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    Summary
    EudraCT Number:2011-005616-29
    Sponsor's Protocol Code Number:FOCUS2012
    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:2012-01-06
    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 number2011-005616-29
    A.3Full title of the trial
    A multicentre randomised trial to establish the effect(s) of routine administration of Fluoxetine for six months in patients with a recent stroke
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fluoxetine or placebo for patients with a recent stroke
    A.3.2Name or abbreviated title of the trial where available
    Fluoxetine Or Control Under Supervision (FOCUS)
    A.4.1Sponsor's protocol code numberFOCUS2012
    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 SponsorUniversity of Edinburgh
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Stroke Association
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Stroke Association
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name Oxactin Capsules 20mg
    D.2.1.1.2Name of the Marketing Authorisation holderGenus Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namefluoxetine 20mg. (trade name is Oxactin 20mg)
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Nasogastric use (Noncurrent)
    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 placeboOther use (Noncurrent)
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute stroke
    E.1.1.1Medical condition in easily understood language
    A stroke occurs when a blood vessel in the brain is either blocked suddenly or bursts. This results in a range of neurological effects such as a weak arm, a weak leg, or difficulty speaking.
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019016
    E.1.2Term Haemorrhagic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Is there a difference in the functional outcome, measured with the modified Rankin score, at 6 months between those treated with fluoxetine (20mg daily) for 6 months after stroke, and those treated with placebo?
    E.2.2Secondary objectives of the trial
    1. Is there a difference in the long term survival between those treated with fluoxetine versus placebo? 2. Is there a difference in the functional outcome, measured with the modified Rankin score at 12 months between those treated with fluoxetine versus placebo? 3. Is there a difference in motor function at 6 months and 12 months, between those treated with fluoxetine versus placebo? 4. Is there a difference in communication at 6 months and 12 months after stroke, between those treated with fluoxetine versus placebo? 5. Is there a difference in cognition, at 6 months and 12 months after stroke, between those patients treated with fluoxetine versus placebo? 6. Is there a difference in aspects of quality of life (mood, fatigue, participation) at 6 and 12 months between those treated with fluoxetine versus placebo? 7. Is there a difference in the cost of health and social care over at 6 months and 12 months between those treated with fluoxetine versus placebo?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. New acute stroke 2. Brain imaging is compatible with intracerebral haemorrhage or ischaemic stroke 3. Randomisation can be performed between 2 and 15 days after stroke onset 4. Stroke deficits limiting function at the time of randomisation
    E.4Principal exclusion criteria
    • <18 years old • Subarachnoid haemorrhage, although where this is secondary to an intracerebral haemorrhage the patient will be eligible • Unlikely to be available for follow-up e.g. no fixed home address. Unable to speak English unless they have a close friend or relative who can act as a translator/interpretor • Patient has other life threatening illness (e.g. advanced cancer) likely to lead to death within a few months. • Depression requiring pharmacological treatment with a Selective Serotonin Reuptake Inhibitor (SSRI) Drug. (i.e. the same class of drug as Fluoxetine) • Pregnant or breast-feeding woman, women of child bearing age not taking contraception • History of epileptic seizures • Allergy to, or contraindications to fluoxetine including: o Hepatic failure o Renal failure (eGFR < 30ml/min) o Taken a monoamine oxidase inhibitor in last 5 weeks Co- administration of Fluoxetine and a Mono Amine Oxidase Inhibitors (MAOI) may result in life threatening interactions. Therefore, patients on MAOI inhibitors are ineligible for the FOCUS trial. Also, any patient needing treatment with a MAOI must stop their trial treatment for at least 5 weeks before commencing the MAOI). We will allow co-enrollment to another CTIMP, providing we can attribute adverse events to each specific IMP.
    E.5 End points
    E.5.1Primary end point(s)
    Is there a difference in the modified Rankin score at 6 months following stroke between those treated with fluoxetine compared to placebo?
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    • Survival to one year and beyond • Euroquol 5D to provide overall assessment of the patients health related Quality of life. • MHI 5- the mental health inventory from the SF36 will provide a measure of depression and anxiety. This brief measure performs well, compared with longer questionnaires (e.g. MHI-18, GHQ-12, GHQ-30, in the detection of depression and anxiety (Berwick et la 1991, Mccabe et al 1996, Hoeymans at al 2004) • The vitality subscale of the SF36 will be used to assess patients level of fatigue • The Stroke Impact Scale will provide an overall assessment of patient outcome as well as allowing us to assess the effect of treatment on specific outcomes of importance to the patients. • New diagnosis of depression since randomisation requiring antidepressant medication • Hospitalisation days since enrolment. (obtained from GPs or if not randomising centre) • Days spent in care home since randomisation • Formal carers – total number of visits per week
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse effects will be reported at hospital discharge. All endpoints including adverse effects will be collected at 6 months after randomisation. All endpoints will be collected at 12 months after randomisation. Additionally, there will be a 24 hour helpline, a participant section of the trial website where advice on possible adverse events can be collated, and participants will be given a freepost envelope and card to return to us with details of any adverse reactions that they have experienced
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned125
    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. However, we will be seeking longer term outcome data through routine statistics
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days29
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2000
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    We will include adults unable to give consent for themselves. Minimum contraceptive advice is oral contraceptive pill.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3000
    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)
    The participants themselves will not receive the intervention after the trial ends. This is because the intervention period is only six months, so by the time they finish the trial, they would already have completed their course of fluoxetine. Should patients receive fluoxetine if the trial is stopped prematurely because fluoxetine is of benefit? If participants have already been allocated the fluoxetine, they should continue receive fluoxetine from their GP for a total duration of 6 months.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Stroke Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-16
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