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    Summary
    EudraCT Number:2019-004497-25
    Sponsor's Protocol Code Number:18898A
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-14
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-004497-25
    A.3Full title of the trial
    Interventional, randomized, double-blind, parallel-group, placebo-controlled study with an extension period to evaluate the efficacy and safety of eptinezumab for the prevention of migraine in patients with unsuccessful prior preventive treatments
    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 for the Prevention of Migraine in Patients That Are Not Helped by Previous Preventive Treatments
    A.3.2Name or abbreviated title of the trial where available
    Deliver
    A.4.1Sponsor's protocol code number18898A
    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 number+4536301311
    B.5.5Fax number+45 36301940
    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
    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 in patients with unsuccessful prior preventive treatments
    E.1.1.1Medical condition in easily understood language
    Migraine
    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 evaluate the efficacy of eptinezumab for the prevention of migraine in patients with unsuccessful prior preventive treatments
    E.2.2Secondary objectives of the trial
    • To evaluate the health-related quality of life and work productivity impact of eptinezumab
    • To evaluate the effect of long-term treatment with eptinezumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patient has a diagnosis of migraine, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit.
    • The patient has a migraine onset of ≤50 years of age.
    • The patient has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
    • The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
    • The patient fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period:
    – For patients with CM: Migraine occurring on ≥8 days and headache occurring on >14 days
    – For patients with EM: Migraine occurring on ≥4 days and headache occurring on ≤14 days
    • The patient has documented evidence of treatment failure (must be supported by medical record or by physician’s confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications.
    • The patient has a history of either previous or active use of triptans for migraine.
    • The patient is aged ≥18 and ≤75 years at the Screening Visit.

    Other inclusion criteria may apply.
    E.4Principal exclusion criteria
    • The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
    • The patient has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications.
    • The patient has confounding and clinically significant pain syndromes, (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
    • The patient has a diagnosis of acute or active temporomandibular disorder.
    • The patient 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), ophthalmoplegic migraine, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
    • The patient has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Patients with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded.
    • The patient has a history of clinically significant cardiovascular disease or vascular ischaemia or thromboembolic events (e.g. cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

    Other exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline in the number of monthly migraine days
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. [Time Frame: From Baseline to Weeks 1-12]
    E.5.2Secondary end point(s)
    2. Response: patients with 50% reduction from baseline in monthly migraine days
    3. Change from baseline in the number of monthly migraine days
    4. Response: patients with 75% reduction from baseline in monthly migraine days
    5. Response: patients with 100% reduction from baseline in monthly migraine days
    6. Response: patients with 50% reduction from baseline in monthly headache days
    7. Response: patients with 75% reduction from baseline in monthly headache days
    8. Response: patients with 100% reduction from baseline in monthly headache days
    9. Change from baseline in the number of monthly headache days
    10. Migraine/headaches with severe pain intensity
    11. Change from baseline in the number of monthly migraine days with use of acute medication
    12. Patient Global Impression of Change (PGIC) score. The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse)
    13. Change from baseline in the number of monthly migraine days in patients with Medication Overuse Headache (MOH)
    14. Number of Patients with a migraine on the day after first dosing
    15. Change in Most Bothersome Symptom (MBS) score. Patients will identify a migraine-related symptom that is most bothersome for them. Patients will be asked to rate the improvement in this symptom from screening on a 7-point scale. The pre-specified bothersome items are: nausea, vomiting, sensitivity to light, sensitivity with sound
    16. Change from baseline in the Headache Impact Test (HIT-6) score
    17. Change from baseline in the Migraine-Specific Quality of Life (MSQ v. 2.1) sub-scores
    Sub-scores: Role Function-Restrictive, Role Function-Preventive, Emotional Function)
    18. Change from baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score
    19. Change from baseline in Health Care Resources Utilisation (HCRU) score
    20. Change from baseline in work productivity as measured using the Work Productivity and Activity Impairment Questionnaire (WPAI) sub-scores
    Sub-scores: (Absenteeism, Presenteeism, Work productivity loss, Activity impairment)
    E.5.2.1Timepoint(s) of evaluation of this end point
    2. [Time Frame: From Baseline to Weeks 1-12, Weeks 13-24, Weeks 25-36, Weeks 37-48, Weeks 49-60, Weeks 61-72]
    3. [Time Frame: From Baseline to Weeks 13-24, Weeks 25-36, Weeks 37-48, Weeks 49-60, Weeks 61-72]
    4. [Time Frame: From Baseline to Weeks 1-12, Weeks 13-24, Weeks 25-36, Weeks 37-48, Weeks 49-60, Weeks 61-72]
    5, 6, 7, 8, 9, 10, 13, 15. [Time Frame: From Baseline to Weeks 1-12]
    11. [Time Frame: From Baseline to Weeks 1-12, Weeks 13-24]
    12. [Time Frame: At Week 12 and at Week 24]
    14. [Time Frame: On the day after first dosing]
    16. [Time Frame: From Baseline to Week 12 and from baseline to Week 24, at Weeks 36, 48, 60, and 72]
    17, 18, 19, 20. [Time Frame: From Baseline to Week 12, from Baseline to Week 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) 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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Finland
    France
    Poland
    Sweden
    Bulgaria
    Spain
    Czechia
    Germany
    Italy
    Belgium
    Denmark
    Georgia
    Hungary
    Russian Federation
    Slovakia
    United Kingdom
    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 overall end of the study is defined as the last protocol-specified contact with the last patient ongoing in the study.
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 715
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 state305
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 710
    F.4.2.2In the whole clinical trial 840
    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 in the study will have access to appropriate medical care after they complete or withdraw from the study.
    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 Decision2020-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-23
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    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
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