Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-001649-38
    Sponsor's Protocol Code Number:19379A
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001649-38
    A.3Full title of the trial
    Long-term, open-label (dose-blinded), extension study of eptinezumab in children and adolescents with chronic or episodic migraine
    Studio di estensione a lungo termine, in aperto (con dose mascherata) di eptinezumab in bambini e adolescenti affetti da emicrania cronica o episodica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term extension study of eptinezumab in children and adolescents with chronic or episodic migraine
    Studio di estensione a lungo termine di eptinezumab in bambini e adolescenti affetti da emicrania cronica o episodica
    A.3.2Name or abbreviated title of the trial where available
    REJOIN
    REJOIN
    A.4.1Sponsor's protocol code number19379A
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/091/2022
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorH. LUNDBECK A/S
    B.1.3.4CountryDenmark
    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 supportH. Lundbeck A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationH. Lundbeck A/S
    B.5.2Functional name of contact pointLundbeckClinicalTrials@lundbeck.com
    B.5.3 Address:
    B.5.3.1Street AddressOttiliavej 9
    B.5.3.2Town/ cityValby
    B.5.3.3Post code2500
    B.5.3.4CountryDenmark
    B.5.4Telephone number004536301311
    B.5.5Fax number004536301311
    B.5.6E-mailLundbeckClinicalTrials@lundbeck.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 Vyepti
    D.2.1.1.2Name of the Marketing Authorisation holderH. Lundbeck A/S
    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 nameEptinezumab
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Concentrate for solution for 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 INNEptinezumab
    D.3.9.2Current sponsor codeLu AG09221
    D.3.9.4EV Substance CodeSUB188646
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Migraine
    Emicrania
    E.1.1.1Medical condition in easily understood language
    Migraine
    Emicrania
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10027599
    E.1.2Term Migraine
    E.1.2System Organ Class 10029205 - Nervous system 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 main goal of the study is to assess the long-term safety of eptinezumab in children and adolescents ages 6 to 17 with chronic or episodic migraine.
    Valutare la sicurezza a lungo termine di eptinezumab somministrato per via endovenosa (EV) in pazienti pediatrici di età compresa tra 6 e 17 anni, affetti da emicrania cronica o sporadica
    E.2.2Secondary objectives of the trial
    Not Applicable
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.
    Il partecipante deve aver completato la visita Week 12 (visita di completamento) degli studi 19356A (CM) oppure 19357A (EM) immediatamente prima di essere arruolato in questo studio OLE.
    E.4Principal exclusion criteria
    - The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator.

    - During lead-in Study19356A or Study19357A:
    * participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator

    * the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value >5 times the upper limit of the reference range that was confirmed by testing <2 weeks later.

    * the participant had a serum ALT or AST value >3times the upper limit of the reference range and a serum total bilirubin value >2times the upper limit of the reference range.
    - Il partecipante ha avuto un evento avverso o altri problemi di sicurezza che si presume siano collegati al trattamento ricevuto nello studio principale e questo viene considerato come un fattore di rischio dallo sperimentatore.

    - Durante gli studi 19356A e 19357A:

    il partecipante ha avuto reazioni anafilattiche o un altro tipo di reazioni o ipersensitività gravi all'infusione del farmaco in studio, come riscontrato dallo sperimentatore

    il partecipante ha avuto un valore di ALT o AST >5 volte il limite superiore del range di riferimento e questo dato è stato confermato da un test effettuato <2 settimane dopo

    il partecipante ha avuto un valore di ALT o AST >3 volte il limite superiore del range di riferimento e un valore totale di bilirubina serica >2 volte il limite superiore del range di riferimento
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of Participants With Treatment Emergent Adverse Events
    1 . Numero di partecipanti che mostrano eventi avversi dovuti al trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Time Frame: Baseline up to Week 44
    1. Dal basale fino alla settimana 44
    E.5.2Secondary end point(s)
    1. Free Eptinezumab Plasma Concentration

    2. Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])

    3. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)

    4. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36

    5. Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12

    6. Change From Baseline in Monthly Migraine Days Averaged Over Weeks 1-12

    7. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12
    1. Concentrazione nel plasma di Eptinezumab libero
    2. Numero di partecipanti con anticorpi anti-Eptinezumab (ADA)
    3. Numero di partecipanti con anticorpi anti-Eptinezumab ad attività neutralizzante (NAb)
    4. Cambio del punteggio, rispetto al livello basale, nel questionario PedMIDAS alle settimane 12, 24 e 36
    5. Cambio rispetto al basale nella media dei giorni con episodi di mal di testa nel corso delle prime 12 settimane
    6. Cambio rispetto al basale nella media dei giorni con episodi di emicranea nel corso delle prime 12 settimane
    7. Cambio rispetto al basale nel tasso di emicranee con alta intensità del dolore nel corso delle prime 12 settimane
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Time Frame: Baseline, Weeks 8, 12, 24, 36, and 44
    2. Time Frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
    3. Time Frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
    4. Time Frame: Baseline, Weeks 12, 24, and 36
    5. Time Frame: Baseline, Weeks 1-12
    6. Time Frame: Baseline, Weeks 1-12
    7. Time Frame: Baseline, Weeks 1-12
    1. Intervallo: basale, settimane 8, 12, 24, 36 e 44
    2. Intervallo: basale (settimana 0), settimane 8, 12, 24, 36 e 44
    3. Intervallo: basale (settimana 0), settimane 8, 12, 24, 36 e 44
    4. Intervallo: basale, settimane 12, 24 e 36
    5. Intervallo: basale, settimane 1-12
    6. Intervallo: basale, settimane 1-12
    7. Intervallo: basale, settimane 1-12
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Canada
    Mexico
    United States
    Spain
    Italy
    Portugal
    Turkey
    United Kingdom
    Serbia
    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
    The end of the study for an individual patient is defined as the last scheduled procedure shown in Panel 2. The overall end of the study is defined as the last scheduled procedure shown in Panel 2 for the last patient in the study globally.
    La fine dello studio per un singolo paziente viene definita come l'ultima procedura prevista come mostrato nel Pannello 2. La fine dello studio al livello globale viene definita come l'ultima procedura prevista per l'ultimo paziente, come mostrato nel Pannello 2.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    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: 90
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 555
    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
    Additional consent is required by either parent or legal representative
    Viene richiesto un consenso aggiuntivo per i genitori o il rappresentante legale.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 645
    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)
    Post-study access to the IMP will not be available. Patients in the study will have access to appropriate medical care according to current clinical practice after they complete or withdraw from the study.
    L'accesso al farmaco al termine dello studio non è concesso. I pazienti dello studio riceveranno le appropriate cure mediche in accordo alla pratica clinica dopo che avranno completato lo studio o si saranno ritirati.
    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 Decision2022-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-11
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 20:54:58 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA