BIP_101SK202_PSVMC

BIP 101SK202 PSVMC-Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) in Acute Ischemic Stroke

The primary objective of the study is to assess the clinical effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of functional independence and activities of daily living.

Key Eligibilities:
-Patients ages 18 to 80 with a clinical diagnosis of supratentorial acute ischemic stroke defined by last known normal ≤ 9 hours prior to study treatment initiation.
-NIHSS score of 5 to 23 point, inclusive, at screening.
-Prior to index stroke, patient was able to perform basic activities of daily living without assistance.
-For those subjects who underwent a cranial MRI, at least 1 acute infarct with a diameter of ≥2 cm on baseline brain diffusion-weighted imaging.

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Phase II
NCT02730455
Neurosciences, All Other
Stroke
Ted Lowenkopf, M.D.
Biogen Idec
Kristen Reid
  • Providence St. Vincent Medical Center