SFX-01 After Subarachnoid Haemorrhage (SAS)
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|ClinicalTrials.gov Identifier: NCT02614742|
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage, Spontaneous||Drug: SFX-01 Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||SFX-01 After Subarachnoid Haemorrhage|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||September 2019|
|Actual Study Completion Date :||November 2019|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614742
|Southampton General Hospital|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Western General Hospital|
|Edinburgh, United Kingdom, EH4 4XU|
|The Royal London Hospital|
|London, United Kingdom, E1 1BB|
|Principal Investigator:||Diederik Bulters, MBChB, BSc||University Hospital Southampton NHS Foundation Trust|