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. 2010 Jan;10(1):1–6. doi: 10.1111/j.1535-7511.2009.01336.x

TABLE 2.

Summary of Clinical Studies with Rufinamide

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.