SFX-01 AFTER SUBARACHNOID HAEMORRHAGE

Phase 1

Conditions: Subarachnoid Haemorrhage
MedDRA version: 20.1Level: PTClassification code 10042316Term: Subarachnoid haemorrhageSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-003284-38-GB

Lead Sponsor: Evgen Pharma plc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 90

Inclusion Criteria

1. Patients with radiological evidence of spontaneous aneurysmal SAH
2. Fisher grade 3 or 4 on CT
3. Definitive treatment of aneurysm has not been ruled out
4. Previously living independently
5. In the opinion of the investigator, the delay from ictus to randomisation and initiation of trial medication will not exceed 48 hours
6. Aged 18 to 80 years
7. In the opinion of the investigator it will be possible to obtain Informed Consent from the Patient, Personal Legal Representative or Professional Legal representative within 24 hours of first dose
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1 Traumatic SAH
2 Fisher grade 1 or 2
3 SAH diagnosed on lumbar puncture with no evidence of blood on CT
4 Decision not to treat aneurysm has been made
5 Plan to withdraw treatment
6 Significant kidney disease as defined as plasma creatinine greater than 2.5mg/dL (221 µmol/l)
7 Liver disease as defined as total bilirubin greater than 2-fold the upper limit of normal as measured by the local laboratory
8 Females who are pregnant or lactating.
9 Participants enrolled in another interventional research trial in the last 30 days
10 Patients for whom it is known, at the time of screening, that clinical follow-up will not be feasible
11 Patients unwilling to use two forms of contraception (one of which being a barrier method) 30 days for men and 90 days for women after last IMP dose
12 Known hypersensitivity to any component of a sulforaphane containing product including broccoli