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    Summary
    EudraCT Number:2021-006219-28
    Sponsor's Protocol Code Number:MRSI
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-14
    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 ConcernedAustria - BASG
    A.2EudraCT number2021-006219-28
    A.3Full title of the trial
    MR-Spectroscopy: Investigating neurochemical changes in brain metabolism in migraineurs before and after CGRPAntibody treatment – a randomized, controlled, open-label trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MR-Spectroscopy Study: Investigating changes in brain metabolism in migraine patients before and after therapeutic influence
    A.4.1Sponsor's protocol code numberMRSI
    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 SponsorMedical University Innsbruck
    B.1.3.4CountryAustria
    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 supportTEVA
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniv. Clinic Innsbruck, Department of Neurology
    B.5.2Functional name of contact pointKopfschmerzambulanz
    B.5.3 Address:
    B.5.3.1Street AddressAnichstr. 35
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.6E-mailvera.filippi@student.i-med.ac.at
    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 Ajovy
    D.2.1.1.2Name of the Marketing Authorisation holderTeva
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAjovy
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.8INN - Proposed INNFremanezumab
    D.3.9.1CAS number 1655501-53-3
    D.3.9.4EV Substance CodeSUB186896
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number225
    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 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 migraine
    E.1.1.1Medical condition in easily understood language
    Episodic migraine
    E.1.1.2Therapeutic area Not possible to specify
    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
    To investigate whether CGRP-antibody treatment (Fremanezumab 225mg monthly) leads to neurochemical changes in the occipital cortex and the
    thalamus of patients with migraine with and without aura.
    E.2.2Secondary objectives of the trial
    To identify possible correlations between disease severity, headache frequency and measured metabolic markers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent must be obtained before any assessment is performed
    • Adults > 18 and < 65 of age upon entry into screening
    • Documented history of migraine with or without aura >12 months prior to screening according to the International Classification of Headache
    Disorders-3rd Edition (ICHD-3)
    • Migraine frequency ≥ 1 and ≤ 15 migraine days per month across the 3 months prior to screening based on retrospective reporting.
    • Subject has not received a CGRP mAB for migraine prophylaxis in the past.
    • Subject can differentiate migraine from other headaches
    • Lack of contraindication for MRI
    E.4Principal exclusion criteria
    • Older than 50 years of age at migraine onset.
    • History of cluster headache or hemiplegic migraine headache
    • Unable to differentiate migraine from other headaches.
    • Exposure to botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline period, during the baseline period, or
    treatment period.
    • Traditional medications and/or procedures are not allowed if not used at a stable dose/frequency for at least 3 months prior to randomization and
    during the study.
    • Active chronic pain syndromes (e.g., fibromyalgia, chronic pelvic pain).
    • History of major psychiatric disorders (such as schizophrenia or bipolar disorder) or current evidence of depression.
    • History of seizure disorder or other significant neurological conditions other than migraine.
    • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated,
    within the past 5 years
    • Human immunodeficiency virus (HIV) infection by history.
    • History or evidence of any other unstable or clinically significant medical condition.
    • Subject has any clinically significant vital sign during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation.
    • Coronary artery disease, myocardial infarction, stroke, transient ischemic attack, stable or unstable angina pectoris, carotid or vertebro-basilar
    artery disease, other cerebrovascular conditions (e.g.: AV malformation, aneurysm)
    • Evidence of drug or alcohol abuse or dependence in the past, based on medical records, patient self-report.
    • Pregnant or nursing (lactating) women
    • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of
    contraception during dosing with study treatment.
    • Use of other investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline,
    whichever is longer.
    • History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
    • Previous exposure to Fremanezumab 225mg monthly or 675mg quarterly or exposure to any other prophylactic CGRP-targeted therapy (prior to and
    during the study).
    • Unlikely to be able to complete all protocol required study procedures to the best of the subject’s and investigator’s knowledge
    • Taken the following for any indication during 2 months prior to screening:
    -Ergotamines or triptans on ≥10 days per month, or
    -NSAIDs, acetaminophen on ≥15 days per month, or
    -Opioid-containing analgesics on ≥4 days per month
    E.5 End points
    E.5.1Primary end point(s)
    Neurochemical changes in the brain metabolism before and after CGRP antibody treatment can be detected
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the second MRSI has been conducted for each patient
    E.5.2Secondary end point(s)
    Correlations between disease severity, headache frequency and measured metabolic markers can be observed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the second MRSI has been conducted for each patient
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To investigate whether CGRP-antibody treatment leads to neurochemical changes visible in MRSI in the occipital cortex and the thalamus of patients with migraine with and without aura.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    The control group does not get any medication or placebo.
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The 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 No
    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 study ends after the conduction of the second MRSI for the last patient enrolled in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    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: 38
    F.1.3Elderly (>=65 years) No
    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 state38
    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)
    If desired, patients will continue to be treated in the headache outpatient clinic of the University Clinic for Neurology. Treatment or care do not differ from the expected normal treatment of that condition.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Medical University Innsbruck
    G.4.3.4Network Country Austria
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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