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    Summary
    EudraCT Number:2020-001009-22
    Sponsor's Protocol Code Number:19356A
    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:2022-09-13
    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 number2020-001009-22
    A.3Full title of the trial
    Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of IV eptinezumab in adolescents (12-17 years) for the preventive treatment of chronic migraine
    Studio interventistico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo per valutare l’efficacia e la sicurezza di eptinezumab per via endovenosa in adolescenti (12-17 anni) per il trattamento preventivo dell’emicrania cronica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Interventional, placebo-controlled study to evaluate the efficacy and safety of eptinezumab in adolescents (12-17 years) for the preventive treatment of chronic migraine
    Studio interventistico, controllato con placebo per valutare l’efficacia e la sicurezza di eptinezumab in adolescenti (12-17 anni) per il trattamento preventivo dell’emicrania cronica
    A.3.2Name or abbreviated title of the trial where available
    PROSPECT-2
    PROSPECT-2
    A.4.1Sponsor's protocol code number19356A
    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 number+4536301311
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    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
    To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.
    Valutare se eptinezumab sia migliore rispetto al placebo (normale soluzione salina) nel diminuire il numero dei giorni con emicrania in pazienti di età compresa tra 12 e 17 anni con emicrania cronica.
    E.2.2Secondary objectives of the trial
    To evaluate the population pharmacokinetics and immunogenicity of eptinezumab administered IV to patients 12 to 17 years of age with CM
    Valutare la farmacocinetica e l’immunogenicità di popolazione per eptinezumab somministrato per via endovenosa a pazienti affetti da CM di età compresa tra 12 e 17 anni
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.

    - During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 24 of the 28 days following the screening visit.

    - During the 28-day screening period, the participant must have =15 to =26 headache days, of which at least 8 are migraine days as documented in the eDiary.
    - Diagnosi di emicrania (con o senza aura) secondo la 3a edizione della Classificazione internazionale delle cefalee (International Classification Of Headache Disorders, [ICHD-3]) con anamnesi di emicrania cronica da =6 mesi prima della visita di screening

    - Durante il periodo di screening di 28 giorni, il paziente deve compilare adeguatamente l’eDiary sulla cefalea per =23 dei 28 giorni successivi alla visita di screening

    - Durante il periodo di screening di 28 giorni, il paziente deve presentare da =15 a =26 giorni di cefalea, di cui almeno 8 sono giorni di emicrania come documentato nell’eDiary
    E.4Principal exclusion criteria
    - The participant has previously been enrolled in this study and exposed to eptinezumab.

    - The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the screening visit.

    - The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) <6 months prior to the screening visit.

    - The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
    - Il partecipante è stato arruolato in precedenza in questo studio e ha ricevuto Eptinezumab

    - Il partecipante ha ricevuto un anticorpo monoclonale (incluso il trattamento in uno studio di ricerca) < 6 mesi prima della visita di screening

    - Il partecipante ha ricevuto un' alto anticorpo contro CGRP (incluso il trattamento in uno studio di ricerca) < 6 mesi dalla visita di screening

    - Il partecipante ha una sotoria o una diagnosi di emicrania complicata (ICHD-3 version, 2018), mal di testa di tipo tensivo cronico, mal di testa ipnotico, mal di testa a grappolo, emicrania continua, nuovo mal di testa persistente giornaliero o insoliti sottotipi di emicrania come emicrania emiplegica (sporadica e familiare) emicrania con aura tronco encefalica, emicrania oftalmoplegica o emicrania con accompagnamenti neurologici che non sono tipici dell'emicrania aura (diplopia, alterazione della coscienza o di lunga durata)
    E.5 End points
    E.5.1Primary end point(s)
    1. Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
    1. Variazione rispetto al basale dei giorni mensili di emicrania (Monthly Migraine Days, [MMD] Settimane 1-12)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Time Frame: Baseline, Weeks 1-12
    1. Time Frame: dal Baseline, alle settimane 1-12
    E.5.2Secondary end point(s)
    1. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12

