FINISHER - Anti-inflammatory therapy after aneurysmal subarachnoid haemorrhage to improve treatment outcome

Phase 1

• Conditions: aneurysmal subarachnoid hemorrhage; MedDRA version: 21.1Level: PTClassification code 10042316Term: Subarachnoid haemorrhageSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-000732-54-DE
• Lead Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-09
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 184
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1.SAH due to any other cause than aneurysm rupture (e.g. traumatic, arteriovenous malfor-mation (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 condi-tion which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s par-ticipation in this clinical trial
6.Current positive pregnancy test (e.g. ß-HCG test in serum)
7.Known history of hypersensitivity to the inves-tigational drug or to drugs with a similar chemical structure
8.Severe infectious diseases (in discretion of the local investigator by clinical and laboratory pa-rameters 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified