FINISHER – Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Neoplasms [C04]

Trial duration

24 Nov 2021 → 9 Sep 2025

Decision date (initial)

2024-05-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512314-17-00

EudraCT number

2021-000732-54

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To analyze impact on outcome of an anti-inflammatory treatment with dexamethasone in patients with acute aneurysmal subarachnoid hemorrhage with or without an initial inflammatory signature in peripheral blood compared to placebo.

Secondary objectives 7

1. Analysis of improvement in survival rate
2. Analysis of improvement in recovery time in patients receiving dexamethasonen after aSAH
3. Analysis of delayed ischemic neurological deficit (DIND)
4. Analysis of symptomatic vasospasm
5. Analysis of inflammation parameters
6. Evaluation of quality of life (QoL)
7. Safety analysis of dexamethasone for treatment in patients suffering from SAH

Conditions and MedDRA coding

Aneurysmal Subarachnoid Hemorrhage (SAH)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Male or female subjects, equal or older than 18 years old
2. Written consent to participate in the study by the patient or his legal representative (emergency inclusion by next of kin or consultant physician under the responsibility of the principal investigator is possible))
3. Confirmed diagnosis of aneurysmal SAH and onset within 48 hours before inclusion

Exclusion criteria 12

1. SAH due to any other cause than aneurysm rupture (e.g. traumatic, arteriovenous malformation (AVM), fistula, dissection)
2. Any condition that, in the judgement of the Investigator, could impose hazards to the patient if study therapy is initiated or affects the participation of the patient in the study
3. Patients with obvious evidence of irreparable brainstem or thalamic injury
4. Patients with foreseeable difficulties to attend follow-ups adequately
5. Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
6. Current positive pregnancy test (e.g. β-HCG test in serum)
7. Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
8. Severe infectious diseases (in discretion of the local investigator by clinical and laboratory parameters e.g. CRP, PCT, WBC, IL-6)
9. Known angle-closure or open angle glaucoma
10. Known ulceration in the gastro-intestinal tract
11. History of gastro-intestinal bleeding
12. Long-term treatment with corticosteroids prior SAH

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Comparison of combined mortality and severe disability between study arms, assessed by the modified Rankin Scale (mRS) 6 months after the subarachnoid hemorrhage - dichotomized in “favourable (mRS 0-3) versus “unfavourable“ (mRS 4-6) outcome.

Secondary endpoints 7

1. a) Analysis of mortality at 7, 90 and 365 days after aSAH b) Comparison of time of death in patients
2. Length of ICU stay and hospitalization after aSAH
3. Delayed ischemic neurological deficit (DIND)
4. Symptomatic vasospasm measured by transcranial doppler / computed tomography scans / MR angiography / angiography
5. Level of inflammation parameters such as CRP, PCT, WBC, IL-6 in serum
6. Analysis of SF36 scores and EQ-ED scores in patients on discharge and at 90, 180 and 365 days after aSAH
7. Analysis of AEs by number, severity, relationship

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Sponsor organisation

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Address

Venusberg-Campus 1, Venusberg Venusberg

City

Bonn

Postcode

53127

Country

Germany

Scientific contact point

Organisation

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Contact name

Prof. Dr. Erdem Güresir

Public contact point

Organisation

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Contact name

Prof. Dr. Erdem Güresir

Third parties 1

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

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

Application history

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