Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
The primary efficacy objective of the study is to determine if adjunctive therapy of
 natalizumab 300 mg 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.
Key Inclusion Criteria:

 -  Must have focal epilepsy diagnosed on clinical grounds and as applicable supported by
 electroencephalogram findings [Scheffer 2017] and brain imaging. Participants with
 multifocal epilepsy may be included if all other entry criteria are met.

 -  Must have a drug-resistant epilepsy defined as failure of adequate trials of 2 (or
 more) tolerated and appropriately chosen and used AEDs (whether as monotherapies or in
 combination) [Kwan 2010].

 -  Experiences 6 or more seizures during the 6-week prospective baseline period and is
 not seizure free for more than 21 consecutive days during the prospective baseline
 period

 Key Exclusion Criteria:

 -  Focal aware seizures without motor signs are the only seizure type.

 -  Diagnosis of generalized, combined generalized and focal, or unknown epilepsy

 -  Known progressive structural CNS lesion.

 -  History of seizures occurring in predominantly clustered patterns, as determined by
 the Investigator, over the 12 months prior to the Screening Visit (Week -6) or during
 the 6-week prospective baseline period, where individual seizures cannot be counted.

 -  History of status epilepticus within the previous 6 months.

 -  Known history or presence of non-epileptic seizures.

 NOTE; Other protocol defined Inclusion/Exclusion criteria may apply