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    Summary
    EudraCT Number:2020-005310-17
    Sponsor's Protocol Code Number:CAMG334AIT05T
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-04
    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 number2020-005310-17
    A.3Full title of the trial
    MicroRNA profile in women with migraine before and after treatment with erenumab
    Profilo di espressione dei microRNA nelle donne con emicrania prima e dopo trattamento con erenumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Small particles of genetic material in the blood of women with migraine before and after treatment with the drug erenumab
    Frammenti di materiale genetico reperiti nel sangue di donne con emicrania prima e dopo il trattamento con il farmaco erenumab
    A.3.2Name or abbreviated title of the trial where available
    MicroRNAs and erenumab
    MicroRNA e terapia con erenumab
    A.4.1Sponsor's protocol code numberCAMG334AIT05T
    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 SponsorASL 1 AVEZZANO-SULMONA-L'AQUILA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Farma
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASL 1 Avezzano-Sulmona-L'Aquila
    B.5.2Functional name of contact pointUnità Operativa Complessa di Neurol
    B.5.3 Address:
    B.5.3.1Street AddressVia Giuseppe di Vittorio snc
    B.5.3.2Town/ cityAvezzano
    B.5.3.3Post code67059
    B.5.3.4CountryItaly
    B.5.6E-mailneurologiaaz@asl1abruzzo.it
    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.2.5The 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 nameAimovig
    D.3.2Product code [AMG334]
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1582205-90-0
    D.3.9.2Current sponsor codeAMG334
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 Yes
    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
    Episodic or chronic migraine
    Emicrania episodica o cronica
    E.1.1.1Medical condition in easily understood language
    Frequent headache
    Mal di testa frequente
    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 investigate how the migraine-associated microRNA expression is modulated by treatment with erenumab.
    Studiare come l'espressione dei miRNA associati all'emicrania viene modulata dal trattamento con erenumab.
    E.2.2Secondary objectives of the trial
    1) To compare the expression profile of microRNAs in patients with episodic and chronic migraine.
    2) To investigate differences in migraine-associated microRNA expression according to age, migraine characteristics, response to erenumab, and migraine-related impact and disability.
    1) Confrontare il profilo di espressione dei miRNA nelle pazienti con emicrania episodica con quello delle pazienti con emicrania cronica.
    2) Studiare le differenze nell'espressione dei microRNA associati all'emicrania in base all'età, alle caratteristiche dell'emicrania, alla risposta a erenumab e all'impatto e alla disabilità correlati all'emicrania.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for inclusion in this study must meet all of the following criteria:
    1. Women aged 25 to 50 years
    2. Provided informed consent
    3. EM or CM migraine with or without aura
    4. At least 1 year from migraine onset
    5. Clinical indication to treatment with erenumab according to the Summary of Product Characteristics and local reimbursement criteria.
    I soggetti ammessi a essere inclusi in questo studio devono soddisfare tutti i seguenti criteri:
    1. Donne dai 25 ai 50 anni
    2. Consenso informato
    3. Emicrania episodica o cronica con o senza aura
    4. Almeno 1 anno dall'esordio dell'emicrania
    5. Indicazione clinica al trattamento con erenumab secondo il Riassunto delle Caratteristiche del Prodotto e i criteri di rimborso locali.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria are not eligible for inclusion in this study.
    1. Headache other than migraine
    2. Prior exposure to erenumab or other monoclonal antibodies targeting CGRP or its receptor
    3. Use of any migraine preventive treatment in the last 60 days or 5 half-lives or 4 months if ever treated with botulinum toxin A
    4. Pregnant or nursing
    5. Body Mass Index <18 or >30 Kg/m2
    6. Heavy smoking (more than 20 cigarettes per day)
    7. Myocardial infarction, stroke, transient ischemic attack, unstable angina, or coronary artery bypass surgery or other revascularization procedures within 12 months prior to first visit
    8. Illicit drug abuse
    9. Major psychiatric disorders
    10. Infective or inflammatory diseases
    11. Preventive treatments in the last 3 months
    12. Any chronic medication prescribed for indications different from migraine within 60 days before study initiation
    I soggetti che soddisfano uno dei seguenti criteri non possono essere inclusi in questo studio.
    1. Cefalea non emicranica
    2. Precedenti esposizioni a erenumab o altri anticorpi monoclonali diretti contro il CGRP o il suo recettore
    3. Uso di qualsiasi trattamento preventivo di emicrania negli ultimi 60 giorni o 5 emivite o 4 mesi nel caso della tossina botulinica di tipo A
    4. Gravidanza o allattamento
    5. Indice di massa corporea <18 o> 30 Kg/m2
    6. Fumo (più di 20 sigarette al giorno)
    7. Infarto miocardico, ictus, attacco ischemico transitorio, angina instabile o intervento chirurgico di bypass dell'arteria coronarica o altre procedure di rivascolarizzazione entro 12 mesi prima della prima visita di studio
    8. Abuso di droghe
    9. Disturbi psichiatrici maggiori
    10. Malattie infettive o infiammatorie
    11. Trattamenti preventivi per emicrania negli ultimi 3 mesi
    12. Qualsiasi farmaco cronico prescritto per indicazioni diverse dall'emicrania entro 60 giorni prima dell'inizio dello studio
    E.5 End points
    E.5.1Primary end point(s)
    Relative quantification of circulating microRNAs expression changes in women with episodic and chronic migraine before (T0) and after a 3-month (T1) treatment with erenumab.
    Quantificazione relativa delle variazioni nell'espressione dei miRNA circolanti nelle donne con emicrania episodica e cronica prima (T0) e dopo un trattamento di 3 mesi (T1) con erenumab.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi
    E.5.2Secondary end point(s)
    Relative expression profiling of selected microRNAs at baseline in women with chronic migraine compared with episodic migraine; Subgroup analysis of primary endpoint stratified according to age, migraine characteristics, response to erenumab, migraine impact and related disability
    Profilazione dell'espressione relativa di microRNA selezionati al basale nelle donne con emicrania cronica rispetto a quelle con emicrania episodica; Analisi di sottogruppo dell'endpoint primario in base all'età, alle caratteristiche dell'emicrania, alla risposta a erenumab e all'impatto e alla disabilità correlati all'emicrania
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months; 3 months
    3 mesi; 3 mesi
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Studio genetico
    Genetic study
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    The trial will come to an end when all the expected recruited subjects (40) have completed the 14-week follow-up.
    La sperimentazione sarà conclusa quando il numero atteso di soggetti (40) avrà completato le 14 settimane di osservazione previste.
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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 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: 40
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 will be treated according to normal clinical practice
    Le pazienti saranno trattate secondo la normale pratica clinica
    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 Decision2021-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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