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Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

StatusRecruiting
PhasePhase 3
Started2022-04-28
View on ClinicalTrials.gov ↗
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).

Amendment record

Amended 25 times since 2022-01-20; most recent filed 2025-07-21. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2025-07-21
Amendment Study Status, Contacts/Locations v25
2025-03-20
Amendment Study Status, Oversight, Contacts/Locations v24
2024-05-03
Amendment Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v23
2023-11-21
Amendment Study Status v22
2023-09-11
Amendment Study Status, Contacts/Locations v21
2023-09-01
Amendment Study Status, Contacts/Locations v20
2023-08-03
Amendment Study Status, Contacts/Locations v19
2023-08-03
Amendment Study Status, Contacts/Locations v18
2023-06-01
Amendment Study Status, Contacts/Locations v17
2023-05-30
Amendment Study Status, Contacts/Locations v16
2023-05-24
Amendment Study Status v15
2023-04-27
Amendment Study Status, Contacts/Locations v14
2023-04-21
Amendment Study Status, Contacts/Locations v13
2023-04-13
Amendment Study Status, Contacts/Locations v12
2023-04-10
Amendment Study Status, Contacts/Locations v11
2023-04-04
Amendment Study Status, Contacts/Locations v10
2023-03-03
Amendment Study Status, Contacts/Locations v9
2023-02-22
Amendment Study Status, Contacts/Locations v8
2023-02-01
Amendment Study Status, Contacts/Locations v7
2023-01-12
Amendment Study Status, Contacts/Locations v6
2022-12-16
Amendment Study Identification, Study Status, Outcome Measures, Contacts/Locations v5
2022-08-26
Amendment Study Status, Contacts/Locations v4
2022-07-20
Amendment Study Status, Contacts/Locations v3
2022-05-20
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
2022-03-29
Amendment Study Status, Contacts/Locations v1
2022-01-20
Original filing
Trial Details
NCT Number NCT05219617
Lead Sponsor SK Life Science, Inc.
Conditions Seizures, Lennox Gastaut Syndrome
Enrollment 252 participants
Start Date 2022-04-28
Primary Completion 2027-02 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2025-07-24