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    Summary
    EudraCT Number:2015-004798-34
    Sponsor's Protocol Code Number:ATB200-02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-01-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-004798-34
    A.3Full title of the trial
    AN OPEN-LABEL, FIXED-SEQUENCE, ASCENDING-DOSE, FIRST-IN-HUMAN STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF INTRAVENOUS INFUSIONS OF ATB200 CO-ADMINISTERED WITH ORAL AT2221 IN ADULT SUBJECTS WITH POMPE DISEASE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is an open-label, fixed-sequence, ascending-dose, first-in-human study to evaluate the safety, tolerability, PK, PD and efficacy of intravenous (IV) ATB200 when co-administered with oral AT2221.
    A.4.1Sponsor's protocol code numberATB200-02
    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 SponsorAmicus Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportAmicus Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmicus Therapeutics, Inc.
    B.5.2Functional name of contact pointJacquelyn Wright
    B.5.3 Address:
    B.5.3.1Street Address1 Cedar Brook Drive
    B.5.3.2Town/ cityCranbury
    B.5.3.3Post codeNJ 08512
    B.5.3.4CountryUnited States
    B.5.4Telephone number16096622000
    B.5.6E-mailjwright@amicusrx.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2000
    D.3 Description of the IMP
    D.3.1Product nameATB200
    D.3.2Product code ATB200
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcipaglucosidase alfa
    D.3.9.1CAS number 420784-05-0
    D.3.9.2Current sponsor codeATB200
    D.3.9.4EV Substance CodeSUB21275
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2129
    D.3 Description of the IMP
    D.3.2Product code AT2221
    D.3.4Pharmaceutical form Capsule, hard
    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 INNMIGLUSTAT
    D.3.9.1CAS number 72599-27-0
    D.3.9.2Current sponsor codeAT2221
    D.3.9.4EV Substance CodeSUB20049
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number65
    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
    Pompe Disease - acid maltase deficiency or glycogen storage disease type II.
    E.1.1.1Medical condition in easily understood language
    Pompe Disease
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036143
    E.1.2Term Pompe's disease
    E.1.2System Organ Class 100000004850
    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 and tolerability of single-ascending doses of intravenously (IV) infused ATB200.

    To evaluate the safety and tolerability of single-ascending doses of IV infused ATB200 as a fixed dose, co-administered with ascending oral doses of AT2221.

    To characterize the pharmacokinetics (PK) of single-ascending doses of IV infused ATB200.

    To characterize the single- and multiple-dose PK of IV infused 20 mg/kg ATB200 when co-administered with oral 130 mg or 260 mg AT2221.

    To characterize the PK of single- and multiple-oral doses of 130 mg or 260 mg AT2221 when co-administered with IV infused ATB200.
    E.2.2Secondary objectives of the trial
    Evaluate long-term efficacy of 20mg/kg IV infused ATB200 as a fixed dose co-administered with oral 260mg AT2221 in all subjects from Stage 3
    Evaluate the long-term safety & tolerability of 20 mg/kg of IV infused ATB200 as a fixed dose co-administered with oral 260mg AT2221 in all subjects from Stage 3
    Characterize single & multiple dose PK of plasma rhGAA activity and total rhGAA protein following IV infused 20mg/kg ATB200 as a fixed dose co-administered with oral 260mg AT2221 in ERT-naïve subjects
    Characterize the single & multiple-dose PK of plasma AT2221 following 20mg/kg of IV infused ATB200 co-administered with oral 260 mg AT2221 in ERT-naïve subjects

    Exploratory:
    Anti-rhGAA antibody titersantibodies (total and neutralizing)
    Cross-reactivity of anti-rhGAA antibodies to alglucosidase alfa
    Pro-inflammatory cytokines and other biomarkers of immune system activation
    PD markers
    Impact of anti-rhGAA antibodies on plasma GAA total protein exposures
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cohort 1:
    1. Male and female subjects between 18 and 65 years of age, inclusive.
    2. Subject must provide signed informed consent prior to any study-related procedures.
    3. Subjects of childbearing potential must agree to use medically accepted methods of contraception during the study and for 90 days after last co-administration of ATB200 and AT2221.
    4. Subject has a diagnosis of Pompe disease based on documented deficiency of GAA enzyme activity or by GAA genotyping.
    5. Subject has received ERT with alglucosidase alfa (myozyme/lumizyme) for the previous 2 to 6 years inclusive.
    6. Subject is currently receiving alglucosidase alfa (myozyme/lumizyme) at a frequency of once every other week.
    7. Subject has received and completed the last two infusions without a drug-related adverse event resulting in dose interruption.
    8. Subject must be able to walk 200 and 500 meters on the 6MWT.
    9. Upright FVC must be 30% to 80% of predicted normal value.

