Subarachnoid Hemorrhage, Spontaneous Clinical Trial
Official title:
SFX-01 After Subarachnoid Haemorrhage
This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.
The study is a randomised, double-blind, parallel-group design comparing SFX-01 (300 mg)
taken orally as capsules or as a suspension via a nasogastric tube (NG) twice-daily for up to
28 days versus placebo in 90 patients who have had SAH and present within 48 hours of ictus.
Subjects will receive SFX-01/Placebo in order to review potential outcomes investigating the
long-term complications of SAH such as Delayed Cerebral Ischaemia, as reflected by
Trans-Cranial Doppler (TCD) readings. The objective is to demonstrate safety and search for
signals of efficacy in patients that have had SAH.
A sub-study will be conducted in up to 12 patients where an External Ventricular Drain (EVD)
fitted; serial CSF samples will be taken pre- & post-dose on two occasions to determine
pharmacokinetics of Sulforaphane in CSF in comparison with plasma pharmacokinetics. Sub-study
patients will undergo all other procedures (with the exception of lumbar puncture).
Treatment duration is up to 28 days; follow up duration is 28 days, three and six months. The
planned trial period is 24 months.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06218654 -
Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage
|
||
| Completed |
NCT04357626 -
Determinants of Rehabilitation Outcomes in Survivors of Primary Subarachnoid Haemorrhage
|