TY - JOUR
T1 - Critical appraisal of the recent US FDA approval for earlier DBS intervention
AU - Cabrera, Laura Y.
AU - Goudreau, John
AU - Sidiropoulos, Christos
N1 - Funding Information:
L. Cabrera reports no disclosures relevant to the manuscript. J. Goudreau serves on the Speakers Bureau for Teva Neuroscience and Acadia Pharmaceutical. He has clinical research contracts with Intec Pharmaceutical, Sunovion, Lundbeck Pharmaceutical, Biotie Pharmaceutical, and Adamas Pharmaceutical. He has research grants from the Michael J. Fox Foundation and NINDS (NS099416, NS095656-01, NS065338, NS090259, NS080818-01A). He served as a consultant in the trial of Crowell v Webb. His clinical practice involves evaluation and management of patients with deep brain stimulation (20% effort) and bills for these services. C. Sidiropoulos reports no disclosures relevant to the manuscript. Go to Neurology.org/N for full disclosures.
Publisher Copyright:
© 2018 American Academy of Neurology
PY - 2018
Y1 - 2018
N2 - In November 2015, Medtronic announced the US Food and Drug Administration (FDA) approval for the use of deep brain stimulation (DBS) therapy in people with Parkinson disease (PD) “of at least 4 years duration and with recent onset motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication.” The approval was based on data from the EARLYSTIM clinical trial, a randomized, prospective, multicenter, parallel-group clinical trial in Germany and France involving 251 patients with PD. While others have reviewed the application of DBS earlier in the disease course and the results from EARLYSTIM, we focus on the conceptual, scientific, clinical, ethical, and policy issues that arise regarding the recent FDA approval.
AB - In November 2015, Medtronic announced the US Food and Drug Administration (FDA) approval for the use of deep brain stimulation (DBS) therapy in people with Parkinson disease (PD) “of at least 4 years duration and with recent onset motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication.” The approval was based on data from the EARLYSTIM clinical trial, a randomized, prospective, multicenter, parallel-group clinical trial in Germany and France involving 251 patients with PD. While others have reviewed the application of DBS earlier in the disease course and the results from EARLYSTIM, we focus on the conceptual, scientific, clinical, ethical, and policy issues that arise regarding the recent FDA approval.
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U2 - 10.1212/WNL.0000000000005829
DO - 10.1212/WNL.0000000000005829
M3 - Review article
C2 - 29898975
AN - SCOPUS:85050493696
SN - 0028-3878
VL - 91
SP - 133
EP - 136
JO - Neurology
JF - Neurology
IS - 3
ER -