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SFX01 After Subarachnoid Haemorrhage (SAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Evgen Pharma
Sponsor:
Information provided by (Responsible Party):
Evgen Pharma
ClinicalTrials.gov Identifier:
NCT02614742
First received: November 16, 2015
Last updated: April 27, 2016
Last verified: April 2016
  Purpose
This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.

Condition Intervention Phase
Subarachnoid Hemorrhage, Spontaneous
Drug: SFX-01
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SFX-01 After Subarachnoid Haemorrhage

Resource links provided by NLM:


Further study details as provided by Evgen Pharma:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • modified Rankin Scale [ Time Frame: up to 180 days post ictus ]
    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.

  • Plasma PK [ Time Frame: up to 28 days ]
    To determine plasma SFN levels (and its metabolites) with treatment with SFX-01 (300mg bid).

  • CSF drug levels [ Time Frame: up to 14 days ]
    To determine CSF drug levels following treatment with SFX-01 (300mg bid).

  • Serum Haptoglobin levels [ Time Frame: Up to 28 days ]
    To determine if up to 28 days treatment with SFX-01 increases serum haptoglobin (HP) levels following SAH

  • Delayed Cerebral Ischaemia [ Time Frame: Up to 28 days ]
    To determine if up to 28 days treatment with SFX-01 can reduce the incidence of Delayed Cerebral Ischaemia (DCI) following SAH.


Estimated Enrollment: 90
Study Start Date: April 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SFX-01
300mg bid for up to 28 days.
Drug: SFX-01
An intervention releasing sulforaphane.
Other Name: Sulforadex
Placebo Comparator: Placebo
300mg placebo bid for up to 28 days
Drug: Placebo
Placebo otherwise identical to Active product
Other Name: Cyclodextrin

Detailed 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.

The treatment group will receive SFX-01 in order to improve outcome and reduce 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02614742

Contacts
Contact: David W Howat, PhD, BSc +441517053532 d.howat@evgen.com

Locations
United Kingdom
Southampton General Hospital Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Diederik Bulters    07980596273    dbulters@nhs.net   
Sponsors and Collaborators
Evgen Pharma
Investigators
Principal Investigator: Diederik Bulters, MBChB, BSc University Hospital Southampton NHS Foundation Trust
  More Information

Responsible Party: Evgen Pharma
ClinicalTrials.gov Identifier: NCT02614742     History of Changes
Other Study ID Numbers: EVG001SAH
2014-003284-38 ( EudraCT Number )
Study First Received: November 16, 2015
Last Updated: April 27, 2016

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 25, 2017