Subarachnoid Hemorrhage, SpontaneousPhase 2SASNCT02614742
SFX-01 After Subarachnoid Haemorrhage
A Phase 2 study testing SFX-01 in people with Subarachnoid Hemorrhage, Spontaneous, run by Evgen Pharma at 3 sites in United Kingdom.
Trial summary
This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in Subarachnoid Haemorrhage, with exploratory evaluations of efficacy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Spontaneous
- What is being tested?
- SFX-01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Apr 2016to Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with radiological evidence of spontaneous SAH
- Fisher grade 3 or 4 on CT
- Definitive treatment of aneurysm has not been ruled out
- Previously living independently
- In the opinion of the investigator, the delay from ictus to randomisation and initiation of trial medication will not exceed 48 hours
- Aged 18 to 80 years
- In the opinion of the investigator it will be possible to obtain Informed Consent from the Patient, Personal Legal Representative or Professional Legal representative within 24 hours of first dose
Who cannot join
- Traumatic SAH
- Fisher grade 1 or 2
- SAH diagnosed on lumbar puncture with no evidence of blood on CT
- Decision not to treat aneurysm has been made
- Plan to withdraw treatment
- Significant kidney disease as defined as plasma creatinine ≥2.5mg/dL (221 µmol/l)
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- Liver disease as defined as total bilirubin ≥2-fold the upper limit of normal; (ULN) as measured by the local laboratory
- Females who are pregnant or lactating.
- Participants enrolled in another interventional research trial in the last 30 days
- Patients for whom it is known, at the time of screening, that clinical follow-up will not be feasible Patients unwilling to use two forms of contraception (one of which being a barrier method) 30 days for men and 90 days for women after last IMP dose
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Western General Hospital
Edinburgh, EH4 4XU
The Royal London Hospital
London, E1 1BB
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
About this study
This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.
Read the 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
- Being tested
- SFX-01, Placebo
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFX-01Drug
Also called Sulforadex
An intervention releasing sulforaphane.
PlaceboDrug
Also called Cyclodextrin
Placebo otherwise identical to Active product
| Study group | Role | What they receive |
|---|---|---|
| SFX-01 | Active comparator | 300mg bid for up to 28 days. Receives: Drug: SFX-01 |
| Placebo | Placebo comparator | 300mg placebo bid for up to 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria
To evaluate the safety of up to 28 days of SFX-01 dosed at up to 96 mg Sulforaphane (SFN) per day
Measured: up to 28 days
Maximum CSF Concentration [Cmax],
To detect the presence of SFN in Cerebrospinal Fluid (CSF)
Measured: up to 28 days
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
To determine if a minimum of 7 days treatment with SFX-01 reduces Middle Cerebral Artery (MCA) peak flow velocity following Subarachnoid Haemorrhage (SAH).
Measured: up to 28 days
Secondary outcomes (5)
modified Rankin Scale
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.
Measured: up to 180 days post ictus
Plasma PK
To determine plasma SFN levels (and its metabolites) with treatment with SFX-01 (300mg bid).
Measured: up to 28 days
CSF drug levels
To determine CSF drug levels following treatment with SFX-01 (300mg bid).
Measured: up to 14 days
Serum Haptoglobin levels
To determine if up to 28 days treatment with SFX-01 increases serum haptoglobin (HP) levels following SAH
Measured: Up to 28 days
Delayed Cerebral Ischaemia
To determine if up to 28 days treatment with SFX-01 can reduce the incidence of Delayed Cerebral Ischaemia (DCI) following SAH.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startApr 2016
- Primary completionSep 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, SpontaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evgen Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diederik Bulters, MBChB, BSc, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614742
- Sponsor's protocol ID
- EVG001SAH
- Other IDs
- 2014-003284-38, 2014
- Acronym
- SAS
- Status last verified
- Jul 2019
- First submitted
- 16 Nov 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zolnourian A, Garland P, Holton P, Arora M, Rhodes J, Uff C, Birch T, Howat D, Franklin S, Galea I, Bulters D. A Randomised Controlled Trial of SFX-01 After Subarachnoid Haemorrhage - The SAS Study. Transl Stroke Res. 2025 Aug;16(4):1031-1043. doi: 10.1007/s12975-024-01278-1. Epub 2024 Jul 19.
PubMed 39028412Zolnourian AH, Franklin S, Galea I, Bulters DO. Study protocol for SFX-01 after subarachnoid haemorrhage (SAS): a multicentre randomised double-blinded, placebo controlled trial. BMJ Open. 2020 Mar 25;10(3):e028514. doi: 10.1136/bmjopen-2018-028514.
PubMed 32217557
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SFX-01 After Subarachnoid Haemorrhage
- ClinicalTrials.gov ID
- NCT02614742
- Acronym / sponsor ID
- SAS / EVG001SAH
- Conditions
- Subarachnoid Hemorrhage, Spontaneous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Evgen PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SFX-01 | Active comparator | Drug: SFX-01300mg bid for up to 28 days. |
| Placebo | Placebo comparator | Drug: Placebo300mg placebo bid for up to 28 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with radiological evidence of spontaneous SAH
- Fisher grade 3 or 4 on CT
- Definitive treatment of aneurysm has not been ruled out
- Previously living independently
- In the opinion of the investigator, the delay from ictus to randomisation and initiation of trial medication will not exceed 48 hours
Key exclusion criteria (10 listed)
- Traumatic SAH
- Fisher grade 1 or 2
- SAH diagnosed on lumbar puncture with no evidence of blood on CT
- Decision not to treat aneurysm has been made
- Plan to withdraw treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SFX-01Also: SulforadexAn intervention releasing sulforaphane. | Drug | SFX-01 |
| PlaceboAlso: CyclodextrinPlacebo otherwise identical to Active product | Drug | Placebo |
Primary outcome
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).
5 secondary outcomes
modified Rankin Scale
Time frame: up to 180 days post ictus
Plasma PK
Time frame: up to 28 days
CSF drug levels
Time frame: up to 14 days
Serum Haptoglobin levels
Time frame: Up to 28 days
Delayed Cerebral Ischaemia
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 39028412Zolnourian A, Garland P, Holton P, Arora M, Rhodes J, Uff C, Birch T, Howat D, Franklin S, Galea I, Bulters D. A Randomised Controlled Trial of SFX-01 After Subarachnoid Haemorrhage - The SAS Study. Transl Stroke Res. 2025 Aug;16(4):1031-1043. doi: 10.1007/s12975-024-01278-1. Epub 2024 Jul 19.
- Derived from this study: PubMed 32217557Zolnourian AH, Franklin S, Galea I, Bulters DO. Study protocol for SFX-01 after subarachnoid haemorrhage (SAS): a multicentre randomised double-blinded, placebo controlled trial. BMJ Open. 2020 Mar 25;10(3):e028514. doi: 10.1136/bmjopen-2018-028514.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diederik Bulters, MBChB, BSc principal investigator
University Hospital Southampton NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SFX-01 in people with Subarachnoid Hemorrhage, Spontaneous, run by Evgen Pharma at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria (time frame: up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02614742, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.