NCT02614742: SAS

SFX-01 After Subarachnoid Haemorrhage

Completed Phase 2 Last updated 14 January 2020

What this trial tests

Phase 2 trial testing SFX-01 in Subarachnoid Hemorrhage, Spontaneous in 90 participants. Completed in 1 November 2019.

Timeline

1 April 2016

Primary endpoint
1 September 2019

1 November 2019

Quick facts

Lead sponsor	Evgen Pharma
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	90
Start date	1 April 2016
Primary completion	1 September 2019
Estimated completion	1 November 2019
Sites	3 locations across United Kingdom

Drugs / interventions tested

• SFX-01 — full drug profile →
• Placebo

Conditions studied

• Subarachnoid Hemorrhage, Spontaneous — all drugs for Subarachnoid Hemorrhage, Spontaneous →

Sponsor

Evgen Pharma — full company profile →

Who can join

Adults 18 to 80, any sex, with Subarachnoid Hemorrhage, Spontaneous. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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).

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Natural products in drug discovery: advances and opportunities.
   Atanasov AG, Zotchev SB, Dirsch VM, International Natural Product Sciences Taskforce, et al · · 2021 · cited 2988× · PMID 33510482 · DOI 10.1038/s41573-020-00114-z
2. Activators and Inhibitors of NRF2: A Review of Their Potential for Clinical Development.
   Robledinos-Antón N, Fernández-Ginés R, Manda G, Cuadrado A. · · 2019 · cited 443× · PMID 31396308 · DOI 10.1155/2019/9372182
3. Can Activation of NRF2 Be a Strategy against COVID-19?
   Cuadrado A, Pajares M, Benito C, Jiménez-Villegas J, et al · · 2020 · cited 168× · PMID 32711925 · DOI 10.1016/j.tips.2020.07.003
4. Recent Advances in Understanding Nrf2 Agonism and Its Potential Clinical Application to Metabolic and Inflammatory Diseases.
   Kim MJ, Jeon JH. · · 2022 · cited 60× · PMID 35269986 · DOI 10.3390/ijms23052846
5. Targeting NLRP3 Inflammasome With Nrf2 Inducers in Central Nervous System Disorders.
   Tastan B, Arioz BI, Genc S. · · 2022 · cited 56× · PMID 35418995 · DOI 10.3389/fimmu.2022.865772
6. Impaired antioxidant KEAP1-NRF2 system in amyotrophic lateral sclerosis: NRF2 activation as a potential therapeutic strategy.
   Bono S, Feligioni M, Corbo M. · · 2021 · cited 56× · PMID 34663413 · DOI 10.1186/s13024-021-00479-8
7. Transcriptional activation of antioxidant gene expression by Nrf2 protects against mitochondrial dysfunction and neuronal death associated with acute and chronic neurodegeneration.
   Goodfellow MJ, Borcar A, Proctor JL, Greco T, et al · · 2020 · cited 53× · PMID 32061629 · DOI 10.1016/j.expneurol.2020.113247
8. Neuroprotective Role of the Nrf2 Pathway in Subarachnoid Haemorrhage and Its Therapeutic Potential.
   Zolnourian A, Galea I, Bulters D. · · 2019 · cited 50× · PMID 31191800 · DOI 10.1155/2019/6218239