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    Summary
    EudraCT Number:2020-001969-37
    Sponsor's Protocol Code Number:19386A
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-20
    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 number2020-001969-37
    A.3Full title of the trial
    Interventional, randomized, double-blind, parallel-group, placebo-controlled delayed-start study to evaluate the efficacy and safety of eptinezumab in patients with episodic Cluster Headache
    Studio interventistico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo ad avvio ritardato per valutare l'efficacia e la sicurezza di eptinezumab in pazienti con cefalea a grappolo episodica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of eptinezumab in patients with episodic cluster headache
    Studio per valutare l’efficacia e la sicurezza di eptinezumab in pazienti con cefalea a grappolo episodica
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number19386A
    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.5.4Telephone number4536391311
    B.5.5Fax number4536301940
    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 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 nameEptinezumab
    D.3.2Product code [ALD403, Lu AG09221]
    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.3.9.1CAS number 1644539-04-7
    D.3.9.2Current sponsor codeLuAG09221
    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
    Episodic cluster headache
    Cefalea a grappolo episodica
    E.1.1.1Medical condition in easily understood language
    Recurrent severe headaches on one side of the head
    Forti mal di testa ricorrenti su un lato della testa
    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 10059133
    E.1.2Term Cluster headache
    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 purpose of this study is to evaluate the efficacy of eptinezumab in patients with episodic Cluster Headache (eCH)
    L'obiettivo di questo studio è valutare l’efficacia di eptinezumab in pazienti con cefalea a grappolo episodica (eCH)
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of eptinezumab on health-related quality of life, health care resource utilization, and work productivity
    Valutare l’efficacia di eptinezumab sulla qualità della vita correlata alla salute, sull’utilizzo delle risorse sanitarie e sulla produttività lavorativa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patient has episodic cluster headache, as defined by IHS ICHD-3 classification, with a documented history of eCH of at least 12 months prior to Screening Visit 1.
    • The patient has a prior history of cluster period(s) lasting 6 weeks or longer.
    • The patient is able to distinguish cluster headache attacks from other headaches (i.e. tension-type headaches, migraine).
    • The patient is, at Screening Visit 2, in cluster headache bout, characterized by the presence of at least one typical cluster headache attack, that started not later than 1 week prior to Screening Visit 2.
    • The patient has had a medical history of cluster headache from <=50 years of age.
    • Il paziente presenta cefalea a grappolo episodica, definita in base alla classificazione IHS ICHD-3, con anamnesi documentata di eCH di almeno 12 mesi prima della visita di screening 1.
    • Il paziente presenta una precedente anamnesi di uno o più periodi di episodi a grappolo della durata di 6 settimane o più.
    • Il paziente è in grado di distinguere attacchi di cefalea a grappolo da altri tipi di cefalea (vale a dire cefalea di tipo tensivo, emicrania).
    • Il paziente è, alla visita di screening 2, nella fase acuta di cefalea a grappolo, caratterizzata dalla presenza di almeno un attacco tipico di cefalea a grappolo, che è iniziata non oltre 1 settimana prima della visita di screening 2.
    • Il paziente presentava un’anamnesi medica di cefalea a grappolo risalente a un’età <=50 anni.
    E.4Principal exclusion criteria
    • The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway (anti-CGRP mAbs and gepants).
    • The patient has confounding and clinically significant pain syndromes (for example, fibromyalgia, complex regional pain syndrome).
    • The patient has a history or diagnosis of hypnic headache, hemicrania continua, new daily persistent headache, chronic migraine 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).
    • Patients with a lifetime history of psychosis, bipolar mania, or dementia are excluded. Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to Screening Visit 2 are also excluded.
    • The patient has attempted suicide or is, at Screening Visit 2, at significant risk of suicide.
    • The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
    • Il paziente ha manifestato fallimento in un precedente trattamento mirato al pathway del peptide correlato al gene della calcitonina (CGRP) (anticorpi monoclonali [mAb] anti-CGRP e gepanti).
    • Il paziente presenta sindromi dolorose confondenti e clinicamente significative (ad es., fibromialgia, sindrome da dolore regionale complesso).
    • Il paziente presenta un’anamnesi o una diagnosi di mal di testa ipnico, emicrania continua, nuovo mal di testa persistente quotidiano, emicrania cronica o sottotipi insoliti di emicrania quali emicrania emiplegica (sporadica e familiare), neuropatia oftalmoplegica dolorosa ricorrente, emicrania con aura troncoencefalica associata a sintomi neurologici non tipici dell’emicrania con aura (diplopia, alterazione dello stato di coscienza o di lunga durata).
    • Sono esclusi i pazienti con anamnesi di psicosi, mania bipolare o demenza nel corso della vita. Sono esclusi anche i pazienti con altre condizioni psichiatriche i cui sintomi non sono controllati o che non sono stati adeguatamente trattati per un minimo di 6 mesi prima della visita di screening 2.
    • Il paziente ha tentato il suicidio o alla visita di screening 2 è a rischio significativo di suicidio.
    • Il paziente presenta un’anamnesi di malattia cardiovascolare clinicamente significativa, tra cui ipertensione non controllata, ischemia o eventi tromboembolici (ad esempio, ictus cerebrovascolare, trombosi venosa profonda o embolia polmonare).
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline in number of weekly attacks
    1. Variazione rispetto al basale nel numero di attacchi settimanali
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Weeks 1-2
    1. Settimane 1-2
    E.5.2Secondary end point(s)
    2. Response: >= 50% reduction in number of weekly attacks
    3. Change from baseline in weekly number of times an abortive therapy was used
    4. Change from baseline in the number of daily attacks
    5. Change from baseline in weekly number of days with less than 3 attacks per day
    6. Time to resolution of cluster headache bout within 4 weeks after the first Investigational Medicinal Product (IMP) infusion
    7. Number of attacks starting within 24 hours of the start of the first infusion
    8. Change from baseline in the daily mean score on 5-point self-rating pain severity scale
    9. Change from baseline to Week 1 in number of attacks
    10. Change from baseline to Week 2 in number of attacks
    11. Response: >= 50% reduction in number of attacks in Week 1
    12. Response: >= 30% reduction in number of attacks in Week 1
    13. Response: >= 30% reduction in number of weekly attacks (Weeks 1-2)
    14. Change from baseline in weekly integrated measure of frequency and intensity of pain (Weeks 1-2): For each week add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week
    15. Change from baseline to Week 1 in integrated measure of frequency and intensity of pain: For Week 1 add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week
    16. Change from baseline to Week 2 in weekly integrated measure of frequency and intensity of pain: For Week 2 add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week
    17. Change from baseline in the number of weekly attacks
    18. Change from baseline in weekly integrated measure of frequency and intensity of pain (Weeks 1-4). For each week add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week for each attack experienced during that week.
    19. Change from baseline in the mean score on 5-point selfrating pain severity scale (average per week) for Weeks 1,2,3 and 4
    20. Change from baseline in number of attacks for Week 1,2,3 and 4
    21. Patient Global Impression of Change (PGIC) score at Week 1,2 and 4
    22. Change from baseline in Sleep Impact Scale (SIS) score at Weeks 2 and 4
    23. Change from baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) at Week 2 and 4
    24. Change from baseline in Health Care Resources Utilization (HCRU) at Week 4
    25. Change from baseline in the Work Productivity Activity Questionnaire at Week 4. General Health second version (WPAI:GH2.0) subscores (Absenteeism, Presenteeism, Work productivity loss, Activity impairment)
    2. Risposta: riduzione >=50% nel numero di attacchi settimanali
    3. Variazione rispetto al basale del numero di volte a settimana in cui è stata utilizzata una terapia abortiva
    4. Variazione rispetto al basale del numero di attacchi giornalieri
    5. Variazione rispetto al basale nel numero di giorni a settimana con meno di 3 attacchi al giorno
    6. Tempo alla risoluzione della fase acuta di cefalea a grappolo entro 4 settimane dopo la prima infusione del prodotto medicinale sperimentale (IMP)
    7. Numero di attacchi che iniziano entro 24 ore dall’inizio della prima infusione
    8. Variazione rispetto al basale nel punteggio medio giornaliero sulla scala di autovalutazione della gravità del dolore a 5 punti
    9. Variazione dal basale alla Settimana 1 nel numero di attacchi
    10. Variazione dal basale alla Settimana 2 nel numero di attacchi
    11. Risposta: riduzione >=50% nel numero di attacchi nella Settimana 1
    12. Risposta: riduzione >=30% nel numero di attacchi nella Settimana 1
    13. Risposta: riduzione >=30% nel numero di attacchi settimanali (Settimane 1-2)
    14. Variazione rispetto al basale nella misura settimanale integrata della frequenza e dell’intensità del dolore (Settimane 1-2): per ogni settimana, aggiungere l’intensità (dolore peggiore sulla scala di autovalutazione della gravità del dolore a 5 punti) per ogni attacco manifestato durante quella settimana.
