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    Summary
    EudraCT Number:2013-003241-42
    Sponsor's Protocol Code Number:ALA-BCC-CT008
    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:2014-02-03
    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 number2013-003241-42
    A.3Full title of the trial
    A randomized, observer blind, multinational phase III study to evaluate the safety and efficacy of BF-200 ALA (Ameluz®) in comparison to Metvix® in the treatment of non-aggressive basal cell carcinoma (BCC) with photodynamic therapy (PDT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the effective and safe use of the drug product in the treatment of basal cell carcinoma
    A.3.2Name or abbreviated title of the trial where available
    ALA-BCC-CT008
    A.4.1Sponsor's protocol code numberALA-BCC-CT008
    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 SponsorBiofrontera Bioscience GmbH
    B.1.3.4CountryGermany
    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 supportBiofrontera Bioscience GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiofrontera Bioscience GmbH
    B.5.2Functional name of contact pointDrug Development Department
    B.5.3 Address:
    B.5.3.1Street AddressHemmelrather Weg 201
    B.5.3.2Town/ cityLeverkusen
    B.5.3.3Post code51377
    B.5.3.4CountryGermany
    B.5.4Telephone number+492148763226
    B.5.5Fax number+492148763290
    B.5.6E-mailameluz@biofrontera.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 Ameluz(R)
    D.2.1.1.2Name of the Marketing Authorisation holderBiofrontera Bioscience GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN5-Aminolaevulinic acid
    D.3.9.1CAS number 5451-09-2
    D.3.9.3Other descriptive nameAMINOLEVULINIC ACID HYDROCHLORIDE
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number78
    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 Yes
    D.2.1.1.1Trade name Metvix(R)
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma (UK) Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmethyl aminolevulinate
    D.3.9.1CAS number 79416-27-6
    D.3.9.3Other descriptive nameMETHYL AMINOLEVULINATE HYDROCHLORIDE
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Basal cell carcinoma (BCC)
    E.1.1.1Medical condition in easily understood language
    Rodent ulcer - small, fair papules, flesh-colored, round or oval translucent nodule, or scaly, localized plaque in frequently sun-exposed skin
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10004146
    E.1.2Term Basal cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare the efficacy of BF-200 ALA containing 7.8% 5-aminolevulinic acid (ALA) as active ingredient with the comparator Metvix®, containing 16% methyl-aminolevulinate in the treatment of thin, non-aggressive BCC with photodynamic therapy. Clinical efficacy and safety of BF-200 ALA in PDT were proven for the treatment of mild and moderate AK in 1 dose-finding and 2 confirmatory studies encompassing a total of 798 enrolled patients comprising 357 patients (2,114 lesions) exposed to BF-200 ALA.
    A phase II study in BCC using a preliminary 10% 5-ALA nanoemulsion formulation showed a promising complete lesion response rate in superficial basal cell carcinoma (sBCC) of 85% 6 months after a single PDT. In the study, BCC lesions were located in different body regions.
    For the treatment of non-aggressive BCC, side effects are expected to be similar to those observed in the PDT of AK, mainly self-limiting pain and erythema at the application site. Based
    E.2.2Secondary objectives of the trial
    • Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT,
    • Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT,
    • Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2,
    • The overall cosmetic outcome 12 weeks after the last PDT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Willing and able to sign the informed consent form. A study-specific informed consent must be obtained in writing for all patients before any study procedures.
    • Men or women ≥18 years of age (inclusive).
    • Presence of 1 to 3 thin (≤2 mm thickness), non-aggressive, primary BCC lesions (comprising primary superficial, nodular, or mixed superficial/nodular) in the face/forehead outside the H-zone (see Appendix B), bald scalp, extremities and/or neck/trunk. Confirmation of non-aggressiveness and thickness of BCC through biopsies of all lesions taken at screening.
    To document and confirm the investigator’s clinical diagnosis of non-aggressive behavior of the lesions:
    Pre-study biopsies must be taken from all BCC lesions at the screening visit (Visit 1). Investigators are requested to take the 3 mm biopsy at the region of the tumor which, according to clinical judgment, appears thickest.