    2. Percentage of Participants With Migraine on the Day After Dosing (Day 1)

    3. Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12

    4. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12

    5. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4

    6. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4

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

    8. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12

    9. Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12

    10. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12

    11. Free Eptinezumab Plasma Concentration

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

    13. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) ; 1. Percentuale di partecipanti con riduzione del 50% rispetto al basale nella media di MMD nelle settimane 1-12
    2. Percentuale di partecipanti con emicrania il giorno dopo il trattamento (giorno 1)
    3. Cambio rispetto al basale nella MMD grazie all'uso di farmaci nella fase acuta nelle settimane 1-12
    4. Percentuale dei partecipanti con riduzione del 75% della MMD dal basale alle settimane 1-12
    5. Percentuale dei partecipanti con riduzione del 75% della MMD dal basale alle settimane 1-4
    6. Percentuale dei partecipanti con riduzione del 50% della MMD dal basale alle settimane 1-4
    7. Cambio dal basale nella media mensile dei giorni con mal di testa nelle settimane 1-12
    8. Cambio dal basale nel tasso di emicrania con dolore acuto nelle settimane 1-12
    9. Cambio dal basale nella media dei giorni in cui vengono utilizzati farmaci in fase acuta nelle settimane 1-12
    10. Cambio dal basale nella media del punteggio per il questionario PedMIDAS
    11. Concentrazione nel plasma di Eptinezumab libero
    12. Numero di partecipanti con anticorpi specifici Anti-Eptinezumab (ADA)
    13. Numero di partecipanti con anticorpi neutralizzanti specifici Anti-Eptinezumab (NAb)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Time Frame: Baseline up to Weeks 1-12
    2. Time Frame: Day 1
    3. Time Frame: Baseline, Weeks 1-12
    4. Time Frame: Baseline up to Weeks 1- 12
    5. Time Frame: Baseline up to Weeks 1-4
    6. Time Frame: Baseline up to Weeks 1-4
    7. Time Frame: Baseline, Weeks 1-12
    8. Time Frame: Baseline, Weeks 1-12
    9. Time Frame: Baseline, Weeks 1-12
    10. Time Frame: Baseline, Weeks 1-12
    11. Time Frame: Randomization ( pre-dose [Week 0]), Week 8, Week 12, and safety follow up visit (Week 20)
    12. Time Frame: From randomization (Week 0) up to Week 20
    13. Time Frame: From randomization (Week 0) up to Week 20; 1. Tempistica: dal baseline fino alle settimane 1-12
    2. Tempistica: Giorno 1
    3. Tempistica: Baseline, settimane 1-12
    4. Tempistica: dal baseline fino alle settimane 1-12
    5. Tempistica: dal baseline fino alle s
    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 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 No
    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 trial3
    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 of the protocol. The overall end of the study is defined as the last scheduled procedure shown in Panel 2 of the protocol for the last patient in the study globally.
    La fine dello studio per il singolo paziente è definita con l'ultima procedura programmata come mostrato nel Panel 2 del protocollo. La fine dello studio è definita con l'ultima procedura programmata come mostrato nel Panel 2 del protocollo per l'ultimo paziente a livello globale.
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 285
    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
    The patient has assented to participate in the study and the patient’s parent(s)/legal representative(s) have/has signed the Informed Consent Form prior to the conduct of any study-specific procedures.
    Al paziente verrà chiesto l'assenso per la partecipazione allo studio e il/i genitore/i / legale/i rappresentante/i dovrà/dovranno firmare in consenso informato prima che venga effettuata una qualsiasi procedura studio-specifica.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 285
    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)
    Patients who complete this study may continue into the optional OLE study (19379A) if informed assent/consent has been obtained and the patient is deemed to be eligible, as judged by the investigator
    I pazienti che completeranno questo studio potranno continuare nello studio opzionale OLE (19379A) se verrà ottenuto l'assenso/consenso informato e il paziente risulterà eleggibile a giudizion dell'investigatore.
    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
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