SFX-01 After Subarachnoid Haemorrhage

Subarachnoid Hemorrhage, Spontaneous Clinical Trial

— SAS  

Official title:

SFX-01 After Subarachnoid Haemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614742
• Other study ID #: EVG001SAH
• Secondary ID: 2014-003284-38
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: November 2019

Study information

• Verified date: July 2019
• Source: Evgen Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients with radiological evidence of spontaneous SAH

2. Fisher grade 3 or 4 on CT

3. Definitive treatment of aneurysm has not been ruled out

4. Previously living independently

5. In the opinion of the investigator, the delay from ictus to randomisation and initiation of trial medication will not exceed 48 hours

6. Aged 18 to 80 years

7. 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:

1. Traumatic SAH

2. Fisher grade 1 or 2

3. SAH diagnosed on lumbar puncture with no evidence of blood on CT

4. Decision not to treat aneurysm has been made

5. Plan to withdraw treatment

6. Significant kidney disease as defined as plasma creatinine =2.5mg/dL (221 µmol/l)

7. Liver disease as defined as total bilirubin =2-fold the upper limit of normal; (ULN) as measured by the local laboratory

8. Females who are pregnant or lactating.

9. Participants enrolled in another interventional research trial in the last 30 days

10. 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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Spontaneous

Intervention

Drug:
• SFX-01
An intervention releasing sulforaphane.
• Placebo
Placebo otherwise identical to Active product

Locations

Country	Name	City	State
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	The Royal London Hospital	London
United Kingdom	Southampton General Hospital	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Evgen Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum CSF Concentration [Cmax],	To detect the presence of SFN in Cerebrospinal Fluid (CSF)	up to 28 days
Primary	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	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
Secondary	Plasma PK	To determine plasma SFN levels (and its metabolites) with treatment with SFX-01 (300mg bid).	up to 28 days
Secondary	CSF drug levels	To determine CSF drug levels following treatment with SFX-01 (300mg bid).	up to 14 days
Secondary	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
Secondary	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