Enrolling Now - 6
BIOGEN 101EP201
101EP201: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Exploring the Efficacy, Safety, and Tolerability of Natalizumab (BG00002) as Adjunctive Therapy in Adult Subjects With Drug-Resistant Focal Epilepsy
PI: Marcelo Lancman, MD
Northeast Regional Epilepsy Group
KEY INCLUSION CRITERIA
* Aged 18-75 inclusive, at the time of informed consent
* Must have focal epilepsy diagnosed on clinical grounds and as applicable supported by EEG findings and brain imaging. Subject with multifocal epilepsy may be included if all other entry criteria are met.
* Experiences 6 or more seizures during the 6-weeks prospective baseline period and is not seizure free for more than 21 consecutive days during the prospective baseline period. Seizures included in counts are simple partial with motor signs, complex partial seizures, and focal to bilateral tonic-clonic seizures
* Stable on 1 to 5 AEds with no modification of dosing within 4 weeks prior to screening. Dosing regimen must also be stable through out 6-weeks prospective baseline period. Benzodiazepines used on a regular basis for another indication is counted towards an AEDRNS and VNS are allowed and implantation must have occurred at least 6 months prior to the screening.
EXCLUSION CRITERIA
* Diagnosis of generalized-combined generalized and focal, or unknown epilepsy.
* History of uncountable seizure over the 12 months prior to the screening visit or during the 6-weeks prospective baseline period.
* Known planned epilepsy surgery or admission to the epilepsy monitoring unit with intended drug change within 12 months of week 0.
* A clinically significant infectious illness (e.g cellulitis, abscess, pneumonia, septicaemia, tuberculosis) within 3 months prior to randomization, or PML or other opportunistic infections at any time.
* History of drug or alcohol abuse ( as defined by the investigator) within 2 years prior to the screening visit. Stable Cannabinoid use is allowed if started at least 4 weeks prior to the screening visit and must be documented.
* History of malignant disease including solid tumors and hematologic malignancies ( with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured.
* Symptoms of bacterial, fungal, or viral infection (including upper respiratory tract infection) within 14 days prior to randomization