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Electrophoretic Delivery of γ-aminobutyric Acid GABA into Epileptic Focus Prevents Seizures in Mice
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Antiepileptogenesis and disease modification: Clinical and regulatory issues

Jacqueline A French1, Martina Bebin2, Marc A Dichter3

  • 1NYU Grossman School of Medicine and NYU Langone Health, New York, NY, USA.

Epilepsia Open
|July 16, 2021
PubMed

Insights

This workshop focused on accelerating therapies for antiepileptogenesis (AEG) and epilepsy disease modification. Key discussions included trial design, biomarkers, and regulatory challenges for developing new epilepsy treatments.

Area of Science:

  • Neurology
  • Clinical Trials
  • Epilepsy Research

Background:

  • Epilepsy treatment urgently needs therapies for antiepileptogenesis (AEG) and disease modification.
  • A 2018 NINDS workshop convened experts to address challenges in developing these therapies.

Purpose of the Study:

  • To optimize and accelerate the development of AEG and disease-modifying therapies for epilepsy.
  • To discuss nomenclature, trial design, biomarkers, and regulatory pathways for these novel treatments.

Main Methods:

  • Summary report of discussions from the 2018 NINDS workshop.
  • Review of clinical and regulatory issues in epilepsy therapy development.
  • Case examples including traumatic brain injury and tuberous sclerosis.

Main Results:

  • Nomenclature was clarified into "antiepileptogenic therapies" and "disease modifying therapies."
  • Complexities in trial design for AEG therapies were highlighted, including timing, dosing, and biomarkers.
  • Examples of vigabatrin trials (Epistop, PreVeNT) and a proposed adult trial design were discussed.

Conclusions:

  • Accelerating AEG and disease-modifying therapies requires addressing nomenclature, trial design, and regulatory hurdles.
  • Biomarkers and well-designed clinical trials are crucial for advancing epilepsy treatment.
  • Collaborative efforts are needed to overcome challenges in developing novel epilepsy interventions.
Keywords:
antiepileptogenesisclinical trialsdisease modification

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