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Bridging the Gap: Clinical Trial Design and Implication for Translating Research into Clinical Practice in Epilepsy

Bridging the Gap: Clinical Trial Design and Implication for Translating Research into Clinical Practice in Epilepsy


Slide Lecture Series

Time to Complete

1 hour


June 18, 2015


June 18, 2016
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Maximum Credits

1.00 / AMA PRA Category 1 Credit(s)TM

Accredited Provider

This educational activity is provided by the American Epilepsy Society. This activity was planned in collaboration with AKH Inc.

Commercial Supporter

This activity is supported by an educational grant from UCB, Inc.

Program Description

Epilepsy affects some 2.3 million adults and 467,711 children in the United States. Selecting the best drug for a particular patient and for a specific seizure type can be challenging for clinicians. Evidence based recommendations on the efficacy, tolerability, and safety of several AEDs were developed in 2004. Since this publication, new agents and data have emerged. Concurrently, optimal treatment designs for trials have been brought into question and new study designs developed. The regulatory requirements for the EU and the US vary substantially and their trial outcomes do not directly correlate to clinical application. There is an urgent need for education on the safe and appropriate interpretation and application of trial data to clinical practice.

Intended Audience

Epileptologists, Neurologists, Primary Care Providers, Emergency Room Physicians.

Educational Objectives

Upon completion of this educational activity, participants should be able to:

  • Compare the scientific, clinical and regulatory rationale guiding different trial designs for various indications within epilepsy
  • Identify the current limitations and innovations in clinical trial design for epilepsy
  • Evaluate strategies for applying emerging data from clinical trials in epilepsy to clinical practice.

Conflict Of Interest Disclosure Policy

It is the policy of the AES to make disclosures of financial relationships of faculty, planners and staff involved in the development of educational content transparent to learners. All faculty participating in continuing medical education activities are expected to disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. AES carefully reviews reported conflicts of interest (COI) and resolves those conflicts by having an independent reviewer from the Council on Education validate the content of all presentations for fair balance, scientific objectivity, and the absence of commercial bias. The American Epilepsy Society adheres to the ACCME’s Essential Areas and Elements regarding industry support of continuing medical education; disclosure by faculty of commercial relationships, if any, and discussions of unlabeled or unapproved uses will be made.


Jacqueline A. French, MD
NYU Comprehensive Epilepsy Center

Dr. French is the principle investigator on research performed at NYU for Acorda, Alexza, LCGH, Eisai Medical Research, Lundbeck, Pfizer, SK life sciences, UCB, Upsher-Smith, Vertex.

Staff, Planners, and Reviewers Disclosures

Kevin Graber, MD

Dr. Graber has indicated that he has nothing to disclose.

Planning Committee:
Margaret V. Clark, MS, RN, RRT – NPS
Ms. Clark has indicated that she has nothing to disclose.

R. Michelle Tyner, MS
Ms. Tyner has indicated that she has nothing to disclose.

Paul Levisohn, MD
Dr. Levisohn has indicated that he has nothing to disclose.




AMA PRA Category 1 Credit(s)TM

Accreditation Statement

The American Epilepsy Society is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to offer continuing medical education for physicians.

Designation Statement

The American Epilepsy Society designates this enduring activity for a maximum of 1.00 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosure of Unlabeled Use

Opinions expressed with regard to unapproved uses of products are solely those of the faculty and are not endorsed by the American Epilepsy Society or any manufacturers of pharmaceuticals.


To obtain credit, a score of 70% or better on the post-test is required. This activity is offered at no cost to participants. Please proceed with the activity until you have successfully completed this program, answered all test questions, completed the post-test and evaluation, and have received a digital copy of your credit certificate. Your online certificate will be saved on myCME within your Profile/Exam History, which you can access at any time.
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