A randomised, double-blind, placebo-controlled, multiple-dose, dose-escalation study of the safety, tolerability, and pharmacokinetics of Lu AA24493 in patients with acute ischemic stroke

Phase 2

Completed

• Conditions: ischemic stroke; 10007963

• Registration Number: NL-OMON32595
• Lead Sponsor: undbeck

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and tolerability, assessed in terms of AEs, clinical safety laboratory<br /><br>tests, vital signs, body weight, and physical examination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Immunogenicity and pharmacokinetics of Lu AA24493. Patient outcome in terms of<br /><br>NIHSS and mRS. Exploration of mechanistic biomarkers in blood for efficacy and<br /><br>safety.</p><br>