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NCT05219617
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Carisbamate (YKP509) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults, With Optional Open-Label Extension
Phase 3 trial testing Carisbamate in Seizures in 252 participants. Currently enrolling.
1 February 2027
Quick facts
| Lead sponsor | SK Life Science, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 252 |
| Start date | 28 April 2022 |
| Primary completion | 1 February 2027 |
| Estimated completion | 1 December 2028 |
| Sites | 71 locations across United States, Argentina, Australia, Colombia, Germany, Greece, Hungary, Israel |
Drugs / interventions tested
- Carisbamate — full drug profile →
Conditions studied
- Seizures — all drugs for Seizures →
- Lennox Gastaut Syndrome — all drugs for Lennox Gastaut Syndrome →
Sponsor
SK Life Science, Inc. — full company profile →
Who can join
Adults 4 to 55, any sex, with Seizures or Lennox Gastaut Syndrome. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Primary outcome will be the percentage change from baseline in the total frequency (average per 28 days) of countable drop seizures with potential to fall (tonic, atonic, tonic-clonic) seizures during the double-blind treatment period.
Time frame: 3 years
Efficacy of Carisbamate YKP509
Sponsor's own description
The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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The burden of illness in Lennox-Gastaut syndrome: a systematic literature review.
Strzelczyk A, Zuberi SM, Striano P, Rosenow F, et al · · 2023 · cited 40× · PMID 36859290 · DOI 10.1186/s13023-023-02626-4 -
Refining management strategies for Lennox-Gastaut syndrome: Updated algorithms and practical approaches.
Auvin S, Arzimanoglou A, Falip M, Striano P, et al · · 2025 · cited 24× · PMID 39700524 · DOI 10.1002/epi4.13075 -
Clinical trials for Lennox-Gastaut syndrome: Challenges and priorities.
Knowles JK, Warren AEL, Mohamed IS, Stafstrom CE, et al · · 2024 · cited 17× · PMID 39440617 · DOI 10.1002/acn3.52211 -
Epilepsy therapy beyond neurons: Unveiling astrocytes as cellular targets.
Chen Y, Hu J, Zhang Y, Peng L, et al · · 2026 · cited 9× · PMID 39819836 · DOI 10.4103/nrr.nrr-d-24-01035 -
Recent Advances in the Management of Seizures in Children.
Besag FMC, Vasey MJ, Chin RFM. · · 2026 · cited 1× · PMID 41045442 · DOI 10.1007/s40272-025-00710-9
Verify or expand the search:
- PubMed search for NCT05219617
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Carisbamate
Trials testing the same drug.
- NCT04520360 — Bioavailability and Food Effect Study of 3 Types of Carisbamate · Phase 1 · completed
- NCT04062981 — Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome · Phase 1 · completed
- NCT03731715 — Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome · Phase 1 · completed
Other recruiting trials for Seizures
Currently open trials in the same condition.
- NCT07072624 — Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial) · Phase 4 · recruiting
- NCT06714448 — A Study of the Effectiveness of Risk Minimization Measures Related to Depakine® (Sodium Valproate) in Saudi Arabia · active not recruiting
- NCT07136298 — Seizure Identification on the Intensive Care Unit (ICU) · recruiting
- NCT06442748 — Short Versus Long-term Levetiracetam in Brain Tumors · Phase 3 · recruiting
- NCT06401707 — PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest · Phase 2 · recruiting
Other SK Life Science, Inc. trials
Trials by the same sponsor.
- NCT06453213 — Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy · Phase 4 · active not recruiting
- NCT05572255 — A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Admini · Phase 1 · completed
- NCT05388435 — Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients · Phase 1, PHASE2 · terminated
- NCT04791553 — Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment · Phase 1 · completed
- NCT04903314 — Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05219617 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SK Life Science, Inc.
- Last refreshed: 21 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05219617.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing