Journal article
A multi-dataset time-reversal approach to clinical trial placebo response and the relationship to natural variability in epilepsy
DM Goldenholz, A Strashny, M Cook, R Moss, WH Theodore
Seizure | W B SAUNDERS CO LTD | Published : 2017
Abstract
Purpose Clinical epilepsy drug trials have been measuring increasingly high placebo response rates, up to 40%. This study was designed to examine the relationship between the natural variability in epilepsy, and the placebo response seen in trials. We tested the hypothesis that ‘reversing' trial direction, with the baseline period as the treatment observation phase, would reveal effects of natural variability. Method Clinical trial simulations were run with time running forward and in reverse. Data sources were: SeizureTracker.com (patient reported diaries), a randomized sham-controlled TMS trial, and chronically implanted intracranial EEG electrodes. Outcomes were 50%-responder rates (RR50)..
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Awarded by National Institute of Neurological Disorders and Stroke
Funding Acknowledgements
This study in full was supported by the National Institute of Neurological Disorders and Stroke Division of Intramural Research. This study was approved by the Office of Human Subject Research Protection under protocol #12301. Use of the NeuroVista and SeizureTracker data was facilitated by the International Seizure Diary Consortium (https://sites.google.com/site/isdchome/). The findings and conclusions in this paper are those of the authors and do not necessarily represent the official position of the National Center for Health Statistics or the Centers for Disease Control.