ischemic stroke
Conditions
Interventions
One single dose of Lu AA24493 or placebo, administered as an IV infusion.
Sponsors
Lundbeck
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male or female patients, aged 50-90 years; clinical diagnosis of acute ischemic stroke; measurable stroke-related deficit, present at start of treatment; stable condition; treatment can be initiated 12 - 48 hours after onset of stroke symptoms; expected hospital stay of at least 72 hours after IMP administration. (for full inclusion criteria refer to study protocol, page 27)
Exclusion criteria
Exclusion criteria: Patient has been treated with a thrombolytic within the previous 24 hours; score > 0 on the NIHSS consciousness item; life expectancy 1 (indicating previous disability); uncontrolled hypertension; history, clinical presentation or imaging evidence of various CNS abnormalities (for further specification, and full exclusion criteria refer to study protocol, page 28)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability, assessed in terms of AEs, clinical safety laboratory tests, vital signs, body weight, and physical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity and pharmacokinetics of Lu AA24493. Patient outcome in terms of NIHSS and mRS. | — |
Countries
Netherlands
Outcome results
None listed