SFX01 After Subarachnoid Haemorrhage (SAS)
|Subarachnoid Hemorrhage, Spontaneous||Drug: SFX-01 Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||SFX-01 After Subarachnoid Haemorrhage|
- Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria [ Time Frame: up to 28 days ]To evaluate the safety of up to 28 days of SFX-01 dosed at up to 96 mg Sulforaphane (SFN) per day
- Maximum CSF Concentration [Cmax], [ Time Frame: up to 28 days ]To detect the presence of SFN in Cerebrospinal Fluid (CSF)
- Number of participants with treatment related reduction in middle cerebral artery (MCA) peak flow velocity following Subarachnoid Haemorrhage (SAH) measured by trans cranial doppler ultrasound [ Time Frame: up to 28 days ]To determine if a minimum of 7 days treatment with SFX-01 reduces Middle Cerebral Artery (MCA) peak flow velocity following Subarachnoid Haemorrhage (SAH).
- modified Rankin Scale [ Time Frame: up to 180 days post ictus ]To determine if a minimum of 7 days treatment with SFX-01 improves clinical outcome following SAH as measured using the modified Rankin Scale assessed at 7 , 28, 90 and 180 days post ictus.
- Plasma PK [ Time Frame: up to 28 days ]To determine plasma SFN levels (and its metabolites) with treatment with SFX-01 (300mg bid).
- CSF drug levels [ Time Frame: up to 14 days ]To determine CSF drug levels following treatment with SFX-01 (300mg bid).
- Serum Haptoglobin levels [ Time Frame: Up to 28 days ]To determine if up to 28 days treatment with SFX-01 increases serum haptoglobin (HP) levels following SAH
- Delayed Cerebral Ischaemia [ Time Frame: Up to 28 days ]To determine if up to 28 days treatment with SFX-01 can reduce the incidence of Delayed Cerebral Ischaemia (DCI) following SAH.
|Study Start Date:||April 2016|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Active Comparator: SFX-01
300mg bid for up to 28 days.
An intervention releasing sulforaphane.
Other Name: Sulforadex
Placebo Comparator: Placebo
300mg placebo bid for up to 28 days
Placebo otherwise identical to Active product
Other Name: Cyclodextrin
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.
The treatment group will receive SFX-01 in order to improve outcome and reduce 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02614742
|Contact: David W Howat, PhD, BScfirstname.lastname@example.org|
|Southampton General Hospital||Recruiting|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Contact: Diederik Bulters 07980596273 email@example.com|
|Principal Investigator:||Diederik Bulters, MBChB, BSc||University Hospital Southampton NHS Foundation Trust|