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

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