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    Summary
    EudraCT Number:2021-003049-40
    Sponsor's Protocol Code Number:20007A
    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 number2021-003049-40
    A.3Full title of the trial
    Interventional, randomized, double-blind, parallel-group, placebo-controlled study of add-on eptinezumab treatment to brief educational intervention for the preventive treatment of migraine in patients with dual diagnosis of migraine and medication overuse headache
    Studio interventistico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo su eptinezumab come trattamento aggiuntivo a un breve intervento educativo per il trattamento preventivo dell’emicrania in pazienti con doppia diagnosi di emicrania e mal di testa da abuso di farmaci
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache
    Studio con eptinezumab in pazienti con emicrania e mal di testa da abuso di farmaci
    A.3.2Name or abbreviated title of the trial where available
    RESOLUTION
    RESOLUTION
    A.4.1Sponsor's protocol code number20007A
    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 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.5.6E-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 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 nameVYEPTI
    D.3.2Product code [ALD403]
    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 typeequal
    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 and medication overuse headache
    Emicrania e mal di testa da abuso di farmaci
    E.1.1.1Medical condition in easily understood language
    Migraine and medication overuse headache
    Emicrania e mal di testa da abuso di farmaci
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications.

    Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH
    Il mal di testa da uso eccessivo di farmaci (MOH) è un tipo di mal di testa causato da uso eccessivo di farmaci per il mal di testa acuto o per l'emicrania (farmaci usati per trattare un mal di testa o un'emicrania una volta iniziata). Il trattamento dell' MOH di solito comporta la riduzione della dose o la sospensione dei farmaci acuti.
    Eptinezumab è un farmaco utilizzato per il trattamento preventivo di emicrania negli adulti. Gli obiettivi principali di questo studio sono di sapere se eptinezumab aiuta a ridurre il numero di giorni con emicrania, il numero di giorni con mal di testa e uso acuto di farmaci negli adulti che soffrono di emicrania e MOH.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of eptinezumab as add-on to BI on healthrelated quality of life and work productivity
    - To evaluate the efficacy of eptinezumab during the 12-week open-label extension period
    - Valutare l’efficacia di eptinezumab come terapia aggiuntiva al BI sulla qualità della vita correlata alla salute e sulla produttività lavorativa
    - Valutare l’efficacia di eptinezumab durante il periodo di estensione in aperto di 12 settimane
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
    - The participant has 8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
    - The participant has 15 headache days per month for each month within the past 3 months prior to the Screening Visit.
    - The participant has had an onset of migraine diagnosis at < = 50 years of age.
    - Il paziente presenta una diagnosi di CM secondo la definizione delle linee guida IHS ICHD-3 confermata alla visita di screening
    - Il paziente presenta 8 giorni di emicrania al mese per ogni mese negli ultimi 3 mesi che precedono la visita di screening
    - Il paziente presenta 15 giorni di mal di testa al mese per ogni mese negli ultimi 3 mesi che precedono la visita di screening
    - Il paziente ha avuto una diagnosi di emicrania a un’età < = 50 anni
    E.4Principal exclusion criteria
    - The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome).
    - The participant has a diagnosis of acute or active temporomandibular disorders.
    - The participant has a history or diagnosis of 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), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
    - The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit.
    - The participant has a history of clinically significant cardiovascular disease including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
    - Il paziente presenta sindromi dolorose confondenti e clinicamente significative (per esempio, fibromialgia, lombalgia cronica e sindrome dolorosa regionale complessa).
    - Il paziente presenta una diagnosi di disturbi temporomandibolari acuti o attivi.
    - Il paziente presenta un’anamnesi o diagnosi di mal di testa cronico di tipo tensivo, mal di testa ipnico, mal di testa a grappolo, emicrania continua, nuovo mal di testa persistente giornaliero o sottotipi insoliti di emicrania come emicrania emiplegica (sporadica e familiare), neuropatia oftalmica dolorosa ricorrente, emicrania con aura del tronco encefalico ed emicrania con sintomi neurologici concomitanti non tipici dell’aura emicranica (diplopia, alterazione dello stato di coscienza o lunga durata).
    - Il paziente è affetto da psicosi, mania bipolare, demenza o qualsiasi altra condizione psichiatrica i cui sintomi non sono controllati o che non sono stati adeguatamente trattati per un minimo di 6 mesi prima della visita di screening.
    - Il paziente presenta un’anamnesi di malattia cardiovascolare clinicamente significativa, tra cui ipertensione non controllata, ischemia vascolare o eventi tromboembolici (per esempio, ictus cerebrovascolare, trombosi venosa profonda o embolia polmonare).
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline in the number of Monthly Migraine Days (MMDs)
    - Variazione rispetto al basale nel numero di giorni mensili di emicrania
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Weeks 1-4
    Dal basale alle settimane 1-4
    E.5.2Secondary end point(s)
    1 Change from baseline in MMDs
    2 Change from baseline in the number of Monthly Headache Days (MHDs)
    3 Change From Baseline in Average Daily Pain Assessment Score
    4 Change From Baseline in Monthly Days with Acute Medication Use
    5 Percentage of Participants Not Fulfilling the lnternational Classification of Headache Disorders (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM)
    6 Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH
    7 Change From Baseline in MMDs with Acute Medication Use
    8 Change from Baseline in Monthly Days of Medication Use (triptans, ergotamine, non-opioids, opioids, and combination analgesics)
    9 Percentage of Participants with Migraine on the Day After Dosing
    10 Response: =50% Reduction From Baseline in MMDs
    11 Response: =75% Reduction From Baseline in MMDs
    12 Response: =50% Reduction From Baseline in MHDs
    13 Response: =75% Reduction From Baseline in MHDs
    14 Change from Baseline in Rate of Migraines and Headaches with Severe Pain Intensity
    15 Patient Global Impression of Change (PGIC) Score
    16 Change in Most Bothersome Symptom (MBS) Score
    17 Change From Baseline in the Headache Impact Test (HIT-6) Total score
    18 Change From Baseline in the Migraine Disability Assessment (mMIDAS) Total Score
    19 Change From Baseline in the Migraine-Specific Quality of Life (MSQ v2.1) Sub-Scores
    20 Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score
    21 Change From Baseline in Health Care Resources Utilisation (HCRU) Score
    22 Change From Baseline in Work Productivity as Measured Using the Work Productivity and Activity Impairment Questionnaire (WPAI) Sub-Scores
    23 Change From Baseline in Hospital Anxiety and Depression (HADS) Sub-Scores
    24 Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (9 Items) (TSQM-9) Score
    1 Variazione rispetto al basale negli MMD
    2 Variazione rispetto al basale nel numero di giorni mensili di mal di testa
    3 Variazione rispetto al basale nel punteggio medio della valutazione del dolore giornaliero
    4 Variazione rispetto al basale nei giorni mensili con ricorso ai farmaci per episodi acuti
    5 Percentuale dei partecipanti che non soddisfano i criteri diagnostici ICHD-3 per CM
    6 Percentuale dei partecipanti che non soddisfano i criteri diagnostici ICHD-3 per MOH
    7 Variazione rispetto al basale degli MMD con ricorso ai farmaci per episodi acuti
    8 Variazione rispetto al basale nei giorni mensili con ricorso ai farmaci (triptano, ergotamina, non oppioidi, oppioidi e in combinazione con analgesici)
    9 Percentuale di partecipanti con emicrania il giorno dopo la somministrazione della dose
    10 Risposta: riduzione =50% rispetto al basale degli MMD
    11 Risposta: riduzione =75% rispetto al basale degli MMD
    12 Risposta: riduzione =50% rispetto al basale degli MHD
    13 Risposta: riduzione =75% rispetto al basale degli MHD
    14 Variazione rispetto al basale del tasso di emicranie con intensità del dolore grave
    15 Punteggio dell’Impressione globale del paziente sul cambiamento
    16 Punteggio del sintomo più fastidioso sul cambiamento
    17 Variazione dal basale nel punteggio totale del Test sull’impatto del mal di testa (HIT-6)
    18 Variazione dal basale nel punteggio totale della Valutazione modificata dell’invalidità da emicrania (mMIDAS)
    19 Variazione dal basale nei sottopunteggi del Questionario sulla qualità della vita specifico per l’emicrania (MSQ v2.1)
    20 Variazione dal basale nel punteggio della scala analogica visiva (VAS) del Questionario europeo sulla qualità della vita a 5 dimensioni e 5 livelli (EQ-5D-5L)
    21 Variazione dal basale nel punteggio di utilizzo delle risorse sanitarie (HCRU)
    22 Variazione dal basale nei sottopunteggi del Questionario sulla compromissione della produttività lavorativa e delle attività nell’emicrania (WPAI)
    23 Variazione dal basale nei sottopunteggi della Scala della depressione e dell’ansia da ospedale (HADS)
    24 Variazione dal basale nel punteggio del Questionario sulla soddisfazione del trattamento per il farmaco a 9 voci (TSQM-9
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 7, 8, 16: Weeks 1-12 and Weeks 13-24
    2, 4, 5, 6: Weeks 1-4, Weeks 1-12 and Weeks 13-24
    3: Weeks 1-2 and Weeks 13-24
    9: On the day after dosing
    10, 11, 12, 13: Baseline to Weeks 1-4 and Weeks 1-12
    14: Weeks 1-4 and Weeks 1-12
    15, 17: Week 4, Week 12 and Week 24
    18, 19, 20, 24: Baseline to Week 4, Week 12 and Week 24
    21, 22, 23: Baseline to Week 12 and Week 24
    1, 7, 8, 16: Settimane 1-12 e settimane 13-24
    2, 4, 5, 6: Settimane 1-4, settimane 1-12 e settimane 13-24
    3: Settimane 1-2 e settimane 13-24
    9: il giorno dopo l'infusione
    10, 11, 12, 13: dal basale alle settimane 1-4 e settimane 1-12
    14: settimane 1-4 e settimane 1-12
    15, 17: settimana 4, settimana 12 e settimana 24
    18, 19, 20, 24: dal basale anna settimana 4, settimana 12 e settimana 24
    21, 22, 23: dal basale alla settimana 12 e settimana 24
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    Australia
    United States
    Netherlands
    Spain
    Germany
    Italy
    Denmark
    Norway
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state96
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 475
    F.4.2.2In the whole clinical trial 570
    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
    Nessuno
    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 Opinion2022-05-24
    P. End of Trial
    P.End of Trial StatusOngoing
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