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    Summary
    EudraCT Number:2012-004457-88
    Sponsor's Protocol Code Number:SPD489-346
    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:2014-01-29
    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 number2012-004457-88
    A.3Full title of the trial
    A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years with Moderate to Severe Binge Eating Disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine the maintenance of study drug, SPD489, in adults subjects who are suffering from Binge Eating Disorder
    A.3.2Name or abbreviated title of the trial where available
    SPD489-346
    A.4.1Sponsor's protocol code numberSPD489-346
    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 SponsorShire Development LLC
    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 supportShire Development LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Pharmaceutical Ltd
    B.5.2Functional name of contact pointMedical Communications
    B.5.3 Address:
    B.5.3.1Street AddressHampshire International Business Park
    B.5.3.2Town/ cityChineham, Basingstoke
    B.5.3.3Post codeRG24 8EP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+448000556614
    B.5.5Fax number+441256894714
    B.5.6E-mailmedinfoglobal@shire.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 Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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 Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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, hard
    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
    Binge eating disorder is characterized by recurrent, distressing episodes of uncontrolled consumption of large amounts of food (binge eating) without the inappropriate compensatory weight loss behaviors of bulimia nervosa. In May 2013, BED was formally added as a free standing diagnosis under DSM-5.
    E.1.1.1Medical condition in easily understood language
    Binge eating disorder
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary and Clinical Global Impression – Severity (CGI-S) scores for patients who responded to SPD489 by the end of the Open-label Treatment Phase.
    (Relapse is defined as subject reports with at least 2 or more binge days each week for 2 consecutive weeks [14 days] prior to the visit and have a at least 2 or more point increase in CGI-S score relative to their score at the Randomized-withdrawal Baseline Visit.)
    E.2.2Secondary objectives of the trial
    1 To evaluate the efficacy of SPD489 as compared to placebo at Visit 21 on the number of binge-eating days per week as assessed by clinical interview based on subject diary
    2 To evaluate the efficacy of SPD489 as compared to placebo at Visit 21 on the global clinical measure of severity as measured by the CGI-S scale
    3 To evaluate the efficacy of SPD489 as compared to placebo at Visit 21 on the obsessive/compulsive binge eating symptoms as measured by the Y-BOCS-BE
    4 To evaluate the impact of SPD489 on a measure of the perception of health and quality of life for appraisal of clinical and economic health status as assessed by EQ5D5L.
    5 To evaluate the safety and tolerability of SPD489 based on the occurrence of TEAEs, vitals signs results (including weight and waist circumference), clinical laboratory results, ECG results, and the C-SSRS results .
    6 To evaluate amphetamine withdrawal symptoms as measured by the ACSA in the Follow up Phase.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:

    • Subject is between 18-55 years of age (or age of majority if greater
    than 18 years of age, as defined by local regulations), inclusive, at the
    time of consent.
    • Subject meets DSM-IV-TR criteria for a diagnosis of BED.
    • Subject's BED is of at least moderate severity with subjects reporting
    at least 3 binge eating days per week for the 14 days prior to the
    Baseline Visit (Visit 0) as documented in the subject's binge diary. A
    binge day is a day during which at least 1 binge eating episode occurs.
    • Subject must have a CGI-S score superior or equal to 4 at the
    Screening Visit (Visit -1) and Baseline Visit (Visit 0).
    • Subject has a BMI of superior or equal to 18 and inferior or equal to 45
    at the Screening Visit (Visit -1) and the Baseline Visit (Visit 0).
    • Subject is able to provide written, personally signed, and dated
    informed consent to participate in the study before completing any
    study-related procedures.
    • Subject is willing and has an understanding and ability to fully comply
    with study procedures and restrictions defined in this protocol.
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following exclusion
    criteria are met:
    • Subject has current diagnosis of bulimia nervosa or anorexia nervosa
    as defined by the SCID-I eating disorders module.
