SFX-01 After Subarachnoid Haemorrhage (SAS)

E

Evgen Pharma

Status and phase

Completed
Phase 2

Conditions

Subarachnoid Hemorrhage, Spontaneous

Treatments

Drug: SFX-01
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02614742
EVG001SAH
2014-003284-38 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 2 patient groups, including a placebo group

SFX-01
Active Comparator group
Description:
300mg bid for up to 28 days.
Treatment:
Drug: SFX-01
Placebo
Placebo Comparator group
Description:
300mg placebo bid for up to 28 days
Treatment:
Drug: Placebo

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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