A Clinical Study of the Safety and Efficacy of Natalizumab in Acute Ischemic Stroke

A 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004783-11-ES

Enrollment

240

Registered

2016-02-17

Start date

2016-04-26

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke MedDRA version: 18.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000004852

Interventions

Trade Name: TYSABRI Product Name: AN100226, BG00002 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: NATALIZUMAB CAS Number: 189261-10-7 Concentration unit: mg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ?9 hours prior to study treatment initiation - Score of 5 to 23 points, inclusive, on the NIHSS 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, there is at least 1 acute infarct with a diameter of ?2 cm on baseline brain diffusion-weighted imaging NOTE: Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 190 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: - Rapidly improving or minor stroke symptoms - Lacunar or isolated brainstem stroke based on clinical assessment and available acute imaging studies - Presence of acute intracranial hemorrhage on acute brain CT or MRI - Severe stroke NOTE: Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to assess the effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of independence and activities of daily life;Secondary Objective: 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, and cognition and safety and tolerability.;Primary end point(s): The primary efficacy endpoint is a composite global measure of functional disability based on a score of 0 or 1 on the mRS and a score of ?95 on the BI at Day 90;Timepoint(s) of evaluation of this end point: Day 90	—

Measure

Time frame

Main Objective: The primary objective of the study is to assess the effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of independence and activities of daily life;Secondary Objective: 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, and cognition and safety and tolerability.;Primary end point(s): The primary efficacy endpoint is a composite global measure of functional disability based on a score of 0 or 1 on the mRS and a score of ?95 on the BI at Day 90;Timepoint(s) of evaluation of this end point: Day 90

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints are: - mRS score at Day 90 - BI score at Day 90 - SIS-16 score at Day 90 - MoCA score at Day 90 - Safety (incidence and proportion of AEs and SAEs) - NIHSS score at Day 90;Timepoint(s) of evaluation of this end point: - mRS score: Day 90 - BI score: Day 90 - SIS-16 score: Day 90 - MoCA score: Day 90 - AEs and SAEs: throughout the study, as necessary - NIHSS score at Day 90	—

Measure

Time frame

Secondary end point(s): The secondary endpoints are: - mRS score at Day 90 - BI score at Day 90 - SIS-16 score at Day 90 - MoCA score at Day 90 - Safety (incidence and proportion of AEs and SAEs) - NIHSS score at Day 90;Timepoint(s) of evaluation of this end point: - mRS score: Day 90 - BI score: Day 90 - SIS-16 score: Day 90 - MoCA score: Day 90 - AEs and SAEs: throughout the study, as necessary - NIHSS score at Day 90

—

Countries

Germany, Spain, United Kingdom, United States

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026