NCT02614742

SFX-01 After Subarachnoid Haemorrhage

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Evgen Pharma · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.

Detailed description

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.

Conditions

• Subarachnoid Hemorrhage, Spontaneous

Interventions

Type	Name	Description
DRUG	SFX-01	An intervention releasing sulforaphane.
DRUG	Placebo	Placebo otherwise identical to Active product

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-09-01
• Completion: 2019-11-01
• First posted: 2015-11-25
• Last updated: 2020-01-18

Locations

3 sites across 1 country: United Kingdom