    • Subject is receiving psychotherapy (eg, supportive psychotherapy,
    cognitive behavior therapy, interpersonal therapy) or weight loss
    support (eg, Weight Watchers) for BED that began within the 3 months
    prior to the Screening Visit (Visit -1). Subjects who are receiving
    psychotherapy or weight loss support that was initiated >=3 months
    prior to the Screening Visit (Visit -1) will be allowed to continue to
    receive psychotherapy or weight loss support during the study only if
    they agree to not make any changes in the frequency or nature of their
    psychotherapy or weight loss support during the course of this study.
    • Subject has a current comorbid Axis I or Axis II psychiatric disorder
    that is either controlled with medications prohibited in this study or is
    uncontrolled and associated with significant symptoms (note: subjects
    with mild mood or anxiety symptoms that do not meet criteria for Axis I
    disorder, do not require treatment based on the investigator's
    assessment, and do not confound efficacy or safety assessments in the
    opinion of the examining investigator may be included).
    • Subject has a lifetime history of psychosis, mania, hypomania,
    dementia, or ADHD.
    • Subject is considered a suicide risk in the opinion of the investigator,
    has previously made a suicide attempt, or is currently demonstrating
    active suicidal ideation. Subjects with intermittent passive suicidal
    ideation are not necessarily excluded based on the assessment of the
    investigator.
    • Subject has a recent history (within the past 6 months) of suspected
    substance abuse or dependence disorder in accordance with DSM-IV-TR
    criteria. Subjects with a lifetime history of amphetamine, cocaine, or
    other stimulant abuse and/or dependence will be excluded. Nicotine
    dependence is not exclusionary.
    • Subject has a concurrent chronic or acute illness (such as severe
    allergic rhinitis, an infectious process requiring antibiotics, or diabetes),
    disability, or other condition that might confound the results of safety
    assessments administered in the study or that might increase risk to the
    subject. Subject will be excluded if he or she has any additional
    condition(s) that in the investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the
    subject to participate in the study. This would include any significant
    illness or unstable medical condition that could lead to difficulty in
    complying with the protocol. Mild, stable asthma is not exclusionary.
    • Subject has known history of symptomatic cardiovascular disease,
    advanced arteriosclerosis, structural cardiac abnormality,
    cardiomyopathy, serious heart rhythm abnormalities, coronary artery
    disease, or other serious cardiac problems that may place them at
    increased vulnerability to the sympathomimetic effects of a stimulant
    medication.
    • Subject has a known family history of sudden cardiac death or
    ventricular arrhythmia.
    • Subject has any clinically significant ECG prior to the Baseline Visit
    (Visit 0).
    • Subject has any clinically significant laboratory abnormality prior to
    the Baseline Visit (Visit 0). Subjects with hypokalemia at the Screening
    Visit or prior to the Baseline Visit (Visit 0) will be excluded.
    • Subject has a history of moderate or severe hypertension or has a
    resting average (of 3 readings) sitting systolic blood pressure
    >139mmHg or an average (of 3 readings) diastolic blood pressure
    >89mmHg at the Screening Visit (Visit -1) and/or Baseline Visit (Visit
    0). NOTE: Subjects with mild (Stage 1), well-controlled hypertension on
    a stable antihypertensive treatment regimen, defined as having
    maintained the current dose for a period of at least 3 months or longer
    at the time of the Screening Visit (Visit -1), are allowed.
    E.5 End points
    E.5.1Primary end point(s)
    Time to relapse from randomization (Visit 8). The time of relapse is defined as the visit date when the relapse is confirmed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subject Daily Diary Visit 8 - Visit 21
    E.5.2Secondary end point(s)
    1. Change from Visit 8 (Week 12) to Visit 21 (Week 38) in the number of binge days per week
    2. CGI-S at Visit 21/ET (Week 38)
    3. Change from Visit 8 (Week 12) to Visit 21 (Week 38) in Y-BOCS-BE
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Subject Daily Diary Visit 8 - Visit 21
    2. CGI-S: Visit 21/ET
    3. Y-BOCS-BE: Visit 8 and Visit 21
    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 Yes
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open-label, Dose Optimization followed by randomisation based on response
    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 concerned6
    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
    Canada
    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
    The end of the trial is signified by the last patient finishing the last visit (the Follow-up Visit) of the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    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: 412
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 103
    F.4.2.2In the whole clinical trial 412
    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 Decision2014-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-08
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