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Dr. Vicente Villanueva – What does Freedon Study tell us? Real-life outcomes of cenobamate in different lines of treatment

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Dr. Vicente Villanueva – What does Freedon Study tell us? Real-life outcomes of cenobamate in different lines of treatment

Cenobamate is a promising treatment option for adults with uncontrolled focal seizures, demonstrating significant seizure freedom rates in pivotal trials. Its efficacy was established in two studies, C013 and C017—randomized, double-blind, placebo-controlled trials enrolling 659 patients on 1–3 concomitant antiseizure medications (ASMs), with treatment durations of up to 18 weeks1,2. Read more about C017 here.

While real-world evidence (RWE) from mainly highly refractory patient populations has corroborated the clinical trial result 3-6. However, more studies are needed to assess cenobamate’s effectiveness when introduced earlier in the treatment journey.4 Ongoing and recently published7,8  studies are addressing this gap, aiming to expand our understanding of cenobamate's clinical utility and its potential to improve patient outcomes.

Professor Villanueva is principal investigator in a multicenter, retrospective and observational Freedon study. We asked him to summarize most important aspects and findings of the study and give his thoughts on how clinicians can use the information in daily practice.

Freedon study aimed to evaluate the impact of cenobamate when used at different lines of treatment (earlier vs. later in the treatment sequence) and sought to determine whether earlier use of CNB improves outcomes, including the likelihood of achieving seizure freedom. Collecting evidence on how an ASM performs in real-world settings is a way to provide valuable insights into its use and place in epilepsy therapy.

Study Design:

Inclusion Criteria:

Multicenter, retrospective, and observational.

Adults (≥18 years) with focal-onset seizures.

Data sourced from clinical records; analysis at baseline, 6 months, and 12 months.

Failed 2-6 prior antiseizure medications (ASMs) before cenobamate (CNB) initiation.

486 adult patients with focal-onset seizures included.

 

Professor Vicente Villanueva is an expert in epilepsy and serves as Head of Section, Refractory Epilepsy Unit, Neurology Service, Hospital Universitario y Politecnico La Fe, Spain. His current research interests include refractory epilepsy, video-EEG monitoring, epilepsy clinical trials, and epilepsy surgery.

  1. Krauss GL et al. Lancet Neurol 2020; 19(1): 38-48.
  2. Chung SS et al. Neurology 2020;94:1-e12
  3. Pietrafusa N et l. What have we learned from real word evidence? Front Pharmacol. 2023;14:1239152.
  4. Gjerulfsen CE et al. Neur Sci 2025;46(8):3875-3884
  5. Villanueva V et al. Epilepsia Open. 2023;8(3):918-929
  6. Beltrán-Corbellini A et al. Seizure. 2023;111:71-77
  7. Winter Y et al. CNS Drugs 2024;38: 733–742
  8. Lattanzi S et al. Epilepsia 2025;66:2239-2252
  9. Villanueva V et al. Freedon study: Real-life outcomes of cenobamate at different lines of treatment. Poster presented at: 36th International Epilepsy Congress, Lisbon 30.8.-3.9.2025

Ontozry® (cenobamat) 12,5 mg odragerad tablett samt 25 mg, 50 mg, 100 mg, 150 mg och 200 mg filmdragerade tabletter. Rx F. ATC-kod: N03AX25 - antiepileptika, övriga antiepileptika. Indikation: Ontozry är indicerat som tilläggsbehandling av fokala anfall, med eller utan sekundär generalisering hos vuxna patienter med epilepsi, som inte kontrollerats tillräckligt trots tidigare behandling med minst två antiepileptika. Kontraindikationer: Överkänslighet mot den aktiva substansen eller mot något hjälpämne, ärftligt kort QT-syndrom. Varningar: Patienter ska uppsöka läkare om tecken på självmordstankar/självmordsbeteende uppstår, samt om tecken och symptom på läkemedelsreaktion med eosinofili och systemiska symtom (DRESS) inträffar. Innehåller laktos. Cenobamat kan minska exponeringen av substanser som metaboliseras via CYP3A4, CYP2B6 samt öka exponeringen av substanser som metaboliseras via CYP2C19. Cenobamat rekommenderas inte till fertila kvinnor som inte använder preventivmedel eller vid amning. MAH: Angelini Pharma S.p.A. Lokal kontakt: Angelini Pharma Nordics, nordic.medinfo@angelinipharma.com. Datum för senaste översyn av SPC: 11/2023. För AUP och ytterligare information, se www.fass.se. ▼Detta läkemedel är föremål för utökad övervakning.

MAT-DK-0065-P 6.11.2025