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    Summary
    EudraCT Number:2019-002056-16
    Sponsor's Protocol Code Number:TV48125-CNS-30084
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-08-31
    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 ConcernedGermany - PEI
    A.2EudraCT number2019-002056-16
    A.3Full title of the trial
    A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
    A.3.2Name or abbreviated title of the trial where available
    SPACE
    A.4.1Sponsor's protocol code numberTV48125-CNS-30084
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/411/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTeva Branded Pharmaceutical Products R&D, 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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerckle GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGraf-Arco-Str.3
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89079
    B.5.3.4CountryGermany
    B.5.6E-mailInfo.Era-clinical@teva.de
    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 AJOVY
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA 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.3.1Product namefremanezumab
    D.3.2Product code TEV-48125
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfremanezumab
    D.3.9.1CAS number 1655501-53-3
    D.3.9.2Current sponsor codeTEV-48125
    D.3.9.4EV Substance CodeSUB181665
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    D.2.1.1.1Trade name AJOVY
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA 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.3.1Product namefremanezumab
    D.3.2Product code TEV-48125
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfremanezumab
    D.3.9.1CAS number 1655501-53-3
    D.3.9.2Current sponsor codeTEV-48125
    D.3.9.4EV Substance CodeSUB181665
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.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
    Episodic and Chronic Migraine
    E.1.1.1Medical condition in easily understood language
    Episodic and Chronic Migraine
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066636
    E.1.2Term Chronic migraine
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10082019
    E.1.2Term Episodic migraine
    E.1.2System Organ Class 100000004852
    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 the longterm safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric patients 6 to 17 years of age (inclusive at enrollment in the pivotal study)
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of subcutaneous fremanezumab in pediatric patients with migraine
    -To evaluate the immunogenicity of fremanezumab and the impact of ADAs on clinical outcomes in pediatric patients exposed to fremanezumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients Rolling Over from the Pivotal Efficacy Studies may be included only if they meet all of the following criteria:
    a. Completion of the pivotal efficacy study and in the opinion of the
    Investigator/Sponsor able to complete the study in a safe and compliant way
    b. Patient’s parent(s) or legal guardian(s) must give written informed consent, and the patient must give assent (in accordance with local regulations) Note: In some countries, patients aged 15 to 17 years (inclusive) may give written informed consent; however, the patient’s parent(s) or legal guardian(s) must be informed, per local regulations.
    c. Patients may continue with a stable dose/regimen of the preventive medication they were taking during the pivotal efficacy studies
    d. Willing and able to comply with study restrictions and to remain
    at the clinic for the required duration during the study period and willing to return to the clinic for the follow-up evaluation as specified in this protocol
    e. Patient continues to meet appropriate criteria carried forward from the pivotal efficacy study, as follows:
    f. Females who are postmenarchal or ≥12 years of age may be included only if they have a negative beta-human chorionic gonadotropin (β-HCG) test at baseline or are sterile
    g. Females who are postmenarchal or ≥12 years of age and sexually active must use highly effective birth control methods with their male partners for the duration of the study (ie, at least 2 months before screening) and for 6 months after the last dose of IMP. Males who are sexually active with female partners must use a condom for the duration of the study and for 6 months after the last administration of IMP
    h. Receipt of all recommended age-appropriate vaccines according to local standard of care and schedule
    i. Good health, determined by a medical and psychiatric history,
    medical examination, 12-lead ECG, serum chemistry, hematology, coagulation, urinalysis, and serology
    j. Weight of at least 17.0 kg on the day of study enrollment
    k. BMI ranging from the 5th to the 90th percentile, incl. on the day of randomization

