Fairmont Turnberry Isle Resort
April 30, 2011
Purpose: Identify the key problems facing epilepsy clinical trials and propose new approaches (why do trials fail and what can we do to fix them?)
Methodology: Working groups formed in advance of the meeting will prepare a proposal to be presented to the larger group for discussion.
8:00 - 8:15 Welcome (Fureman and French)
Morning sessions: Issues with Trial Methodology
8:15-8:45 Overview: Current status (French)
Session I: Inclusion/exclusion criteria
Working Group: Bergey, Perucca, Hesdorffer, (MaryAnn) Brodie, Versavel, Kossoff, Hirtz
Are currently used inclusion/exclusion criteria appropriate and effective? Will harmonization make trial results more comparable?
9:00-10:00: Open Discussion
Deliverable: Inclusion/Exclusion criteria
10:00-10:15: Coffee Break
Session II: Epilepsy/Seizure confirmation
What should be done to ensure appropriate adult and pediatric patients are enrolled? How should investigators be trained?
Working group: Friedman, Schachter, Glauser, Kwan, Kramer, LaFrance
10:30-11:30: Open Discussion
Deliverable: Plan for screening of potential patients to ensure proper patients are enrolled
Session III: Seizure Diaries
Working Group: Fisher, Herman, Vogelsong, Vannest
What are the problems with existing diaries? What are new/alternative options? How should new methods be validated? How should investigators be trained on seizure classification and diary evaluation?
11:45-12:30: Open Discussion
Deliverables: Recommendation on seizure diaries, Plan for investigator training.
12:30-1:30: Working Lunch (Salon II)
Afternoon sessions: Issues with Trial Design
1:00-1:30: Overview of current status (Baulac)
Session IV: Trial designs: Monotherapy
Messenheimer, (Martin) Brodie, Baulac, Blum, Mintzer, Dlugos, Gilbert, Stables
Are current designs in Europe and the US feasible, interpretable, appropriate, acceptable? Is there an alternative design that would be acceptable to both EMA and FDA?
1:45-2:30: Open Discussion
Deliverable: Considerations for monotherapy design for US and Europe
Session V: Trial designs: Add-on trial considerations
Working group: Ryvlin, French, Bagiella, Emir, Arzimanoglou, Elterman
Are current designs supportable, ethical? What are the alternatives? Should we consider time to event, adaptive designs, other solutions?
2:45-3:30: Open Discussion
Deliverables: Novel Trial Design for adjunctive epilepsy trials
3:30: Wrap-up (Fureman and French)
4:15: Meeting concludes
Last Modified February 6, 2013