Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome

Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04062981

Enrollment

Registered

2019-08-20

Start date

2019-05-03

Completion date

2022-12-14

Last updated

2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lennox Gastaut Syndrome

Brief summary

Open-label extension study from YKP509C001 to evaluate the safety and tolerability of carisbamate in subjects with Lennox-Gastaut Syndrome (LGS).

Detailed description

Subjects who successfully completed the YKP509C001 study and could benefit from continued exposure to carisbamate. This is an open-label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through the early termination (ET)/end of study (EOS) visit.

Interventions

DRUGCarisbamate

An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Open-Label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through early termination (ET)/end of study (EOS) visit

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects who completed the YKP509C001 study * Investigator believes subject could benefit from continued exposure to study drug * Subjects must continue to meet all of the inclusion criteria from the YKP509C001 study

Exclusion criteria

* Subjects must continue to not meet any of the

Design outcomes

Primary

Measure	Time frame	Description
Concomitant medication	Up to 20 months	Safety
12-lead electrocardiograms (ECGs)	Up to 20 months	Safety
Physical examinations	Up to 20 months	Safety
Seizure Frequency	Up to 20 months	An assessment of seizure frequency will be made using a subject/caregiver seizure diary with seizure type and number of daily seizures recorded since the prior visit.

Secondary

Measure	Time frame	Description
Safety- adverse events	The duration of this OL study will be until carisbamate bas been approved for treatment of LGS and is available by prescription, or development of carisbamate for LGS has stopped, whichever is first. This could occur up to 36 months.	Adverse events assessment for seriousness (yes, no) severity (mild, moderate, severe), affect on carisbamate dosing (increase,reduced, interrupted, withdrawn, no change) and outcome (recovered/resolved, recovered/resolved with sequelae, recovering/resolving, not recovered/not resolved, fatal or unknown

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026