    Patients Rolling Over from Study TV48125-CNS-10141: may be included only if they meet all of the following criteria
    a. Patient is male/female, 6 - 17 years old (inclusive)
    b. Written informed consent is obtained from each patient's parent or legal guardian and written assent (according to local regulations) is obtained from each patient. Note: In some countries, patients aged 15 to 17 years (inclusive) may give written informed consent; however, the patient’s parent(s) or legal guardian(s) must be informed, per local regulations.
    c. The patient/caregiver has demonstrated compliance with the electronic headache diary during the 28-day baseline period by entry of headache data on a minimum of 21 out of 28 days (approximately 75% diary compliance)
    d. Females who are postmenarchal or ≥12 years of age may be included only if they have a negative β-HCG test at the screening/pre-treatment period or are sterile
    e. Females who are postmenarchal or ≥12 years of age and sexually active must use highly effective birth control methods with their male partners for the duration of the study (ie, at least 2 months before screening) and for 6 months after the last dose of the IMP. Males who are sexually active with female partners must use a condom for the duration of the study and for 6 months after the last administration of the IMP
    f. The patient has received all recommended age-appropriate vaccines according to local standard of care and schedule
    g. The patient is in good health as determined by a medical and psychiatric history, medical examination, 12-lead ECG, serum chemistry, hematology, coagulation, urinalysis, and serology
    h. The patient/caregiver must be willing and able to comply with study requirements and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol
    i. Weight of at least 17.0 kg on the day of study enrollment
    j. BMI ranging from the 5th to the 90th percentile,
    inclusive, on the day of study enrollment
    k. Not using preventive medications or using no more than 1 preventive medication for migraine or other medical condition, as long as the dose and regimen have been stable for at least 2 months prior to screening (visit 1)

    Note: A person is considered to be not using preventive medications when at least 5 half-lives have passed since the last use of the medication prior to screening (visit 1) or at least 4 months have passed since the last use of Onabotulinium toxin A or B prior to screening (visit 1).

    Patients Rolling Over from the Pivotal Efficacy Studies for Safety
    and ADA Assessment Only: Inclusion in study if they sign and date the informed consent document or upon consent of a parent or guardian, if the patient is younger than the age of consent, accompanied by assent of the patient.
    E.4Principal exclusion criteria
    Patients from the Pivotal Efficacy Studies (any criteria met):
    a. Significant abnormal finding on study entry (e.g. hematology), repeat abnormal tests for confirmation
    b. Pregnant, nursing, or taking a combined estrogen and progestogen hormonal contraceptive
    c. Abnormal clinically significant finding on baseline 12-lead ECG
    d. One of the following criteria is met:
    e. Use of medications containing opioids (incl. codeine), barbiturates (incl. Fiorinal®, any other combination containing butalbital) for migraine treatment during the 3 months prior to screening visit day
    f. Use of an intervention/device (eg, scheduled nerve block) for migraine treatment during the 2 months prior to screening visit day
    g. Any clinically significant disease (e.g. cardiovascular), or complications of an infection
    h. History of clinically significant psychiatric condition/history of a suicide attempt/history of suicidal ideation with a specific plan within the past 2 years, at the discretion of the investigator.
    i. Ongoing infection/known history of e.g. HIV infection/tuberculosis, Lyme disease, chronic hepatitis B or C, or a known infection of coronavirus disease 2019 (COVID-19)
    j. Past or current history of cancer
    k. History of hypersensitivity reactions to injected proteins, incl. mAbs, history of Stevens-Johnson Syndrome, toxic epidermal necrolysis syndrome, or the patient in concomitantly using lamotrigine.
    l. Current participation in another IMP/medical device study
    m. Hepatic enzymes (ALT, AST, ALP) > 1.5× ULN after a repeat test confirmation, or suspected hepatocellular damage (fulfilling Hy’s law)
    n. Serum creatinine > 1.5× the ULN, clinically significant proteinuria (urine dipstick +4), an estimated glomerular filtration rate of
    <90 mL/min/1.73m2, as calculated by the Schwartz formula (CrCl=[k×Ht]/Serum Creatinine), or evidence of renal disease
    o. Patient cannot fully participate in/successfully complete the study for its full duration for any of the following reasons:
    -In custody due to an administrative or a legal decision or in residential treatment
    -Patient/caregiver unable to be contacted in case of emergency
    -Presence of any other condition, which makes the patient inappropriate for study inclusion
    -Patient is a relative of a study center or sponsor employee who is directly involved in the study
    p. Vulnerable patients (eg, people in detention) that are vulnerable due to other conditions than age
    q. Receipt of a live attenuated vaccine (eg, intranasal flu vaccine) within the 12-week period prior to screening/plans to receive such a vaccine at any time during the study/for 6 months after the last dose of IMP
    r. The patient has a known hypersensitivity to the active substance or to any of the excipients of the study drug.

    Patients from Study TV48125-CNS-10141 (any criteria met):
    a. Use of an intervention/device (eg, scheduled nerve block) for the migraine treatment during the 2 months prior to screening visit day.
    b. Any clinically significant disease (e.g. cardiovascular)/complications of an infection
    c. Current history of clinically significant psychiatric condition/history of a suicide attempt/suicidal ideation with a specific plan within the past 2 years, at discretion of investigator
    d. Ongoing infection/known history of e.g. HIV infection/tuberculosis/Lyme disease/chronic hepatitis B or C, COVID-19
    e. Past or current history of cancer
    f. Pregnant/nursing patient, or taking a combined estrogen and progestogen hormonal contraceptive
    g. History of hypersensitivity reactions to injected proteins, incl. mAbs/history of Stevens-Johnson Syndrome/toxic epidermal necrolysis syndrome, or patient is concomitantly using lamotrigine
    h. Participation in another study of an IMP/medical device within 30 days/ 90 days for biologics or 5 half-lives previous to screening visit day (whichever is longer) or current participation in another study of an IMP/medical device
    i. Exposure to a mAb targeting the calcitonin gene-related peptide pathway (erenumab, eptinezumab, galcanezumab, fremanezumab) during the 6 months prior to screening visit day
    j. Abnormal finding on the baseline 12-lead ECG considered clinically significant
    k. Clinically significant abnormal finding on screening visit day, incl. hematology, blood chemistry, coagulation tests, urinalysis values/findings (repeat abnormal tests for confirmation)
    l. Hepatic enzymes (ALT, AST, ALP) > 1.5× the ULN on screening visit day after confirmation in a repeat test/suspected hepatocellular damage (fulfilling Hy’s law)
    m. Serum creatinine > 1.5× the ULN, clinically significant proteinuria (urine dipstick +4), an estimated glomerular filtration rate of
    <90 mL/min/1.73m2, as calculated by the Schwartz formula (CrCl=[k×Ht]/Serum Creatinine), or evidence of renal disease on the day of the screening visit.
    n. The patient has any history of alcohol or drug abuse
    Remainder of criteria applies as per the study protocol

    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    -Occurrence of adverse events throughout the study, including local injection site reactions/pain
    -Changes from baseline in clinical laboratory (serum chemistry, hematology, coagulation, and urinalysis) test results and height and weight measurements taken at V5, V8, and at the end of treatment (V11)
    -Abnormal standard 12-lead electrocardiogram findings at each study visit up to the end of treatment (V11)
    -Changes from baseline in vital signs (pulse, systolic and diastolic blood pressure, temperature, and respiratory rate) at each study visit up to the end of treatment (V11)
    -Abnormal physical examination findings at study visits V6, V7, V11, and V12
    -Suicidal ideation and behavior as suggested by the Columbia-Suicide Severity Rating Scale throughout the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Safety will be assessed throughout the study
    E.5.2Secondary end point(s)
    Efficacy:
    -Mean change from baseline (defined as the original baseline from the EM and CM studies) in the number of headache days of at least moderate severity during the 4-week periods after V2, V6, and V10
    -Mean change from baseline (defined as the original baseline from the EM and CM studies) in the number of migraine days during the 4-week periods after V2, V6, and V10
    -Proportion of patients reaching at least 50% reduction in the number of migraine days during the 4-week periods after V2, V6, and V10
    -Proportion of patients reaching at least 50% reduction in the number of headache days of at least moderate severity during the 4-week periods after V2, V6, and V10
    -Mean change from baseline (defined as the original baseline from the EM and CM studies) in the number of days of use of any acute headache medications during the 4-week periods after V2, V6, and V10
    -Mean change from baseline (day 1) in migraine-related disability score, as measured by the PedMIDAS questionnaire at V5, V8, V11, and V12
    -Proportion of patients developing ADAs throughout the study. The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive patients allows
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Efficacy will be assessed through
    V11 (end of treatment)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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) 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 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.8.2.4Number 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 EEA30
    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
    Finland
    Germany
    Israel
    Italy
    Netherlands
    Poland
    Spain
    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
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 550
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 151
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 399
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Study patients are minors
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 193
    F.4.2.2In the whole clinical trial 550
    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)
    There will be no access to IMP after the end of the study. The investigator should advise the patients to return to their primary physician.
    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 Decision2020-08-31
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    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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