SFX-01 After Subarachnoid Haemorrhage

NCT02614742 | Completed Phase 2 DMC

• 2 other identifiers: EVG001SAH2014-003284-38
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Subarachnoid Hemorrhage, Spontaneous

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• modified Rankin Scale

  up to 180 days post ictus

• Plasma PK

  up to 28 days

• CSF drug levels

  up to 14 days

• Serum Haptoglobin levels

  Up to 28 days

• Delayed Cerebral Ischaemia

  Up to 28 days

Study Arms (2)

SFX-01

ACTIVE COMPARATOR

300mg bid for up to 28 days.

Drug: SFX-01

Placebo

PLACEBO COMPARATOR

300mg placebo bid for up to 28 days

Drug: Placebo

Interventions

SFX-01 DRUG

An intervention releasing sulforaphane.

Also known as: Sulforadex

SFX-01

Placebo DRUG

Placebo otherwise identical to Active product

Also known as: Cyclodextrin

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Evgen Pharma: lead

Study Sites (3)

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 4XU, United Kingdom

Location

The Royal London Hospital

London, E1 1BB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39028412 DERIVED

• 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.

  PMID: 32217557 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Cyclodextrins

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Officials

• Diederik Bulters, MBChB, BSc

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 25, 2015
• Study Start: April 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2019-07

Locations

GB (3)