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    Summary
    EudraCT Number:2011-003775-11
    Sponsor's Protocol Code Number:
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-09-07
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-003775-11
    A.3Full title of the trial
    Fluoxetine therapy for multiple sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fluoxetine therapy for multiple sclerosis
    A.3.2Name or abbreviated title of the trial where available
    FLUOX-PMS
    A.4.1Sponsor's protocol code number
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Fluoxetine
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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
    D.3.2Product code fluoxetine
    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 INNFluoxetine
    D.3.9.1CAS number 59333-67-4
    D.3.9.3Other descriptive name N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20 to 40
    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
    progressive multiple sclerosis
    E.1.1.1Medical condition in easily understood language
    a progressive phase of multiple sclerosis (demyelinating disease)
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10053395
    E.1.2Term Progressive multiple sclerosis
    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
    •at least a 20 % increase in the timed 25-Foot Walk (T25FW),
    or
    •at least a 20 % increase in the 9-Hole Peg Test (9-HPT) = assessment
    of upper limb function
    E.2.2Secondary objectives of the trial
    - Changes in global brain atrophy and diffusion tensor imaging.
    - T2 lesion load.
    - Proportion of patients without 20 % increase in the T25FW, or 20 %
    increase in the 9-HPT between weeks 12 and 108.
    - Significant difference in cognitive function measured by MACFIMS.
    Optional in some centers (UZ Brussel):
    •Changes in retinal nerve fiber layer thickness measured by optical
    coherence tomography between weeks 12 and 108.
    •Changes in NAA/Cr ratio and glutamate levels in white and gray matter
    between weeks 12 and 108.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent.
    2. Either secondary or primary progressive MS.
    3. Age 25-65 years.
    4. EDSS at baseline of 3 – 6.5 points inclusive.
    5. Disability increased in the preceding year because of steady disease progression.
    6. Ability to be compliant with the schedule of protocol assessments.
    7. For sexually active female patients with reproductive potential, use of reliable means of contraception.
    E.4Principal exclusion criteria
    1.Pregnancy or lactation
    2.Allergy to fluoxetine
    3.Use of fluoxetine
    4.Use of other antidepressants, unless they can be stopped for 2 months before starting with the study medication.
    5.Contraindication for MRI (relative exclusion criterion because patients who have a contraindication are allowed to participate).
    6.Major depression following the DSM-IV
    7.Other neurologic, serious psychiatric or systemic disorders that could interfere with the assessments.
    8.Use of immunomodulatory or immunosuppressive drugs, except for interferon’s 1a and 1 b or glatiramer (as it has been shown hat these are ineffective in slowing down progression). Patients using other immune drugs can be included if these treatments are stopped before randomization.
    9.Participation in another clinical trial
    10.Concomitant use of drugs that can cause a serotonin syndrome unless they can be stopped before randomization.
    E.5 End points
    E.5.1Primary end point(s)
    Time to confirmed disease progression, defined as either
    • sustained EDSS increase of 1 point from baseline EDSS if the baseline EDSS was between 3.0 and 5.5 points, or an EDSS increase of 0.5 point if the baseline EDSS was ≥ 5.5 points,
    or
    • at least a 20 % increase in the timed 25-Foot Walk (T25FW),
    or
    • at least a 20 % increase in the 9-Hole Peg Test (9-HPT) = assessment of upper limb function

    in each situation the change cannot be attributed to another etiology (e.g. fever, concurrent illness, injury, adverse reactions to concurrent medications, or relapse), and is sustained for ≥ 12 weeks (as assessed during the next visit and at the end of the study).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 3 months
    E.5.2Secondary end point(s)
    - Changes in global brain atrophy and diffusion tensor imaging.
    - T2 lesion load.
    - Proportion of patients without 20 % increase in the T25FW, or 20 % increase in the 9-HPT between weeks 12 and 108.
    - Significant difference in cognitive function measured by MACFIMS. (Modified fatigue Impact Scale (MFIS), Beck depression inventory-II (BDI-II) will also be done to control for influences of depression or fatigue on testing)

    Optional in some centers:
    - Changes in retinal nerve fiber layer thickness measured by optical
    coherence tomography between weeks 12 and 108.
    - Changes in NAA/Cr ratio and glutamate levels in white and gray matter between weeks 12 and 108.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - MRI: weeks 12 and 108
    - Proportion of patients without 20 % increase in the T25FW, or 20 %
    increase in the 9-HPT between weeks 12 and 108.
    - Significant difference in cognitive function between week 0, 60 and
    week 108.
    Optional in some centers (UZ Brussel):
    •Changes in retinal nerve fiber layer thickness measured by optical
    coherence tomography between weeks 12 and 108.
    •Changes in NAA/Cr ratio and glutamate levels in white and gray matter
    between weeks 12 and 108.
    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 No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 No
    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 years4
    E.8.9.1In the Member State concerned months
    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: 120
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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
    G.4.1Name of Organisation AZ Sint Jan Brugge
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Elisabeth ziekenhuis
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation UZ Gent
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Stedelijk Ziekenhuis Aalst
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation OLV Aalst
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation H.-Hartziekenhuis Menen
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation AZ Damiaan Oostende
    G.4 Investigator Network to be involved in the Trial: 8
    G.4.1Name of Organisation Kortrijk AZ Groeninge
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 9
    G.4.1Name of Organisation Az Maria Middelares Gent
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 10
    G.4.1Name of Organisation MS centrum Melsbroek
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 11
    G.4.1Name of Organisation Sint Maria Ziekenhuis Halle
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 12
    G.4.1Name of Organisation UZ Antwerpen / Mick
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 13
    G.4.1Name of Organisation MS centrum Overpelt
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 14
    G.4.1Name of Organisation AZ Sint-Jozef Turnhout
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 15
    G.4.1Name of Organisation Virga Jesse Ziekenhuis Hasselt
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 16
    G.4.1Name of Organisation Rijnstate Ziekenhuis
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 17
    G.4.1Name of Organisation Universitair Medisch Centrum Groningen
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 18
    G.4.1Name of Organisation Orbis Medisch centrum Sittard/ academisch MS centrum Limburg
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 19
    G.4.1Name of Organisation Canisius Wilhelmina Ziekenhuis Nijmegen
    G.4 Investigator Network to be involved in the Trial: 20
    G.4.1Name of Organisation Catharina Ziekenhuis
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
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