    - The biopsy material will be histopathologically evaluated by a dermatopathological expert according to the WHO classification/subtyping(2). In case no clear histopathological assessment can be performed a second biopsy may be taken after approval of the sponsor. Hence, the time interval between Visit 1 and Visit 2 has to be expanded accordingly.
    The result of the biopsies will ultimately determine whether the patient is eligible for the study; the patient may only be enrolled if the investigator’s clinical diagnosis of non-aggressive BCC is confirmed for all lesions by the histopathological evaluation according to WHO classification guideline(2) and the lesion thickness is ≤2 mm.
    • The diameter of each lesion should range between ≥0.5 cm and ≤2 cm; the total maximal treated area must be not larger than approximately 10 cm² (including a 0.5 – 1.0 cm margin surrounding each lesion). The maximal thickness of a lesion should not exceed 2 mm (by means of histopathological confirmation).
    The size of each baseline BCC lesion is determined by measuring the two largest perpendicular diameters. To describe irregular lesions (ellipsoidal), investigators must measure the major and minor axes, which must both be within the acceptable limits defined above.
    • Target BCC lesions must be discrete and quantifiable and have to be located within 1 to 2 treatment areas.
    • Willingness to undergo biopsy at the end-of-study visit 12 weeks after the last PDT in case of partial or non-responding lesions.
    • Willingness to receive up to 4 PDTs within 3.5 months.
    • Free of significant physical abnormalities (eg tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation.
    • Willingness to stop the use of moisturizers and any other topical treatments within the treatment area (during the observer blind part of the study), including anti-aging products, vitamin A-, vitamin D-, and/or vitamin E-containing ointments and creams, and green tea preparations during the study. Sunscreens will be allowed, but should not be applied in the treatment area within approximately 24 h before a clinical visit that involves a lesion count.
    • Accept to abstain from extensive sunbathing and use of a solarium during the observer blind part of the study. Patients with sunburn within the treatment areas cannot be included until fully recovered.
    • Healthy patients or patients with clinically stable medical conditions as confirmed by physical examination and by medical history, including but not limited to controlled hypertension, diabetes mellitus type II, hypercholesterolemia, and osteoarthritis, will be permitted to be included in the study if their medication is not prohibited by this protocol.
    • Women of childbearing potential are permitted to participate in this study only if they have a negative serum pregnancy test at screening and a willingness to use a highly effective method of contraception during the observer blind part of the study. A woman is considered to be of childbearing potential if she possesses a uterus and at least one ovary, has not had a tubal ligation, or is not postmenopausal for at least 3 years. Highly effective methods of birth control are defined as resulting in a low failure rate (Pearl Index below 1, failure rate less than 1% per year) when properly used. This includes methods such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or sexual intercourse with a vasectomized partner. The use of condoms without spermicide coating is not considered to be a highly effective method of contraception.
    E.4Principal exclusion criteria
    • History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA.
    • History of hypersensitivity to MAL or any ingredient of Metvix® cream including arachis oil, or to peanut or soya.
    • Current treatment with immunosuppression therapy.
    • Presence of porphyria.
    • Hypersensitivity to porphyrins.
    • Presence of BCC lesions on embryonic fusion planes (H-zone, see Appendix B).
    • Presence of more than 3 BCCs.
    • Presence of malignant or benign tumors or precancerous lesions of the skin other than non-aggressive BCC within the treatment area (eg malignant melanoma, squamous cell carcinoma (SCC)) within the last 12 weeks.
    • Gorlin Syndrome or Xeroderma pigmentosum.
    • Presence of photodermatoses.
    • Confirmed histopathological diagnosis of other than non-aggressive BCC.
    • Treatment of recurrent BCCs, pigmented or aggressive BCCs including morpheiform BCC.
    • Treatment of lesions (AK, BCC, SCC, Bowens disease, melanoma) ≤12 weeks prior to first PDT, except physical treatments (eg cryosurgery, excision surgery) that will not be allowed ≤4 weeks prior to screening visit (Visit 1).
    • Presence of inherited or acquired coagulation defect.
    • Start of intake of medication with hypericin or systemically-acting drugs with phototoxic or photoallergic potential, such as psoralenes, tetracyclines, nalidixic acid, furosemide, amiodarone, phenothiacines, chinolones, fibrates, or phytotherapy with St. John’s wort, arnica, or valerian, or topically applied phototoxic substances like tar, pitch, psoralenes or some dyes like thiazide, methylene blue, toluidine blue, eosine, Bengal rose, or Acridine within 8 weeks prior to screening. Patients may, however, be enrolled if such medication was taken for more than 8 weeks prior to screening without evidence of a phototoxic/photoallergic reaction. Within 8 weeks prior to screening and during the observer-blind part of the study, such medication must not be newly prescribed. Should such a prescription become unavoidable for medical reasons during the clinical part of the trial, the investigator has to consult with the sponsor, who may discontinue the patient’s study participation, if deemed necessary.
    • Clinically relevant cardiovascular, hepatic, renal, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult.
    • Evidence of clinically significant (CS), unstable medical conditions, such as:
    - Metastatic tumor or tumor with high probability of metastatic spread.
    - Cardiovascular disease (New York Heart Association (NYHA) class III, IV).
    - Immunosuppressive condition.
    - Hematologic, hepatic, renal, neurologic, or endocrine condition.
    - Collagen-vascular condition.
    - Gastrointestinal condition.
    • Topical treatment with 5-ALA or MAL outside the treatment area during the observer blind part of the study.
    • Any topical treatment including diclofenac and immunomodulatory agents (eg imiquimod, ingenol mebutate) 12 weeks prior to the first PDT session and during the observer blind part of the study.
    • Any physical treatment during the observer blind part of the study within the treated target areas.
    • None of the following systemic treatments within the designated period prior to the first PDT session and during the observer blind part of the study:
    - Interferon (6 weeks)
    - Immunomodulators or immunosuppressive therapies (10 weeks)
    - Cytotoxic drugs (6 months)
    - Investigational drugs (8 weeks)
    - Drugs known to have major organ toxicity (8 weeks)
    - Corticosteroids (oral or injectable) (6 weeks)
    - Inhaled corticosteroids (>1200 µg/day for beclomethasone, or >600 µg/day for fluticasone) (4 weeks)
    - MAL or 5-ALA (12 weeks)
    • Pregnancy.
    • Breast feeding.
    • Patients with any dermatological disease in the treatment region or surrounding region that may be exacerbated by treatment with topical 5-ALA or MAL or that may cause difficulty with examinations (eg psoriasis, eczema).
    • Patients showing cornu cutaneum-like alterations of the skin in the face or on the bald scalp (ie target region).
    • Participation in a clinical study within 2 months prior to screening.
    • Drug or alcohol abuse in the preceding 2 years.
    • Patient is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.
    • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
    • Patient is unlikely to comply with protocol, eg uncooperative attitude, inability to return for FU visits, and unlikelihood of completing the study.
    • Confirmed diagnosis of human immunodeficiency virus (HIV)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the overall patient complete response assessed clinically 12 weeks after the last PDT. An overall complete responder is defined as a patient in whom all treated lesions were cleared 12 weeks after the last PDT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    See definition in sec. E.5.1
    E.5.2Secondary end point(s)
    • Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT,
    • Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT,
    • Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2,
    • The overall cosmetic outcome 12 weeks after the last PDT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See definition in sec. E.5.2
    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 No
    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
    observer blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    The end of the study is defined as the date of the last FU visit of the last patient.
    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 months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days1
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 360
    F.4.2.2In the whole clinical trial 360
    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)
    All patients whose BCC lesions did not completely clear 12 weeks after the last PDT will receive a conventional treatment of their remaining BCC at the discretion of the investigator within the study.
    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 Decision2014-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-17
    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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