A Clinical Study of the Safety and Efficacy of Natalizumab in Acute Ischemic Stroke
- Conditions
- Acute Ischemic StrokeMedDRA version: 18.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-004783-11-ES
- Lead Sponsor
- Biogen Idec Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): The secondary endpoints are:<br>- mRS score at Day 90<br>- BI score at Day 90<br>- SIS-16 score at Day 90<br>- MoCA score at Day 90<br>- Safety (incidence and proportion of AEs and SAEs)<br>- NIHSS score at Day 90;Timepoint(s) of evaluation of this end point: - mRS score: Day 90<br>- BI score: Day 90<br>- SIS-16 score: Day 90<br>- MoCA score: Day 90<br>- AEs and SAEs: throughout the study, as necessary<br>- NIHSS score at Day 90