    15. Variazione dal basale alla Settimana 1 nella misura integrata della frequenza e dell’intensità del dolore: per la Settimana 1, aggiungere l’intensità (dolore peggiore sulla scala di autovalutazione della gravità del dolore a 5 punti) per ogni attacco manifestato durante quella settimana.
    16. Variazione dal basale alla Settimana 2 nella misura settimanale integrata della frequenza e dell’intensità del dolore: per la Settimana 2, aggiungere l’intensità (dolore peggiore sulla scala di autovalutazione della gravità del dolore a 5 punti) per ogni attacco manifestato durante quella settimana.
    17. Variazione rispetto al basale nel numero di attacchi settimanali
    18. Variazione rispetto al basale nella misura settimanale integrata della frequenza e dell’intensità del dolore (Settimane 1-4): per ogni settimana, aggiungere l’intensità (dolore peggiore sulla scala di autovalutazione della gravità del dolore a 5 punti) per ogni attacco manifestato durante quella settimana.
    19. Variazione rispetto al basale nel punteggio medio sulla scala di autovalutazione della gravità del dolore a 5 punti (media alla settimana) per le Settimane 1, 2, 3 e 4
    20. Variazione rispetto al basale nel numero di attacchi per le Settimane 1, 2, 3 e 4
    21. Punteggio dell’Impressione globale del paziente sul cambiamento (PGIC) alle Settimane 1, 2 e 4
    22. Variazione rispetto al basale nel punteggio della Scala di valutazione dell’impatto del sonno (SIS) alle Settimane 2 e 4
    23. Variazione rispetto al basale nel Questionario europeo sulla qualità della vita a 5 dimensioni e 5 livelli (EQ-5D-5L) alle Settimane 2 e 4
    24. Variazione rispetto al basale nell’Utilizzo delle risorse sanitarie (HCRU) alla Settimana 4
    25. Variazione rispetto al basale nei sottopunteggi del Questionario sulla compromissione della produttività lavorativa e delle attività: Salute generale, seconda versione (WPAI:GH2.0) (Assenteismo, Presenteismo, Perdita della produttività lavorativa, Compromissione delle attività) alla Settimana 4
    E.5.2.1Timepoint(s) of evaluation of this end point
    2. Weeks 1-2
    3. Weeks 1-2
    4. Days 1-3
    5. Weeks 1-2
    6. From baseline to Week 4
    7. From first infusion to 24-hours post dose
    8. Days 1-3
    9. From baseline to Week 1
    10. From baseline to Week 2
    11. Week 1
    12. Week 1
    13. Weeks 1-2
    14. Weeks 1-2
    15. Week 1
    16. Week 2
    17. Weeks 1-4
    18. Weeks 1-4
    19. Weeks 1, 2, 3 and 4
    20. Weeks 1, 2, 3 and 4
    21. Weeks 1, 2 and 4
    22. Weeks 2 and 4
    23. Weeks 2 and 4
    24. Week 4
    25. Week 4
    2. Settimane 1-2
    3. Settimane 1-2
    4. Giorni 1-3
    5. Settimane 1-2
    6. Dal basale alla settimana 4
    7. Dalla prima infusione a 24 ore dopo la dose
    8. Giorni 1-3
    9. Dal basale alla Settimana 1
    10. Dal basale alla Settimana 2
    11. Settimana 1
    12. Settimana 1
    13. Settimane 1-2
    14. Settimane 1-2
    15. Settimana 1
    16. Settimana 2
    17. Settimane 1-4
    18. Settimane 1-4
    19. Settimane 1, 2, 3 e 4
    20. Settimane 1, 2, 3 e 4
    21. Settimane 1, 2 e 4
    22. Settimane 2 e 4
    23. Settimane 2 e 4
    24. Settimana 4
    25. Settimana 4
    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 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) 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA86
    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
    Georgia
    Russian Federation
    United States
    Belgium
    Denmark
    Estonia
    Finland
    France
    Germany
    Greece
    Italy
    Netherlands
    Norway
    Portugal
    Spain
    Sweden
    United Kingdom
    Czechia
    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 months7
    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 months7
    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: 295
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 304
    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 Decision2021-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-19
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