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Felbamate monotherapy for partial-onset seizures: an active-control trial

E Faught¹, R C Sachdeo, M P Remler

¹Department of Neurology, University of Alabama School of Medicine, Birmingham.

|April 1, 1993

Summary

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Felbamate (FBM) monotherapy effectively treated uncontrolled partial-onset seizures compared to valproate (VPA). FBM demonstrated a favorable safety profile with fewer adverse events during monotherapy.

Area of Science:

Neurology
Clinical Pharmacology

Background:

Epilepsy management often involves complex treatment regimens.
Partial-onset seizures require effective monotherapy options.

Purpose of the Study:

To evaluate the efficacy and safety of felbamate (FBM) monotherapy versus valproate (VPA) in patients with uncontrolled partial-onset seizures.

Main Methods:

A multicenter, double-blind, parallel-group trial involving 111 patients.
Patients received either FBM 3,600 mg/d or VPA 15 mg/kg/d, with baseline antiepileptic drug (AED) tapering.
Efficacy assessed by escape criteria including seizure frequency increase and generalized tonic-clonic seizures (GTCs).

Main Results:

Significantly fewer patients on FBM (18) met escape criteria compared to VPA (37) (p < 0.001).

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Even accounting for dropouts, FBM showed a statistically significant treatment advantage (p = 0.039).

FBM monotherapy was associated with mild to moderate adverse experiences, occurring less frequently than with VPA.

Conclusions:

Felbamate monotherapy is an effective treatment for partial-onset seizures, including those with secondary generalization.
FBM exhibits a favorable safety profile when used as monotherapy for epilepsy management.