A randomised, double blind clinical trial investigating the safety and tolerability of multiple increasing doses of EDV2209 compared to placebo (a salt solution that looks like EDV2209 but do not contain any active substance) in patients with bleeding in the brain (subarachnoid haemorrhage- SAH)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Edvince AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

10 Mar 2022 → ongoing

Decision date (initial)

2024-07-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-514590-22-00

EudraCT number

2021-003629-31

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Dose response, Efficacy, Safety

Safety and tolerability of EDV2209 in patients with non-traumatic SAH who receive at least one dose of IMP

Secondary objectives 3

1. To assess the clinical outcome in patients with SAH treated with EDV2209.
2. To assess the length of stay in the NICU, in the Neurosurgical Stepdown Unit, and in hospital for patients with subarachnoid haemorrhage (SAH) treated with EDV2209.
3. To evaluate the pharmacokinetic properties of EDV2209

Conditions and MedDRA coding

Subarachnoid haemorrhage – SAH

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Male or female patients aged 18-80 years (both inclusive)
2. 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
3. Intracerebroventricular access obtained within 8 h from start of symptoms
4. A WFNS score 1-5, assessed at any time after SAH diagnosis, but before first dose of IMP
5. Informed consent obtained from a trial guardian prior to initiation of any trial-related procedures.

Exclusion criteria 8

1. The SAH due to other causes (e.g., trauma, rupture of fusiform or mycotic aneurysms)
2. Intraventricular or intracerebral blood, in the absence of subarachnoid blood
3. Expected survival < 48 hours
4. 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
5. 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
6. Participation in any other clinical trial with an experimental drug within the last 12 weeks
7. Known allergy to the IMP or its constituents
8. Female patients who are pregnant or breastfeeding. Women of childbearing potential must have a negative plasma or urine pregnancy test at screening

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Frequency of TEAEs, SAEs and severe TEAEs, change from baseline in vital signs, laboratory results, OS

Secondary endpoints 4

1. Clinical outcomes as measured by: a. National Institute of Health Stroke Scale (NIHSS) on Day 14 or at discharge, whichever comes first. b. Modified Rankin Scale (mRS) at discharge from the NICU or the Neurosurgical Stepdown Unit, Day 28 and 84 after SAH. c. Extended Glasgow Outcome Scale (GOS-E) at discharge from neurosurgical care, Day 28 and 84 after SAH
2. Number of days spent in NICU, the Neurosurgical Stepdown Unit, in hospital of trial site, and (if transferred) in any hospital
3. Pharmacokinetic endpoints: a. Plasma: i. Maximum (peak) concentration (Cmax) ii. Nominal time for the occurrence of Cmax (Tmax) iii. Area under the concentration-time curve from 0 to time t (AUC0-t)
4. Pharmacokinetic endpoints: b. CSF: i. Concentration of EDV2209 at the selected sampling times ii. Concentration of EDV2209 at the selected sampling times relative to the plasma concentrations of EDV2209 at the same time points (CSF/plasma ratios) iii.Maximum (peak) concentration (Cmax) iv.Nominal time for the occurrence of Cmax (Tmax) v.Area under the concentration-time curve from 0 to time t (AUC0-t)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Edvince AB

Sponsor organisation

Edvince AB

Address

Medicon Village

City

Lund

Postcode

223 81

Country

Sweden

Scientific contact point

Organisation

Edvince AB

Contact name

Jan Alenfall

Public contact point

Organisation

Edvince AB

Contact name

Jan Alenfall

Third parties 5

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications