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    Summary
    EudraCT Number:2010-022284-35
    Sponsor's Protocol Code Number:R00002CR301(ORF)
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-23
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-022284-35
    A.3Full title of the trial
    CLINICAL EFFICACY AND SAFETY OF
    TAZAROTENE CREAM 0.05% IN THE INITIAL
    AND MAINTENANCE THERAPIES OF LAMELLAR ICHTHYOSIS (LI)

    Last EMA Decision number of Paediatric Investigation Plan: P/0250/2012
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL EFFICACY AND SAFETY OF
    TAZAROTENE CREAM 0.05% IN THE INITIAL
    AND MAINTENANCE THERAPIES OF LAMELLAR ICHTHYOSIS (LI)
    A.4.1Sponsor's protocol code numberR00002CR301(ORF)
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/109/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOrfagen
    B.1.3.4CountryFrance
    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 supportOrfagen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrfagen
    B.5.2Functional name of contact pointInformation contact
    B.5.3 Address:
    B.5.3.1Street AddressCRDPF Langlade - Orfagen -3 avenue Hubert Curien - BP 13562
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.6E-mailinfo@orfagen.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 Yes
    D.2.1.1.1Trade name Tazorac
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Laboratories
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/06/423
    D.3 Description of the IMP
    D.3.1Product nameTazarotene
    D.3.2Product code R0002 CR 01A
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTAZAROTENE
    D.3.9.1CAS number 118292403
    D.3.9.3Other descriptive nameEthyl 6-[2-(4,4 dimethylthiochroman-6-yl)ethynyl]nicotinate
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameUrea 5%
    D.3.2Product code RV4341A
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 57-13-6
    D.3.9.3Other descriptive nameUREA
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 nameUrea 10%
    D.3.2Product code RV4200A
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 57-13-6
    D.3.9.3Other descriptive nameUREA
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lamellar Ichtyosis (LI)
    E.1.1.1Medical condition in easily understood language
    Lamellar Ichtyosis (LI)
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the long-term clinical efficacy and safety of Tazarotene 0.05% cream in LI patients in real-life setting conditions.
    E.2.2Secondary objectives of the trial
    The secondary objectives are :
    - To assess the durability of remission (relapse/prevention) under maintenance treatment.
    - To assess the relapse/rebound after the end of the maintenance treatment.
    - To evaluate benefit and life quality outcome of the patients.
    - To measure the systemic absorption of the active drug in LI patients in the real life condition of product use at the end of initial therapy and maintenance therapy.
    - To monitor laboratory values during normal conditions of product use.
    - To evaluate the overall acceptability of the product by the patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Male or female patients of at least 9 years old,
     [For Swedish center only] young girls over 15 years of age,
     [For Tunisian centers] patient over 18 years of age,
     Patients with a documented diagnosis of LI based on clinical signs, histopathology and/or genotype and, when possible, pedigree analysis,
     Patients requiring topical treatment by keratolytics either as monotherapy or as alternate therapy to oral retinoids,
     Patients with a global score of at least 3 for each parameter scaling and roughness, according to the scale used for primary efficacy parameter,
     Patients or patient’s parents/guardians able to understand and follow the study procedures,
     Written informed consent (personally signed and dated) from the patients and/or parent(s)/guardian(s) (according to local legislation),
     Patients or patients’ parents/guardians affiliated to a healthcare security system (when applicable in the national regulation).
    E.4Principal exclusion criteria
     Patients under 9 years of age,
     [For Swedish center only] young girls under 15 years of age,
     [For Tunisian centers] patient under 18 years of age,
     Pregnant or lactating women,
     Women of childbearing potential with no reliable medical contraception (oral contraceptive, intra-uterine contraceptive device), and unwilling to use condoms up to 8 weeks after the last test product application,
     [For german centers only] Young girls (9-17 years old) who are already of child bearing potential but not already taking a medical contraception (oral contraceptive, intra uterine contraceptive device) beforehand to the clinical trial, and unwilling to use condoms up to 8 weeks after the last test product application,
     Women of childbearing potential with a positive systemic pregnancy test at baseline,
     Patients with congenital ichthyoses other than LI,
     Patients with an erythrodermic component of LI (EARLI),
     Patients with LI of overall severity < 3 for scaling or roughness, according to the scale used for primary efficacy parameter,
     Patients with lesional superinfection,
     Patients with skin or other disease likely to interfere with the study conduct or the evaluation parameters,
     Patients with excessive pruritus, burning, skin redness or peeling, not fully recovered at baseline,
     Patients with inherent sensitivity to sunlight,
     Patients with a known contact allergy to one of the ingredients contained in the test products,
     Patients treated with topicals (e.g. vitamin A analogues, vitamin D analogues) within 14 days prior to baseline,
     Patients treated with tazarotene gel within 28 days prior to baseline,
     Patients treated with keratolytics (e.g. urea, hydroxy-acids) or moisturizers other than the standard moisturizer within 7 days prior to baseline,
     Patients treated with concomitant dermatologic medications and cosmetics that have a strong drying effect within 7 days prior to baseline,
     Patients treated with oral retinoids during the preceding 28 days, or with oral vitamin A supplementation (more than 3000 IU per day) during the preceding 7 days of baseline,
     Patients treated with drugs known to be photosensitizers (e.g. oral and topical antiinflammatories, thiazides, tetracyclines, quinolones, phenothiazines, sulfonamides, hydrochlorates, chlorpromazine, psoralen, amiodarone, tar) within 14 days prior to baseline,
     Patients with a medical condition that potentially alters bone metabolism (e.g. osteoporosis, thyroid dysfuntion, Cushing syndrome) or treated with a medication interfering with bone activity (e.g. corticosteroids, thyroid hormones, vitamin D analogues, cytotoxics, biphospbonates, calcitonins, tetracyclines, quinolones, thiazides, salicylates in long-term course, heparin, theophylline, barbiturates, colchicines) within the preceding 56 days prior to baseline,
     Patients treated with UV therapy or patients medically exposed to UV within 28 days prior to baseline,
     Patients having significant sun exposure due to their occupation,
     Patients who participated in a study within the 3 months prior to study entry,
     Patients or patients’ parents/guardians who are unable to understand and/or to follow the study procedures and patient instructions,
     Patients or patients’ parents/guardians who are unwilling to give personally signed and dated written informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    Response to test treatment at the end of initial therapy (Day 84)

    At each study visit, the overall severity of scaling (visual assessment) and roughness (palpation) will be evaluated by an independent physician not involved in the management of the patients (masked assessment), according to the following 5-point Physician General Assessment (PGA) scale:
    0 = Normal skin all over the treated BSA
    1 = Lesions of slight intensity involving < 30% of the treated BSA
    2 = Lesions of slight intensity involving > 30% of the treated BSA
    3 = Lesions of moderate intensity involving > 30% of the treated BSA
    4 = Lesions of severe intensity involving > 30% of the treated BSA
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 84
    E.5.2Secondary end point(s)
     Time-course severity of scaling, roughness and erythema on the treated areas, according to the scale used in the primary efficacy parameter for scaling and roughness and to a 4-point severity scale for erythema (0 = normal skin color, 1 = barely detectable pink color, 2 = definite red hue, 3 = intense red color) at Baseline, Days 28, 56, 84, 126, 168, 196, and 224 visits, by the independent physician.
     Assessment of the relapse/rebound of the treated areas, according to the scale defined in the primary efficacy parameter, during Period II and Period III. A relapse will be defined as a severity score of at least 3 for scaling or roughness. A rebound will be defined as a score over the baseline score on scaling or roughness.
     Separate assessment of the overall clinical severity of the lesions on palms and soles at Baseline, Days 28, 56, 84, 126, 168, 196 and 224 visits, according to a 4-point severity scale (0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe), by the independent physician.
     Autoevaluation of the overall severity of the lesions by the patients, at all study visits from Baseline. Autoevaluation tools will be a 10-cm visual analogue scale filled in by the patients themselves for adults and children of at least 12 years of age, and by the parents for children below 12 years of age.
     Life quality assessment by the patients, using the generic Short-Form 12 questionnaire (SF-12) for patients from 16 years of age and the Dermatologic Life Quality Index (DLQI) for patients over 16 years of age (i.e. from 17 years of age), or the child DLQI (CDLQI) for patients between 9 years and 16 years old, at Baseline, Day 84 (end of Period I) and Day 168 (end of Period II).
     Global local tolerance made on Day 84 (end of Period I) and Day 168 (end of Period II), according to the following 4-point scale,
    1 = Very good tolerance: no subjective or physical sign of local side effects.
    2 = Good tolerance: transitory subjective signs, without physical sign nor necessary modification of the frequency of test product application.
    3 = Poor tolerance : persisting subjective signs or physical signs of local side effects, leading to modification of the frequency of the test product application but no treatment discontinuation.
    4 = Very poor tolerance: subjective and/or physical signs leading to treatment discontinuation.
     Overall acceptability by the patients (efficacy, local tolerance, ease of use) on Day 84 (end of Period I) and end of Period II (Day 168). Patients (or parents for children < 12 years old) will be asked to quote each acceptability parameter according to the 4-point scale that follows:
    0 = Not satisfactory at all
    1 = Poorly satisfactory
    2 = Satisfactory
    3 = Very satisfactory
     Plasma monitoring of Tazarotenic acid at baseline, Day 84 (end of Period I),Day 168 (end of Period II), Day 224 (end of period III). Additional measurement will be performed 6 months and 12 months after study end in the paediatric population, through an observational period providing that the value at study end will be measured above the limit of quantification.
     Blood laboratory tests (hematology, chemistry, liver activity markers, serum lipids) at Baseline, Day 84 (end of Period I), Day 168 (end of Period II), and Day 224 (end of period III), Clinically significant abnormal values will be recorded as adverse event and followed-up. Additional measurement will be performed 6 months and 12 months after study end in the paediatric population, through an observational period.
     Measurement of bone metabolism, using plasmatic biochemical markers (osteocalcin, CTX, PTH, calcemia, alcalin phosphatase, phosphoremia, 25-OH Vitamin D) at Baseline, Day 84 (end of Period I), Day 168 (end of Period II), and Day 224 (end of period III). Additional measurement will be performed 6 months and 12 months after study end in the paediatric population, through an observational period.
     Physical examination at each visit.
     Adverse events. An independent Data Safety Management Board (DSMB) will be set up to review adverse events during the study and take any decision in the interest of the patient safety.
     Compliance (records of application frequency, returned tubes weighing).

    Period IV: All the parameters assessed at the D168 visit of the initial study will be collected at 3-monthly intervals.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above
    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 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 Yes
    E.8.1.7.1Other trial design description
    1 year children follow up and study extension open labelled (Period IV)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Urea 10% for adult or 5% for children
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Algeria
    Tunisia
    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
    End of the initial study: date of the last visit of the last patient of the Period II or Period III. End of the children follow-up: date of the last visit of the last child undergoing the follow-up.
    End of the Study extension/Period IV: date of the last visit of the last patient undergoing the study extension.
    End of total study: last visit of the last patient (whatever the study period)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 31
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 21
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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
    Minors will be included. Persons of this age group are generally incapable of giving consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    Treatment according to usual pratices of physicians.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-03
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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