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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003284-38 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SFX-01 | Active Comparator | 300mg bid for up to 28 days. |
|
| Placebo | Placebo Comparator | 300mg placebo bid for up to 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SFX-01 | Drug | An intervention releasing sulforaphane. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 28 days |
| Maximum CSF Concentration [Cmax], | To detect the presence of SFN in Cerebrospinal Fluid (CSF) | 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). | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 180 days post ictus |
| Plasma PK |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diederik Bulters, MBChB, BSc | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southampton General Hospital | Southampton | Hampshire | SO16 6YD | United Kingdom | ||
| Western General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39028412 | Derived | 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. | |
| 32217557 | Derived |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D003505 | Cyclodextrins |
| ID | Term |
|---|---|
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
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| Placebo | Drug | Placebo otherwise identical to Active product |
|
|
To determine plasma SFN levels (and its metabolites) with treatment with SFX-01 (300mg bid).
| up to 28 days |
| CSF drug levels | To determine CSF drug levels following treatment with SFX-01 (300mg bid). | 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 | 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. | Up to 28 days |
| Edinburgh |
| EH4 4XU |
| United Kingdom |
| The Royal London Hospital | London | E1 1BB | United Kingdom |
| Zolnourian 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. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
| D011134 | Polysaccharides |