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

Phase 1

• Conditions: Acute Ischemic Stroke; MedDRA version: 19.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-004783-11-GB
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-30
• Study Completion: 2017-11-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 277

Inclusion Criteria

- Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN =24 hours prior to study treatment initiation.
- Score of 5 to 23 points, inclusive, on the NIHSS at Screening for
subjects initiating treatment =9 hours from LKN. Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization.
- Score of 5 to 15 points, inclusive, on the NIHSS at Screening for subjects initiating treatment >9 to =24 hours from LKN. Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization.
- Prior to index stroke, patient was able to perform basic activities of daily living without assistance: dressing, eating, walking, bathing, and using the toilet.
- 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

- Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care.
- Presence of acute intracranial hemorrhage on acute brain CT or MRI. However, petechial hemorrhages of =1 cm are not exclusionary.
- Severe stroke
- Seizure at the onset of stroke.
- Known history of prior treatment with natalizumab.
- Known history of active viral hepatitis B or C.
- Signs and symptoms of active or acute infection.
NOTE: Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified