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    Summary
    EudraCT Number:2016-004422-42
    Sponsor's Protocol Code Number:ESKETINSUI2002
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-10-30
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2016-004422-42
    A.3Full title of the trial
    A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Pediatric Patients at Imminent Risk for Suicide
    A.4.1Sponsor's protocol code numberESKETINSUI2002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/020/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressAchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEsketamine - Nasal Solution - eq 140mg/mL esketamine base (eq 161.4 mg/mL esketamine HCl)
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEsketamine (for (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone)
    D.3.9.3Other descriptive nameESKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB25811
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 Midazolam-ratiopharm
    D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameMidazolam
    D.3.4Pharmaceutical form Oral solution
    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 INNMIDAZOLAM HYDROCHLORIDE
    D.3.9.1CAS number 59467-96-8
    D.3.9.4EV Substance CodeSUB03289MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboNasal spray, solution
    D.8.4Route of administration of the placeboNasal use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    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
    Major Depressive Disorder with Imminent Risk of Suicide
    E.1.1.1Medical condition in easily understood language
    Depression with Risk of Suicide
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10042458
    E.1.2Term Suicidal ideation
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012397
    E.1.2Term Depression suicidal
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10065604
    E.1.2Term Suicidal behaviour
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    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 is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine (28 mg, 56 mg, and 84 mg) compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of MDD, including suicidal ideation, in subjects 12 to <18 years of age who are assessed to be at imminent risk for suicide. Efficacy will be assessed by the change from baseline in Children’s Depression Rating Scale, Revised (CDRS-R)
    total score at 24 hours post first dose (Day 2).
    E.2.2Secondary objectives of the trial
    -To evaluate the dose response of intranasal esketamine compared with psychoactive placebo in reducing the symptoms of MDD, including suicidal ideation, as assessed by the change from baseline in CDRS-R total score at 24 hours post first dose (Day 2) and at Day 25.
    -To evaluate the efficacy of single and repeated doses of intranasal esketamine compared with psychoactive placebo in reducing symptoms of suicidal ideation, as assessed by the Clinical Global Impression of Severity of Suicidality, revised version (CGI-SS-R) from the Suicide Ideation and Behavior Assessment Tool (SIBAT) at 4 hours and 24 hours post first dose and through the end of the double-blind treatment phase (Day 25).
    -To evaluate the efficacy of single and repeated doses of intranasal esketamine compared with psychoactive placebo in reducing symptoms of MDD
    -For more information on secondary objectives see Protocol section 2.1.1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female adolescents (12 to <18 years of age)
    2. Subject must meet DSM-5 diagnostic criteria for MDD, without psychotic features, based upon clinical assessment and confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI KID).
    3. Subject must have current suicidal thinking with intent at the time of screening, confirmed by “Yes” responses to both MINI-KID Question B3 (Think about hurting yourself with the possibility that you might die. Or did you think about killing yourself?) AND Question B10 (Expect to go through with a plan to kill yourself?).
    4. In the physician’s opinion, acute psychiatric hospitalization is clinically warranted due to subject’s imminent risk of suicide.
    5. Subject must have a CDRS-R total score of ≥ 58 predose on Day 1.
    6. As part of standard of care treatment, subject must agree to be hospitalized voluntarily for a recommended period of 5 days after randomization (may be shorter or longer if clinically warranted in the investigator’s opinion).
    7. As part of the newly initiated or optimized standard of care treatment, subject must agree to take one of the prescribed non-investigational antidepressants medications (fluoxetine, escitalopram, sertraline) at least during the double-blind treatment phase (Day 25).
    8. As part of standard of care treatment, subject must agree to participate in a specific psychological intervention (individual cognitive behavioral therapy [CBT], interpersonal therapy, family therapy or psychodynamic psychotherapy) at least through the initial 8-week post-treatment follow-up period (Day 81).
    9. Subject is comfortable with self-administration of intranasal medication and able to follow instructions provided.
    10. Subject must be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. If there are abnormalities, the subject may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the investigator.
    11. Subject must be medically stable on the basis of clinical laboratory tests performed by the local laboratory at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the investigator.
    12. During the double-blind treatment phase and for at least 6 weeks after the last dose of study drug, contraception is required. Sexual abstinence is strongly recommended; however heterosexually active female subjects must practice a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly).
    13. A female subject of childbearing potential must have a negative urine pregnancy test at screening, baseline, and end of double-blind phase.
    14. Subject must be willing and able to participate in all study activities and to adhere to the prohibitions and restrictions specified in this protocol (Section 4.3).
    15. Subject’s parent (or legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to allow the subject to participate in the study. Assent is also required of subjects as described in Section 16.2.3, Informed Consent and Assent.
    16. Subject’s parent (or legally acceptable representative) must sign a separate informed consent form if he or she agrees to provide an optional DNA sample for research (where local regulations permit). Refusal to give consent for the optional DNA research sample does not exclude a subject from participation in the study.

    For further information on inclusion criteria see protocol section 4.1.
    E.4Principal exclusion criteria
    1. Subject has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, anorexia nervosa, oppositional defiant disorder, or obsessive compulsive disorder.
    2. Subject currently meets DSM-5 criteria for borderline personality disorder.
    Subjects not meeting full DSM-5 criteria for borderline personality disorder but exhibiting recurrent suicidal gestures, threats, or self-mutilating behaviors should also be excluded.
    3. Subject has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis.
    4. Subject meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder (except for nicotine or caffeine) within the 6 months before screening.
    5. Subject has a history of seizure disorder.
    6. Subject has a history or current signs and/or symptoms of liver or renal insufficiency; has a current diagnosis of clinically significant cardiac (eg, congenital heart disease, cardiomyopathy, or tachyarrhythmias), vascular, pulmonary, gastrointestinal, endocrine (including uncontrolled hyperthyroidism), neurologic, hematologic, rheumatologic, or metabolic (including severe dehydration/hypovolemia) disease based on investigator judgment.
    7. Subject has uncontrolled hypertension (SBP and/or DBP that is greater than or equal to the 95th percentile for sex, age, and height) despite diet, exercise or a stable dose of an allowed anti-hypertensive treatment at screening; or any past history of hypertensive crisis. See Attachment 2 for pediatric blood pressure tables with percentile ranking by age, sex, and height for determination of hypertensive status. On Day -1 (screening) or Day 1 of the double-blind phase prior to randomization, a supine or semi-supine SBP and/or DBP ≥ the 95th percentile for sex, age and height is exclusionary (see Attachment 3). Subjects who fall below the 5th or above the 95th percentile for their age, sex, and height should be evaluated using the parameters for the 5th or 95th percentile. Note that subjects whose SBP and/or DBP values are ≥ the 95th percentile for sex, age and height may be reevaluated with a repeated measure once after 5 minutes of rest to assess eligibility. Subjects with conditions in which blood pressure elevation could pose a serious risk (including severe cardiovascular disease, recent cerebral injury, increased intracranial pressure / intracranial mass lesion, intracranial bleeding or acute stroke, primary developmental or secondary acquired glaucoma or perforating eye injury) are excluded.
    8. Subject has a positive urine test result(s) for phencyclidine (PCP), cocaine, methamphetamines, or amphetamines/3,4-methylenedioxy-methamphetamine (MDMA) at screening. Subjects known to be using heroin should be excluded from the study.
    9. Subject has a history of malignancy within 5 years before screening, with the exception of a malignancy that, in the opinion of the investigator and in concurrence with the sponsor's medical monitor, is considered to have minimal risk of recurrence.
    10. Subject has anatomical or medical conditions that may impede delivery or absorption of intranasal study medication.
    11. Subject has an abnormal or deviated nasal septum with any 1 or more of the following symptoms: blockage of 1 or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, and frequent sinus infections (and at times has facial pain, headaches, and postnasal drip with the sinus infection).
    12. Subject has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients.
    13. Subject has taken any disallowed therapy(ies) as noted in Section 8, Prestudy and Concomitant Therapy and Attachment 1.
    14. Subject has received an investigational drug (including esketamine, ketamine, or investigational vaccines) or used an invasive investigational medical device within 60 days before the first dose of study drug or is currently enrolled in an investigational study.
    15. Subject is a female who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study drug.
    16. Subject has any situation or condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    17. Subject, parent or legal guardian is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.

    For further information on exclusion criteria see protocol section 4.2.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy evaluation will be the change from baseline (Day 1, predose) in depressive symptoms, including suicidal ideation, as measured by the CDRS-R total score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours post first dose
    E.5.2Secondary end point(s)
    1.) Dose response as assessed by CDRS-R
    2.) Change from baseline in CDRS-R
    3.) Change from baseline in MADRS
    4.) Change from baseline in CGI-SS-R from SIBAT
    5.) Change from baseline in SIBAT
    6.) Change from baseline in CDI 2:SR [S]

    For additional endpoints, see protocol section 2.1.2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.) 24 hours post first dose
    2.) Post single/repeated doses, at 4 hours post first dose, through the end of the double-blind treatment phase, and during the 6-month post-treatment follow-up phase.
    3.) Post single/repeated doses, at 4 hours and 24 hours post first dose, through the end of the double-blind treatment phase, and during the 6-month post-treatment follow-up phase.
    4.) Post single/repeated doses at 4 hours and 24 hours post first dose, through the end of the double-blind treatment phase (Day 25).
    5.) Post single/repeated doses, through the end of the double-blind treatment phase (Day 25) and during the 6-month post-treatment follow-up phase
    6.) Post single/repeated doses, at 24 hours post first dose and through the end of the double-blind treatment phase (Day 25).
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    psychoactive placebo (midazolam)
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Belgium
    Brazil
    Bulgaria
    France
    Hungary
    Italy
    Poland
    Spain
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days24
    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: 145
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 145
    F.1.2Adults (18-64 years) No
    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 Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 79
    F.4.2.2In the whole clinical trial 145
    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)
    The study investigator must ensure the subject is appropriately transitioned and/or followed for any additional care required. Subjects should continue with their standard of care after the end of the study per investigator's or
    the treating physician's clinical judgement. This should be planned for in advance of each patient's completion of the study and based on their individual clinical needs.
    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 Decision2018-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
    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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