ischemic stroke
Conditions
Interventions
Multiple dose (5 daily dosages on consecutive days) 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 at the start of treatment; stable condition; treatment can be initiated 0-48 hours after onset of stroke symptoms; acceptance of hospital stay of at least 120 hours after first IMP dose (for full inclusion criteria refer to study protocol, page 28)
Exclusion criteria
Exclusion criteria: Treatment with a thrombolytic within the previous 24 hours; previous treatment with erythropoietin of Lu AA24493; score >0 on the NIHSS consciousness item; pre-stroke mRS score >1, indicating previous disability; uncontrolled hypertension; history or imaging evidence of various CNS abnormalities (for further details, 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. Exploration of mechanistic biomarkers in blood for efficacy and safety. | — |
Countries
Netherlands
Outcome results
None listed