    Cohort 2:
    10. Male and female subjects between 18 and 65 years of age, inclusive.
    11. Subject must provide signed informed consent prior to any study-related procedures.
    12. Subjects of childbearing potential must agree to use medically accepted methods of contraception during the study and for 90 days after last co-administration of ATB200 and AT2221.
    13. Subject has a diagnosis of Pompe disease based on documented deficiency of GAA enzyme activity or by GAA genotyping.
    14. Subject has received ERT with alglucosidase alfa (myozyme/lumizyme) for ≥2 years.
    15. Subject is currently receiving alglucosidase alfa (myozyme/lumizyme) at a regular or set frequency.
    16. Subject has received and completed the last two infusions without a drug-related adverse event resulting in dose interruption.
    17. Subject must be completely wheelchair-bound and unable to walk unassisted.

    Cohort 3:
    18. Male and female subjects between 18 and 65 years of age, inclusive.
    19. Subject must provide signed informed consent prior to any study related procedures.
    20. Subjects of childbearing potential must agree to use medically accepted methods of contraception during the study and for 90 days after last coadministration of ATB200 and AT2221.
    21. Subject has a diagnosis of Pompe disease based on documented deficiency of GAA enzyme activity or by GAA genotyping.
    22. Subject must be able to walk between 200 to 500 meters on the 6MWT.
    23. Upright FVC must be 30% to 80% of predicted normal value.

    Cohort 4:
    24.Male and female subjects between 18 and 75 years of age, inclusive
    25.Subject must provide signed informed consent prior to any study related procedures
    26.Subject has documented 6MWT on three separate occasions, each at least six months apart with at least two values in the past three years
    27.Subjects of childbearing potential must agree to use medically accepted methods of contraception during the study and for 90 days after last co-administration of ATB200 and AT2221
    28. Subject has a diagnosis of Pompe disease based on documented deficiency of GAA enzyme activity or by GAA genotyping
    29. Subject has received ERT for the previous ≥ 7 years
    30. Subject is currently receiving alglucosidase alfa (Myozyme/Lumizyme) at a frequency of once every other week
    31. Subject has received and completed the last 2 infusions without a drug-related AE resulting in dose interruption
    32. Subject must be able to walk between 75 and 600 meters on the 6MWT
    33. Upright FVC must be 30% to 85% of predicted normal value
    E.4Principal exclusion criteria
    Cohort 1, 2, 3, 4:
    - Subject has received treatment with prohibited medications within 30 days or 5 half lives of the therapy treatment, whichever is longer prior to the Baseline Visit.
    - Subject, if female, is pregnant or breastfeeding at screening.
    - Subject, whether male or female, is planning to conceive a child during the study.
    - Subject has a medical or any other extenuating condition or
    circumstance that may, in the opinion of the investigator or the medical monitor, pose an undue safety risk to the subject or compromise his/her ability to comply with protocol requirements.
    - Subject has a history of allergy or sensitivity to miglustat or other iminosugars.
    - Subject with active bronchial asthma. All subjects with autoimmune disease must be discussed with the Amicus Medical Monitor
    - Subject with active systemic autoimmune disease such as lupus, scleroderma, or rheumatoid arthritis. All subjects with autoimmune disease must be discussed with the Amicus Medical Monitor

    Cohort 1:
    - Subject requires invasive ventilatory support.
    - Subject uses noninvasive ventilatory support ≥6 hours a day while awake.
    - Subject has a history of anaphylaxis to alglucosidase alfa.
    - Subject has a history of high sustained anti-rhGAA antibodies.
    -Subject has received any investigational therapy including adjunctive therapy for Pompe disease, other than alglucosidase alfa within 30 days prior to the Baseline Visit, or anticipates doing so during the study.

    Cohort 2:
    - Subject has a history of anaphylaxis to alglucosidase alfa.
    - Subject has a history of high sustained anti-rhGAA antibodies.
    - Subject has received any investigational therapy including adjunctive therapy for Pompe disease, other than alglucosidase alfa within 30 days prior to the Baseline Visit, or anticipates doing so during the study.

    Cohort 3
    - Subject has received any enzyme replacement therapy, including
    alglucosidase alfa at any time, or any investigational therapy for Pompe
    disease within 30 days prior to the Baseline Visit, or anticipates doing so
    during the study.
    - Subject requires invasive ventilatory support.
    - Subject uses noninvasive ventilatory support ≥6 hours a day while awake.

    Cohort 4
    - Subject requires invasive ventilatory support
    - Subject uses noninvasive ventilatory support ≥ 6 hours a day while awake
    - Subject has a history of anaphylaxis to alglucosidase alfa
    - Subject has a history of high sustained anti-rhGAA antibodies
    - Subject has received any investigational therapy including adjunctive therapy for Pompe disease, other than alglucosidase alfa within 30 days prior to the Baseline Visit, or anticipates doing so during the study.
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    Identification and counts of treatment-emergent SAEs, including IARs
    Changes from baseline in 12-lead ECG
    Changes from baseline in clinical safety laboratory evaluations: serum chemistry, hematology, and urinalysis
    Changes in PEs
    Changes from baseline in vital signs
    Changes from baseline in serum CK

    PK for subjects from Cohort 1:
    Plasma GAA activity levels and total GAA protein concentration PK parameters: Cmax, tmax, AUC0-t, AUC0-∞, t½, Vss and CLT for each dose level

    Stage 1: Ratios of plasma GAA activity and total GAA protein Cmax, AUC0-t, and AUC0-∞ for 20 mg/kg versus 5 mg/kg, 20 mg/kg versus 10 mg/kg, and 10 mg/kg versus 5 mg/kg

    Stage 2: Ratios of plasma GAA activity and total GAA protein Cmax, AUC0-t, and AUC0-∞ for 20 mg/kg ATB200 (from Stage 1) versus single-dose 20 mg/kg ATB200 + 130 mg AT2221, and versus single-dose 20 mg/kg ATB200 + 260 mg AT2221

    Stage 2: Ratios of plasma GAA activity and total GAA protein Cmax, AUC0-t, and AUC0-∞ for 20 mg/kg ATB200 + 130 mg AT2221 single-dose versus multiple-dose, and 20 mg/kg ATB200 + 260 mg AT2221 single-dose versus multiple-dose

    Plasma AT2221 PK parameters: Cmax, tmax, AUC0-t, AUC0-∞, t½, CLT/F, and Vz/F for each dose level

    Ratios of plasma AT2221 Cmax, AUC0-t, and AUC0-∞ for 260 mg single-dose versus 130 mg single-dose, and for 260 mg multiple-dose versus 130 mg multiple-dose
    E.5.1.1Timepoint(s) of evaluation of this end point
    Exploratory Endpoints:

    - Anti-rhGAA antibody titers (total and neutralizing).

    - Cross-reactivity of anti-rhGAA antibodies to alglucosidase alfa.

    - Pro-inflammatory cytokines and other biomarkers of immune system activation.

    - PD biomarkers: urinary Hex4 and serum CPK levels.

    - Evaluation of anti-rhGAA antibody impact on AUC and CLT after at least 18 months of ATB200/AT2221 treatment as compared to AUC and CLT after the first and third doses of 20 mg/kg ATB200 + 260 mg AT2221
    E.5.2Secondary end point(s)
    Functional:
    • For ambulatory subjects: change and percent change from Baseline to 6-month assessment in Gower's Maneuver, 4-stair-climb, 6MWT, 10MWT, GSGC score, TUG, muscle strength tests (MRC and hand-held dynamometer [for both upper and lower limbs]), and pulmonary function tests (FVC, MIP, MEP, and SNIP [for subjects without invasive ventilatory support]).
    • For nonambulatory subjects: change and percent change from Baseline to 6 month assessment in muscle strength tests (MRC and hand-held dynamometer [upper limbs only]) and pulmonary function tests (FVC,
    MIP, MEP, and SNIP [for subjects without invasive ventilatory support])

    Patient-Reported Outcomes:
    • Change and percent change from Baseline to 6 months in FSS, RHS, and R-PAct Scale.

    Impression of Change:
    • PGIC and SGIC

    PK parameters for subjects from Cohort 1 and 3:
    • Plasma GAA activity levels and total GAA protein concentration PK parameters: Cmax, tmax, AUC0-t, AUC0-∞, t½, and CLT.
    • Plasma GAA activity and total GAA protein ratios for Cmax, AUC0-t, and AUC0-∞ for single-dose versus multiple-dose
    • Plasma AT2221 PK parameters: Cmax, tmax, AUC0-t, AUC0-∞, t½, CLT/F, and Vz/F.
    • Plasma AT2221 Cmax, AUC0-t, and AUC0-∞ ratios for single-dose versus multiple-dose.
    • Single-dose plasma GAA activity, total protein and AT2221 Cmax, AUC0-t, and AUC0-∞ ratios for subjects from Cohort 3 versus subjects from Cohort 1 following 20 mg/kg ATB200 alone, 20 mg/kg ATB200 + 130 mg AT2221 single-dose, and 20 mg/kg ATB200 + 260 mg AT2221 single-dose.
    E.5.2.1Timepoint(s) of evaluation of this end point
    n/a
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Australia
    Germany
    Netherlands
    United Kingdom
    United States
    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
    Database lock
    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 months9
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years6
    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: 32
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 32
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-01
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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