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. Author manuscript; available in PMC: 2013 Mar 6.
Published in final edited form as: Lancet Neurol. 2008 Aug;7(8):742–755. doi: 10.1016/S1474-4422(08)70165-0

Table 1.

Summary of published randomized, double blind, controlled trials of felbamate in patients with epilepsy.

Study Participants Treatment Primary Outcomes Main Results
Partial Seizures (adjunctive therapy) Theodore et al, 1991 N=47
≥6 seizures during 3-week baseline period on CBZ		 FBM 2400–3000 mg/d or PLC plus CBZ # of seizures

  • No significant difference in seizure frequency between FBM and PLC treatment periods (P=0.172)
Leppik et al, 1991 N=67
≥4 seizures/month on CBZ and PHT		 FBM 2300 mg/d (mean) or PLC plus CBZ and PHT SFR; SFPR†; TSFPR#

  • On average, patients had 34.4 seizures with FBM vs 40.2 seizures with PLC per 8-wk treatment period

  • FBM was better than PLC for SFR, SFPR, and TSFPR (P<0.5)
Partial Seizures (monotherapy) Sachdeo et al, 1992 N=44
≥8 seizures during 56-day baseline period on 1–2 AEDs		 FBM 3600 mg/d (mean) or VPA 1225 mg/d (mean) # of patients who met escape criteria‡

  • 14% of FBM patients vs 86% of PLC patients met escape criteria (P<0.001)

  • FBM patients had a 50–65% decrease in seizure frequency compared to baseline period
Faught et al, 1993 N=111
≥8 seizures during 56-day baseline period on 1–2 AEDs		 FBM 3600 mg/d (mean) or VPA 1080 mg/d (mean) # of patients who met escape criteria‡

  • 40% of FBM patients vs 78% of PLC patients met escape criteria (P<0.001)
Lennox-Gastaut Syndrome (adjunctive therapy) FBM Study Group, 1993 N=73
Multiple seizure types; ≥90 atonic or atypical absence seizures/month on 1–2 AEDs		 FBM 3600 mg/d or PLC plus 1–2 other AEDs # of seizures; # of atonic seizures; Caregivers’ global evaluation

  • FBM patients had a 11% decrease in seizure frequency whereas PLC patients had a 1% increase compared to baseline period (P=0.32)

  • FBM patients had a 34% decrease in atonic seizure frequency whereas PLC patients had a 9% decrease compared to baseline period (P=0.01)

  • Global evaluation scores were higher for FBM than PLC (P<0.001)

AED=antiepileptic drugs. CBZ=carbamazepine. FBM=felbamate. PHT=phenytoin. PLC=placebo. SFR=seizure frequency reduction. SFPR=seizure frequency percentage reduction. TSFPR=truncated seizure frequency percentage reduction. VPA=valproate.

SFR equals seizure frequency in baseline period minus seizure frequency in treatment period.

†

SFPR equals SFR × 100 divided by seizure frequency in baseline period.

#

TSFPR equals SFPR except that SFPR values less than −100 are truncated to −100.

‡

Criteria to escape relative to baseline were: 1) 2-fold increase in monthly seizure frequency, 2) 2-fold increase in highest 2-day seizure frequency, 3) single generalized tonic-clonic seizure if none occurred during baseline, or 4) significant prolongation of generalized tonic-clonic seizures.