Clinical study to investigate the effect of EDV2209 in patients with a bleeding in the brai
- Conditions
- Subarachnoid haemorrhage – SAHMedDRA version: 21.1Level: PTClassification code: 10042316Term: Subarachnoid haemorrhage Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2024-514590-22-00
- Lead Sponsor
- Edvince AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 27
Male or female patients aged 18-80 years (both inclusive), Moderate or severe SAH diagnosed with CT and caused (or suspected to be caused) by a ruptured saccular aneurysm with symptoms less than 8 hours, Intracerebroventricular access obtained within 8 h from start of symptoms, A WFNS score 1-5, assessed at any time after SAH diagnosis, but before first dose of IMP, Informed consent obtained from a trial guardian prior to initiation of any trial-related procedures.
The SAH due to other causes (e.g., trauma, rupture of fusiform or mycotic aneurysms), Intraventricular or intracerebral blood, in the absence of subarachnoid blood, Expected survival < 48 hours, Any severe or unstable chronic or acute concomitant condition, which, in the opinion of the PI/delegate, would affect the assessment of the safety of the IMP, Any known or CT evidence of previous major cerebral damage or preexisting cerebrovascular disorders, which in the opinion of the PI/delegate may affect the accurate diagnosis and evaluation of SAH, Participation in any other clinical trial with an experimental drug within the last 12 weeks, Known allergy to the IMP or its constituents, Female patients who are pregnant or breastfeeding. Women of childbearing potential must have a negative plasma or urine pregnancy test at screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method