Interim analysis of the long‐term efficacy and safety of azetukalner in an ongoing open‐label extension study following a phase 2b clinical trial (X‐<scp>TOLE</scp>) in adults with focal epilepsy
This long-term study assessed the safety and efficacy of azetukalner to treat focal seizures. Patients taking azetukalner daily with food for about 2 years had far fewer focal seizures with azetukalner than before taking the medication. For those who had been treated for 24 months, about a third were seizure-free for a consecutive 6-month period, and about a quarter were seizure-free for a consecutive 12-month period. Most side effects were mild or moderate, and these included dizziness, headache, and somnolence (sleepiness).
Authors
- Michael A. Rogawski (ORCID: https://orcid.org/0000-0002-3296-8193)
- Jenny Qian
- Martin J. Brodie (ORCID: https://orcid.org/0000-0003-1781-2892)
- Jacqueline A. French (ORCID: https://orcid.org/0000-0003-2242-8027)
- Emilio Perucca (ORCID: https://orcid.org/0000-0001-8703-223X)
- Gregory N. Beatch
- Cynthia L. Harden
- Christopher Kenney
- Constanza Luzon Rosenblut
- Roger J. Porter (ORCID: https://orcid.org/0009-0005-2240-932X)
Institutions
- The University of Melbourne (AU)
- Western Infirmary (GB)
- Xenon Pharmaceuticals (Canada) (CA)
- Austin Health (AU)
- Monash University (AU)
- New York University (US)
- University of Pennsylvania (US)
- University of California, Davis (US)
Publication Details
- Journal
- Epilepsia Open
- Published
- 2025-03-07
- DOI
- https://doi.org/10.1002/epi4.70015
- Citations
- 6
- Primary Topic
- Epilepsy research and treatment
- Type
- article
- Field-Weighted Citation Impact
- 8.83
Funders
- Syracuse University
- State University of New York
- Thomas Jefferson University
- University of South Alabama
- Harmony Biosciences
- SK Life Science
- NeuroPace
- Eisai
- Sun Pharma
- State University of New York Upstate Medical University
- National Institute of Neurological Disorders and Stroke
- UCB Pharma