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Felbamate: a clinical trial for complex partial seizures
W H Theodore1, R F Raubertas, R J Porter
1Clinical Epilepsy Section Medical Neurology Branch, NINDS, National Institutes of Health, Bethesda, Maryland 20892.
Epilepsia
|May 1, 1991
Summary
Felbamate (FBM) was well tolerated in patients with complex partial seizures. Although FBM lowered carbamazepine (CBZ) levels, it showed a strong antiseizure effect when adjusted for this interaction.
Area of Science:
- Neurology
- Clinical Pharmacology
Background:
- Complex partial seizures (CPS) represent a significant challenge in epilepsy management.
- Carbamazepine (CBZ) is a common antiepileptic drug, but its efficacy and tolerability can vary.
- Investigating adjunctive therapies is crucial for improving seizure control in patients with CPS.
Purpose of the Study:
- To evaluate the efficacy and tolerability of felbamate (FBM) as an adjunctive therapy in patients with CPS.
- To assess the effect of FBM on carbamazepine (CBZ) levels in patients with CPS.
Main Methods:
- A randomized, double-blind, three-period cross-over study design was employed.
- Thirty patients with CPS on stable CBZ therapy were enrolled.
- Patients received FBM or placebo in addition to their ongoing CBZ treatment.
Main Results:
- Felbamate (FBM) was well tolerated by 28 of 30 patients, with only mild adverse experiences reported.
- FBM significantly reduced carbamazepine (CBZ) plasma levels by 20-28% (p < 0.0001).
- While raw seizure frequency did not differ significantly between FBM and placebo periods, a strong antiseizure effect of FBM was suggested after adjusting for reduced CBZ levels.
Conclusions:
- Felbamate (FBM) demonstrates good tolerability in patients with complex partial seizures (CPS) when used adjunctively.
- The interaction between FBM and carbamazepine (CBZ), leading to decreased CBZ levels, requires careful consideration.
- Adjusted analysis indicates a potential significant antiseizure efficacy of FBM in CPS management.