Carisbamate for Lennox-Gastaut syndrome
Fact-checked by What is carisbamate for Lennox-Gastaut syndrome?
Carisbamate is an investigational oral therapy being developed by SK Biopharmaceuticals for the treatment of seizures in people with Lennox-Gastaut syndrome (LGS).
Seizures are caused by excessive, synchronized nerve cell firing. Carisbamate, formulated as an oral liquid, is designed to block certain sodium channels on the surface of nerve cells. By preventing sodium from entering the cells, carisbamate helps control their firing and prevent seizures.
The medication holds orphan drug status in the U.S. for the treatment of LGS — a designation intended to support its clinical development. It is currently being tested in a Phase 3 clinical trial for that indication.
Therapy snapshot
| Treatment name | Carisbamate |
| Administration | Oral liquid |
| Clinical testing | Currently in Phase 3 testing |
How will carisbamate be administered in LGS?
In a Phase 3 clinical trial, carisbamate is being administered as an oral liquid suspension.
After an initial dose titration period, participants ages 12 and older receive a fixed maintenance dose of 200 mg or 300 mg, taken twice daily. In younger patients, the corresponding doses are weight-based.
Carisbamate in Lennox-Gastaut syndrome clinical trials
Carisbamate is being tested against a placebo in the Phase 3 DISCOVER trial (NCT05219617), which includes people with LGS ages 4 to 55. Participants will be assigned to receive either carisbamate or a placebo as an add-on to their existing treatment regimen for a little over three months, after which all will be transitioned to carisbamate. The main goal is to evaluate changes in the frequency of drop seizures, or seizure types that could cause falls.
The medication was previously tested in a Phase 1 safety study (NCT03731715) and its open-label extension (NCT04062981). The treatment was found to be generally safe and well tolerated in adults and children with LGS.
Carisbamate side effects
In a Phase 1 trial, most side effects were nervous system-related and mild or moderate in severity. One severe side effect, a mood disorder, was considered possibly related to carisbamate.
Safety findings from Phase 3 testing are not yet available.
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