CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 277 enrolled
Drug / intervention
natalizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02730455
NCT02730455Phase 2Completed
CompareCT.gov

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

Biogen·interventional·Posted Apr 6, 2016·Updated Jan 8, 2019

In Brief

A Phase 2 clinical trial evaluating natalizumab and Placebo for Acute Ischemic Stroke. Completed, enrolled 277 participants across 53 sites in 4 countries.

Detailed Summary

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. The secondary objective of the study is to explore dose and exposure response and the clinical treatment effects of natalizumab versus placebo in acute ischemic stroke on the following: measures of independence, activities of daily living, neurologic function, quality of life, cognition, and safety and tolerability

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Ischemic Stroke
CountriesGermany, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 6, 2016
Enrollment StartJul 18, 2016
Primary CompletionNov 20, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.2 years ago

Interventions

natalizumabdrug

Administered as specified in the treatment arm

Placebodrug

Matched placebo