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FDA accepts historical controls for epilepsy monotherapy studies
Date:7/20/2010

there is no way to exit a patient at a warning stage, before harm can occur. In a hypertensive patient, one can withdraw a patient on placebo if blood pressure increases, before it gets dangerously high. But with an epilepsy patient, the escape criteria consist of an increase or worsening of seizures, which by itself can be considered an adverse outcome."

The study authors proposed that a historical control, based on an evaluation of prior pseudo-placebo withdrawal to monotherapy studies, would provide a valid alternative to an actual control group. The team analyzed 8 separate studies of similar design and escape criteria, with randomized patients of common demographic characteristics. The primary endpoint was the same for all trials: percent of patients exiting the trial due to seizure worsening. All 8 studies had consistent outcomes, with the percentages of patients exiting their respective trials ranging from 74.9%-95.9%.

Dr. French concludes, "These trials would appear to meet the criteria set forth by ICH for use of historical control. Therefore, this group of trials might reasonably be used as historical controls for future trials of withdrawal to monotherapy using a similar design in a similar population."

The historical control design allows all patients to receive a promising AED at an effective dose, making the study more attractive to patients and to physicians. Dr. Emilio Perucca agreed with these findings, stating in this month's Epilepsia Commentary, "The New York University team should be commended for their scholarly workin setting the stage for a new conversion-to-monotherapy design in which patients are no longer required to receive suboptimal, and therefore, potentially hazardous, treatments."

Based upon this French et al. study, the FDA has accepted the concept of historical controls in this setting, a major milestone in AED development. Several trials utilizing this design planned for regulatory submi
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Contact: Dawn Peters
healthnews@wiley.com
781-388-8408
Wiley-Blackwell
Source:Eurekalert

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