Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
