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    Summary
    EudraCT Number:2020-001968-28
    Sponsor's Protocol Code Number:19385A
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-23
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-001968-28
    A.3Full title of the trial
    Interventional, open-label, fixed-dose multiple administration study to evaluate long-term treatment with eptinezumab in patients with chronic cluster headache
    Estudio de intervención, abierto, de administración múltiple en dosis fijas, para evaluar el tratamiento a largo plazo con eptinezumab en pacientes con cefalea en brotes crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 1-year Study to Inform About Long-term Exposure to Eptinezumab in Patients With Chronic Cluster Headache (cCH)
    Estudio de 1 año para informar sobre la exposición a largo plazo a eptinezumab en pacientes con cefalea en brotes crónica (CBC)
    A.3.2Name or abbreviated title of the trial where available
    CHRONICLE
    A.4.1Sponsor's protocol code number19385A
    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.3.4Pharmaceutical 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 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 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
    Chronic cluster headache
    Cefalea en brotes crónica
    E.1.1.1Medical condition in easily understood language
    Severe headaches on one side of the head
    Fuertes dolores de cabeza en un lado de la cabeza
    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 24.0
    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 main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.
    El principal objetivo the este ensayo es informar acerca de la seguridad y tolerabilidad a largo plazo de eptinezumab en pacientes con cefalea en brotes crónica.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of eptinezumab in patients with cCH
    Evaluar la eficacia de eptinezumab en pacientes con CBc.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    * The participant has a diagnosis of cCH as defined by International Headache Society (IHS) International
    Classification of Headache Disorders third edition (ICHD-3) classification with a history of cCH of at least 12 months prior to the Screening Visit.
    * The participant has had a diagnosis of cluster headache at <50 years of age.
    * The participant has an adequately documented record of previous abortive, transitional and preventive medication use for cCH, for at least 12 months prior to the Screening Visit.
    * The participant is able to distinguish cluster headache attacks from other headaches (such as tension-type headaches, migraine).
    - El paciente presenta un diagnóstico de CBc según la definición de clasificación de la ICHD-3 publicada por la IHS, con antecedentes de CBc durante un mínimo de 12 meses antes de la visita de selección.
    - El paciente ha tenido un diagnóstico de cefalea en brotes desde que tenía <50 años de edad.
    - El paciente presenta un registro documentado adecuadamente de uso previo de medicación abortiva, transicional y preventiva para la CBc durante al menos 12 meses antes de la visita de selección.
    - El paciente puede distinguir los episodios de cefalea en brotes de otras cefaleas (como cefaleas de tipo tensional, migraña).
    E.4Principal exclusion criteria
    * The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway (anti-CGRP monoclonal antibodies [mAbs] and gepants).
    * The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, complex regional pain syndrome).
    * The participant has a history or diagnosis of chronic tension-type headache, 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 neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or longer than 1 hour).
    * Participants with a lifetime history of psychosis, bipolar mania, or dementia. Participants 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.
    * The participant has attempted suicide or is, at Screening Visit, at significant risk of suicide.
    * 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).
    - El paciente presenta fracaso terapéutico previo con un fármaco dirigido a la vía del CGRP (anticuerpos monoclonales [Acm] y gepantes anti-CGRP).
    - El paciente presenta síndromes de dolor clínicamente significativos que puedan actuar como factores de confusión (por ejemplo, fibromialgia, síndrome de dolor regional complejo).
    - El paciente presenta antecedentes o diagnóstico de cefalea de tipo tensional crónica, cefalea hípnica, hemicránea continua, cefalea diaria persistente de novo, migraña crónica o subtipos inusuales de migraña como la migraña hemipléjica (esporádica y familiar), la neuropatía oftalmopléjica dolorosa recurrente, la migraña con manifestaciones neurológicas concurrentes que no son típicas del aura migrañosa (diplopía, alteración de la conciencia o una duración superior a 1 hora).
    - Pacientes con antecedentes de psicosis, manía bipolar o demencia. También quedan excluidos los pacientes con otras afecciones psiquiátricas cuyos síntomas no estén controlados o que no hayan sido tratados adecuadamente durante un mínimo de 6 meses antes de la visita de selección.
    - El paciente ha intentado suicidarse o está, en la visita de selección, en riesgo significativo de suicidio.
    - El paciente presenta antecedentes de enfermedad cardiovascular clínicamente significativa, incluidas la hipertensión no controlada, la isquemia vascular o los acontecimientos tromboembólicos (por ejemplo, accidente cerebrovascular, trombosis venosa profunda o embolia pulmonar).
    E.5 End points
    E.5.1Primary end point(s)
    Number of Participants With Adverse Events
    Número de pacientes con acontecimientos adversos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
    Desde el día de la primera dosis del fármaco del estudio (Inicio [semana 0]) hasta la semana 56
    E.5.2Secondary end point(s)
    1. Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache: Number of Participants With No Cluster Headache Attacks for ≥3 Consecutive Months (≥13 Consecutive Weeks)
    2. Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used, Averaged Over the First 4 Weeks After Each Infusion
    3. Change From Baseline in the Average Number of Weekly Attacks, Averaged Over the First 4 Weeks After Each Infusion
    4. Change From Baseline in the 5-Point Self-Rating Pain Severity Scale, Averaged Over the First 4 Weeks After Each Infusion
    5. Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Averaged Over the First 4 Weeks After Each Infusion
    6. Response: Number of Participants With ≥50% Reduction From Baseline inNumber of Weekly Attacks Averaged Over the First 4 Weeks After Each Infusion
    7. cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks)
    8. cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks Between the First and Second Infusion)
    9. cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks Between the Second and Third Infusion)
    10. cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks Between the Third and Fourth Infusion)
    11. cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion)
    12. Number of Participants who Received a Transitional Therapy During the Treatment Period
    13. Patient Global Impression of Change (PGIC) Score
    14. Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
    15. Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
    16. Health Care Resources Utilization (HCRU) Score
    17. Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
    1. Conversión de cefalea en brotes crónica (CBc) a cefalea en brotes episódica: Número de pacientes sin episodios de cefalea en brotes durante ≥3 meses consecutivos (≥13 semanas consecutivas).
