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    Summary
    EudraCT Number:2014-003284-38
    Sponsor's Protocol Code Number:EVG001SAH
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-003284-38
    A.3Full title of the trial
    SFX-01 AFTER SUBARACHNOID HAEMORRHAGE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SFX-01 AFTER SUBARACHNOID HAEMORRHAGE
    A.3.2Name or abbreviated title of the trial where available
    SAS
    A.4.1Sponsor's protocol code numberEVG001SAH
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02614742
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEvgen Pharma plc
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEvgen Pharma PLC
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEvgen Pharma plc
    B.5.2Functional name of contact pointClinical trials Information
    B.5.3 Address:
    B.5.3.1Street Address146 Brownlow Hill
    B.5.3.2Town/ cityLiverpool
    B.5.3.3Post codeL3 5RF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441517053532
    B.5.6E-mailclinical_info@evgen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSulforadex
    D.3.2Product code SFX-01
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSulforadex
    D.3.9.1CAS number 1039704-32-9
    D.3.9.2Current sponsor codeSFX-01
    D.3.9.3Other descriptive namesulforaphane alpha cyclodextrin complex
    D.3.9.4EV Substance CodeSUB89998
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subarachnoid Haemorrhage
    E.1.1.1Medical condition in easily understood language
    subarachnoid haemorrhage in British English, is bleeding into the subarachnoid space—the area between the arachnoid membrane and the pia mater surrounding the brain.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10042316
    E.1.2Term Subarachnoid haemorrhage
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety of up to 28 days of SFX-01 dosed at up to 600mg (92mg Sulforaphane) per day.

    To detect the presence of SFN in Cerebrospinal Fluid (CSF).

    To determine if a minimum of 7 days treatment with SFX-01 reduces Middle Cerebral Artery (MCA) peak flow velocity following subarachnoid haemorrhage (SAH).
    E.2.2Secondary objectives of the trial
    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 days, discharge, 28, 90 and 180 days post ictus.
    To determine blood SFN levels (and its metabolites) with treatment with SFX-01 (300mg bid).
    To determine CSF SFN levels and kinetics with treatment with SFX-01 (300mg bid).
    To determine if up to 28 days treatment with SFX-01 increases blood haptoglobin (HP) levels and decreases malondialdehyde (MDA) levels following SAH.
    To determine if up to 28 days treatment with SFX-01 can reduce the incidence of Delayed Cerebral Ischaemia (DCI) following SAH.
    To determine if up to 28 days treatment with SFX-01 improves long-term outcome in subjects following SAH.
    To determine if up to 28 days of treatment with SFX-01 can reduce iron deposition and cortical atrophy following SAH.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic sub-study
    A group of up to 12 patients, all of whom have been fitted with an EVD as part of their normal treatment, will be selected for a pharmacokinetic sub-study. Additional patient consent will be required for the sub-study;
    The patients will, in addition to all other procedures (with the exception of lumbar puncture), undergo serial CSF sampling (1 sample pre dose and hourly for 6 hours post dose) at first dose and day 7. If the EVD is fitted after first dose, serial sampling will only take place at day 7.
    E.3Principal inclusion criteria
    1. Patients with radiological evidence of spontaneous aneurysmal 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
    E.4Principal 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 greater than 2.5mg/dL (221 μmol/l)
    7 Liver disease as defined as total bilirubin greater than 2-fold the upper limit of normal 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
    11 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
    12 Known hypersensitivity to any component of a sulforaphane containing product including broccoli
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    Concomitant medication
    Adverse events
    Change in grading of AE severity
    FBC, U&Es, LFT, CRP & Urine Microscopy
    INR or PT, APTR or APTT & Fibrinogen (Clauss or Derived) at 7 & 28 days
    E.5.1.1Timepoint(s) of evaluation of this end point
    Concomitant medicationn, Common Toxicity Criteri & Adverse events - Continuous
    FBC, U&Es, LFT, CRP & Urine Microscopy to day 28
    INR or PT, APTR or APTT & Fibrinogen (Clauss or Derived) at 7 & 28 days
    E.5.2Secondary end point(s)
    Incidence of Delayed Cerebral Ischaemia (DCI) defined as a new focal deficit or reduction in Glasgow Coma Scale (GCS) > or = 2 if not explained by other cause As clinically required
    Incidence of new cerebral infarct on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) As clinically indicated
    Institution of hypertensive (triple H) therapy for presumed DCI
    Modified Rankin Scale (mRS), at 7 days, discharge, 28, 90 and 180 days.
    SF-36 quality of life survey at 28, 90 & 180 days.
    Checklist for Cognitive and Emotional Consequences (CLCE-24), Brain Injury, Community Rehabilitation Outcomes Scale (BICRO-39), 90 & 180 days.
    Length of acute hospital stay
    Discharge location
    Amount of iron identified on MRI- 180 days after start of treatment.
    Cortical atrophy on T1 MRI at 180 days after start of treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Incidence of Delayed Cerebral Ischaemia (DCI) As clinically required
    Incidence of new cerebral infarct why (CT) or (MRI) As clinically indicated
    Institution of hypertensive (triple H) therapy for presumed DCI to day 28
    Modified Rankin Scale (mRS), at 7 days, discharge, 28, 90 and 180 days.
    SF-36 quality of life survey at 28, 90 & 180 days.
    Checklist for Cognitive and Emotional Consequences (CLCE-24), Brain Injury, Community Rehabilitation Outcomes Scale (BICRO-39), 90 & 180 days.
    Length of acute hospital stay
    Discharge location
    Amount of iron identified on MRI- 180 days after start of treatment.
    Cortical atrophy on T1 MRI at 180 days after start of treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For patients that were unconscious at screening,

    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-07
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