TABLE 2.
STUDY TYPE | SEIZURE TYPE | DAILY DOSE | AGE (YEARS) | OUTCOME* | REFERENCE |
---|---|---|---|---|---|
Adjunct | Lennox–Gastaut syndrome | 45 mg/kg (maximum 3,200 mg) or placebo | 4 to 30 | ↓Drop attacks ↓Total seizures ↓Seizure severity | 8 |
Adjunct | Partial onset | 200, 400, 800, 1,600 or placebo | ≥15 | ↓Total seizures (+) Responder rate | 1 |
Adjunct | Partial onset | 3,200 mg or placebo | ≥16 | ↓Total seizures (+) Responder rate | 1 |
Monotherapy | Partial onset | 3,200 mg or placebo | ≥12 | Fewer seizures and longer time to first, second, and third seizure for rufinamide | 1 |
Adjunct† | Primary GTC | 800 mg or placebo | ≥4 | No difference vs. placebo | 7 |
Abbreviations: GTC, generalized tonic–clonic.
All were significant (p < 0.05) except study Ref. 7.
The doses used did not provide patients with plasma rufinamide concentrations that are therapeutic for other seizure types, which could explain the lack of efficacy seen in this study.