    2. Cambio con respecto al inicio en el número semanal de veces que se utilizó un tratamiento abortivo (oxígeno y/o triptanos) tomando el promedio de las 4 primeras semanas después de cada infusión.
    3. Cambio con respecto al inicio en el número medio de episodios semanales, tomando el promedio en las 4 primeras semanas después de cada infusión.
    4. Cambio con respecto al inicio en la escala de autovaloración de la intensidad del dolor de 5 puntos, tomando el promedio en las 4 primeras semanas después de cada infusión.
    5. Respuesta: número de pacientes con reducción de ≥30 % en el número medio de episodios semanales, tomando el promedio en las 4 primeras semanas después de cada infusión.
    6. Respuesta: número de pacientes con reducción de ≥50 % en el número medio de episodios semanales, tomando el promedio en las 4 primeras semanas después de cada infusión.
    7. Remisión de la CBc: número de pacientes sin episodios de cefalea en brotes durante ≥1 mes (5 semanas consecutivas).
    8. Remisión de la CBc número de pacientes sin episodios de cefalea en brotes durante ≥1 mes (5 semanas consecutivas entre la primera y la segunda infusión)
    9. Remisión de la CBc (número de pacientes sin episodios de cefalea en brotes durante ≥1 mes (5 semanas consecutivas entre la segunda y la tercera infusión).
    10. Remisión de la CBc número de pacientes sin episodios de cefalea en brotes durante ≥1 mes (5 semanas consecutivas entre la tercera y la cuarta infusión).
    11. Remisión de la CBc número de pacientes sin episodios de cefalea en brotes durante ≥1 mes (5 semanas consecutivas en las primeras 12 semanas después de la cuarta infusión).
    12. Número de pacientes que recibieron un tratamiento de transición durante el período de tratamiento
    13. Puntuación de la Impresión global del cambio por parte del paciente (Patient Global Impression of Change, PGIC)
    14. Cambio con respecto al inicio en las puntuaciones de los dominios de la Escala de impacto del sueño (Sleep Impact Scale, SIS) a lo largo del tiempo
    15. Cambio con respecto al inicio en el cuestionario EuroQol de 5 dimensiones y 5 niveles (EQ-5D-5L) en las semanas 4, 16, 28, 40 y 48.
    16. Utilización de recursos sanitarios (URS)
    17. Cambio con respecto al inicio en las subpuntuaciones de la segunda versión del Cuestionario de productividad laboral y deterioro de las actividades: salud general (WPAI:GH2.0) (absentismo, presentismo, pérdida de productividad laboral, deterioro de las actividades) en las semanas 4, 16, 28, 40 y 48.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline (Week 0) to Week 48
    2. Baseline (Week 0), Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
    3. Baseline (Week 0), Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
    4. Baseline (Week 0), Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
    5. Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
    6. Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
    7. Baseline (Week 0) to Week 48
    8. Baseline (Week 0) to Week 12
    9. Week 12 to Week 24
    10. Week 24 to Week 36
    11. Week 36 to Week 48
    12. Week 0 to Week 48
    13. Baseline (Week 0) up to Week 48
    14. Baseline (Week 0) up to Week 40
    15. Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48
    16. Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48
    17. Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48
    1. Inicio (Semana 0) a semana 48
    2. Inicio (Semana 0), Semanas 1 a 4, 13 a 16, 25 a 28, y 37 a 40
    3. Inicio (Semana 0), Semanas 1 a 4, 13 a 16, 25 a 28, y 37 a 40
    4. Inicio (Semana 0), Semanas 1 a 4, 13 a 16, 25 a 28, y 37 a 40
    5. Semanas 1 a 4, 13 a 16, 25 a 28, y 37 to 40
    6. Semanas 1 a 4, 13 a 16, 25 a 28, y 37 a 40
    7. Inicio (Semana 0) a semana 48
    8. Inicio (Semana 0) a semana 12
    9. Semana 12 a semana 24
    10. Semana 24 a semana 36
    11. Semana 36 a semana 48
    12. Semana 0 a semana 48
    13. Inicio (Semana 0) hasta la semana 48
    14. Inicio (Semana 0) hasta la semana 40
    15. Inicio (Semana 0), Semanas 1 a 4, 16, 28, 40 y 48
    16. Inicio (Semana 0), Semanas 1 a 4, 16, 28, 40 y 48
    17. Inicio (Semana 0), Semanas 1 a 4, 16, 28, 40 y 48
    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 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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    United States
    Denmark
    Finland
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days24
    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: 93
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 125
    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
    Ninguno
    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 Decision2021-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-07
    P. End of Trial
    P.End of Trial StatusOngoing
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