eisai Neurology Business Group; Eisai Inc.; Woodcliff Lake NJ USA

Funder

Eisai

Publisher

Wiley

Subject

Neurology (clinical),Neurology

Reference15 articles.

1. European Medicines Agency (EMA) Fycompa ® Annex I: Summary of Product Characteristics http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002434/WC500130815.pdf

2. Food and Drug Administration (FDA) Fycompa ® Prescribing Information https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf

3. Randomized phase III study 306: adjunctive perampanel for refractory partial-onset seizures;Krauss;Neurology,2012

4. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304;French;Neurology,2012

5. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: results of randomized global phase III study 305;French;Epilepsia,2013

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