SFX-01 after subarachnoid haemorrhage
Research type
Research Study
Full title
SFX-01 after subarachnoid haemorrhage
IRAS ID
194973
Contact name
Diederik Bulters
Contact email
Sponsor organisation
Evgen Pharma
Eudract number
2014-003284-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Subarachnoid haemorrhage (SAH) affects approximately 7,000 patients per year in the UK and causes a lot of death and disability in these patients. The usual treatment for these patients is to repair the point of bleeding. The blood clot itself cannot be practically removed and is left to be broken down by the body. In this process the blood clot releases a number of chemicals which are toxic and lead to inflammation of the brain. This inflammation is the cause of a lot of the problems patients suffer.
Sulforaphane is a substance that is released when broccoli is eaten. It has been studied extensively in the laboratory and has been shown to improve outcome after SAH in animals. However on its own SFN has a short shelf life and is not practical for clinical use. When synthetic SFN is mixed with cyclodextrin it forms SFX-01. SFX-01 is stable and on ingestion releases SFN. This study will assess if SFX-01 is safe, gets into the brain and reduces the inflammation after SAH.It will randomise 90 patients who have suffered a severe SAH in the last 48 hours to receive either SFX-01 or placebo tablets for 28 days. They will be monitored closely with blood and cerebrospinal fluid samples and ultrasound recordings while in hospital and will be followed up at 28 days, 3 months and 6 months with assessments of their outcome. They will also have an MRI at 6 months. By the end of this study we will have assessed the safety and tolerability of SFX-01, established how much and how quickly it gets into the brain and have an estimate of how much of a difference it makes to patient outcome. This will allow us to design a future study to definitively ascertain is usefulness in SAH patients
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0019
Date of REC Opinion
4 Feb 2016
REC opinion
Further Information Favourable Opinion