2018 Research Roundtable for Epilepsy

Epilepsy News From: Thursday, May 31, 2018
Evolving Concepts in Endpoints and Populations in Epilepsy Trials
The 2018 Research Roundtable for Epilepsy (RRE), held May 17-18, 2018, centered on the topic, “Evolving Concepts in Endpoints and Populations in Epilepsy Trials.” Twenty-five industry organizations, regulators (such as from the U.S. Food and Drug Administration and European Medicines Agency), and community organization representatives gathered for an in-depth discussion. The RRE was led by the following members of the organizing committee:
- Dr. Kathleen Farrell, Director of Clinical Research, Epilepsy Foundation
- Dr. Brandy Fureman, Vice President of Research and New Therapies, Epilepsy Foundation
- Dr. Billy Dunn, Director, Division of Neurology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
- Dr. Jacqueline French, Chief Scientific Officer, Epilepsy Foundation and RRE Co-Chair
- Dr. Nathan Fountain, professor of neurology and director of the F.E. Dreifuss Comprehensive Epilepsy Program at the University of Virginia and RRE Co-Chair
The RRE was guided by a panel of excellent speakers with expertise from:
- Clinical care
- Experiences as a person living with epilepsy
- Research backgrounds
Meeting Goals
The goals of the meeting included:
- Review of the current landscape of pediatric epilepsy clinical trials
- Consider the reasoning for grouping vs. splitting populations by seizure type or by syndrome
- Discuss the full spectrum of disease and how to assess epileptic conditions that comprise more than just seizures
- Learn which co-occuring conditions are a priority to study from the perspective of both people with epilepsy and caregivers
- Learn from the experiences of drug and device companies who have incorporated multiple outcomes into their epilepsy trials
- Identify potential methodologies and statistical considerations for incorporating non-seizure domains into epilepsy studies going forward
Caregivers and leaders representing the Dravet Syndrome Foundation, the Lennox-Gastaut Syndrome Foundation, and the Tuberous Sclerosis Alliance highlighted the unmet need to look at:
- Epilepsy-related conditions as a whole
- Quality of life of the person living with epilepsy and the whole family
- Developing therapies with the guidance of people with epilepsy and caregivers
What's Next?
- Publication of the 2018 RRE meeting discussion is pending, with a goal of early 2019, in Neurology.
- If interested in learning more, please contact Dr. Kathleen Farrell at kfarrell@efa.org.
Authored by
Kathleen Farrell
Reviewed Date
Thursday, May 31, 2018