This is a 6-month randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of natalizumab as adjunctive therapy in the treatment of adult subjects with drug-resistant focal epilepsy. The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency.
- Diagnosed with drug-resistant focal epilepsy.
- Currently on a stable regiment of 1-5 AEDs.
- On average experience 6 or more seizures during a 6 week baseline.
- Diagnosis of generalized, combined generalized and focal, or unknown epilepsy.
- History of status epilepticus within the last 12 months.
- History or presence of non-epileptic seizures.
Number of research visits:15
Length of participation: 60 weeks
Number of blood collections: up to 15
MRI scan within 48 months of enrollment.