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Antiepileptogenesis and disease modification: Clinical and regulatory issues.

Publication ,  Journal Article
French, JA; Bebin, M; Dichter, MA; Engel, J; Hartman, AL; Jóźwiak, S; Klein, P; McNamara, J; Twyman, R; Vespa, P
Published in: Epilepsia Open
September 2021

This is a summary report of clinical and regulatory issues discussed at the 2018 NINDS workshop, entitled "Accelerating Therapies for Antiepileptogenesis and Disease Modification." The intent of the workshop was to optimize and accelerate development of therapies for antiepileptogenesis (AEG) and disease modification in the epilepsies. The working group discussed nomenclature for antiepileptogenic therapies, subdividing them into "antiepileptogenic therapies" and "disease modifying therapies," both of which are urgently needed. We use the example of traumatic brain injury to explain issues and complexities in designing a trial for disease-preventing antiepileptogenic therapies, including identifying timing of intervention, selecting the appropriate dose, and the need for biomarkers. We discuss the recent trials of vigabatrin to prevent onset and modify epilepsy outcome in children with tuberous sclerosis (Epistop and PreVeNT). We describe a potential approach to a disease modification trial in adults, using patients with temporal lobe epilepsy. Finally, we discuss regulatory hurdles for antiepileptogenesis and disease-modifying trials.

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Published In

Epilepsia Open

DOI

EISSN

2470-9239

Publication Date

September 2021

Volume

6

Issue

3

Start / End Page

483 / 492

Location

United States

Related Subject Headings

  • Vigabatrin
  • United States
  • National Institute of Neurological Disorders and Stroke (U.S.)
  • Humans
  • Epilepsy
  • Child
  • Brain Injuries, Traumatic
  • Anticonvulsants
  • Adult
  • 5202 Biological psychology
 

Citation

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French, J. A., Bebin, M., Dichter, M. A., Engel, J., Hartman, A. L., Jóźwiak, S., … Vespa, P. (2021). Antiepileptogenesis and disease modification: Clinical and regulatory issues. Epilepsia Open, 6(3), 483–492. https://doi.org/10.1002/epi4.12526
French, Jacqueline A., Martina Bebin, Marc A. Dichter, Jerome Engel, Adam L. Hartman, Sergiusz Jóźwiak, Pavel Klein, James McNamara, Roy Twyman, and Paul Vespa. “Antiepileptogenesis and disease modification: Clinical and regulatory issues.Epilepsia Open 6, no. 3 (September 2021): 483–92. https://doi.org/10.1002/epi4.12526.
French JA, Bebin M, Dichter MA, Engel J, Hartman AL, Jóźwiak S, et al. Antiepileptogenesis and disease modification: Clinical and regulatory issues. Epilepsia Open. 2021 Sep;6(3):483–92.
French, Jacqueline A., et al. “Antiepileptogenesis and disease modification: Clinical and regulatory issues.Epilepsia Open, vol. 6, no. 3, Sept. 2021, pp. 483–92. Pubmed, doi:10.1002/epi4.12526.
French JA, Bebin M, Dichter MA, Engel J, Hartman AL, Jóźwiak S, Klein P, McNamara J, Twyman R, Vespa P. Antiepileptogenesis and disease modification: Clinical and regulatory issues. Epilepsia Open. 2021 Sep;6(3):483–492.
Journal cover image

Published In

Epilepsia Open

DOI

EISSN

2470-9239

Publication Date

September 2021

Volume

6

Issue

3

Start / End Page

483 / 492

Location

United States

Related Subject Headings

  • Vigabatrin
  • United States
  • National Institute of Neurological Disorders and Stroke (U.S.)
  • Humans
  • Epilepsy
  • Child
  • Brain Injuries, Traumatic
  • Anticonvulsants
  • Adult
  • 5202 Biological psychology