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    Summary
    EudraCT Number:2021-006176-16
    Sponsor's Protocol Code Number:I5Q-NS-O001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-04
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-006176-16
    A.3Full title of the trial
    Definition of neuroimaging and laboratory biomarkers as possible predictors for treatment response to Galcanezumab in high-frequency episodic migraine (PREDICT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with the objective to find in patients with high-frequency episodic migraine (patients with 8-14 migraine days/months) signs on head MRI (=neuroimaging biomarkers) and indicators from blood and tear fluid (=laboratory biomarkers) which are linked to a good efficacy of a medication named Galcanezumab
    A.3.2Name or abbreviated title of the trial where available
    PREDICT
    A.4.1Sponsor's protocol code numberI5Q-NS-O001
    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 SponsorCharité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportLilly Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointStudy Physician
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.6E-mailpredict@charite.de
    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 Emgality
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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
    High-frequency episodic migraine.
    E.1.1.1Medical condition in easily understood language
    Migraine occuring on 8-14 days per month. Migraine is moderate to severe, often one-sided and pulsatile headache lasting 4-72h, accompagnied by nausea, vomiting and/or sensitivity to light and sound.
    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 22.0
    E.1.2Level LLT
    E.1.2Classification code 10082019
    E.1.2Term Episodic migraine
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the hypothesis that a 3 months treatment with Galcanezumab results in structural and functional brain alterations and changes of CGRP blood levels in patients with high-frequency episodic migraine.
    The purpose of this study is to identify structural and functional neuroimaging and laboratory biomarkers (CGRP / PACAP, immune cell populations) that are altered in association with treatment with Galcanezumab in patients with high frequency episodic migraine. Data from this study will provide information on neuroimaging and blood markers that may help to identify patients who benefit from a prophylactic treatment with Galcanezumab.
    E.2.2Secondary objectives of the trial
    1. To evaluate if neuroimaging and blood markers alterations in patients with high-frequency episodic migraine treated with Galcanezumab differ between treatment responders and non-responders (≥50% Response vs. <50% Response)
    2. To evaluate if changes of neuroimaging and blood biomarkers in patients with high-frequency episodic migraine correlate with changes of monthly migraine days in response to treatment with Galcanezumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Screening:
    • Adults ≥18 and ≤ 65 years of age upon entry into screening
    • Diagnosis of episodic migraine according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (21) with a history of migraine headaches of at least 1 year prior to Visit 1
    • History of episodic migraine with 8-14 migraine days / month on average within the past 3 months
    • Migraine onset prior to age 50
    • Capability of understanding the nature, significance and implications of the clinical trial. Written informed consent must be obtained before any assessment is performed
    • Reliable and willing to follow study procedures
    • Valid health insurance (to assure medical clarification in case of incidental findings on MRI)
    During Baseline:
    • This inclusion criterion should not be shared with potential patients: 8-14 migraine days / month during baseline (-30 days before first treatment)
    E.4Principal exclusion criteria
    • Current participation or participation within the last 30 days or within 5 half-lives (whichever is longer) in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
    • Current use of a prohibited treatment (pharmaceutical or neurostimulation) for the prevention of migraine
    • Current use of an effective and well tolerated treatment (pharmaceutical or neurostimulation) for the prevention of migraine. Insufficient efficacy and tolerability as determined by the patient
    • Current use or prior exposure to any CGRP (receptor) antibody
    • Diagnosis or history of other primary headache diseases according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), except for episodic tension-type headache
    • Systemic or metabolic disorder including high blood pressure severe hypertension (not medically controlled or taking more than one drug class for treatment, diabetes mellitus, or hypercholesterolemia (not controlled by medical treatment and/or diet)
    • History or current severe coronary artery disease, myocardial infarction, stroke, transient ischemic attack, unstable angina, deep vein thrombosis, coronary artery bypass surgery or other revascularization procedures within 12 months prior to screening
    • Planned cardiovascular surgery or percutaneous coronary angioplasty
    • History or presence of any other medical illness including but not limited to any autoimmune disorder, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality, that in the judgment of the investigator, indicates a medical problem that would preclude study participation.
    • Psychiatric disease besides stable panic disorder or depression (not more than one 1 medication and no increase in dosage or restarting of treatment within the 3 months prior to the start of the baseline phase)
    • History of drug or alcohol abuse/dependence within 1 year prior to inclusion
    • Pregnancy / planned pregnancy, nursing patients
    • Contraindication for MRI
    • Radiological exclusion criteria: ischemic or hemorrhagic lesions, tumor, and intracranial cyst
    E.5 End points
    E.5.1Primary end point(s)
    Functional brain alterations (rs-fMRI) after 3 months treatment with Galcanezumab in patients with high-frequency episodic migraine
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12/month 3
    E.5.2Secondary end point(s)
    1) Structural brain alterations (VBM, DTI) after 3 months treatment with Galcanezumab
    2) Mean CGRP (calcitonin gene-related peptide) plasma and tear fluid concentrations after 3 months treatment with Galcanezumab
    3) Structural and functional brain alterations at baseline and after 3 months treatment in responders (reduction from baseline ≥50% in monthly migraine days in month 3) in comparison to non-responders (reduction from baseline <50% in monthly migraine days in month 3)
    4) Mean concentrations of CGRP and PACAP (calcitonin gene-related peptide) at baseline and month 3 in responders in comparison to non-responders
    5) Peripheral immune cell subpopulations and levels of cytokines (IL-1β, IL-6, TNF-α) at baseline and after the 3 months treatment
    6) Structural and functional brain alterations and change in CGRP and PACAP levels in patients in comparison to healthy controls
    E.5.2.1Timepoint(s) of evaluation of this end point
    month 3 (day 75 +/-7)
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    - influence on structural and functional brain alterations
    - influence on levels of CGRP, PACAP, immune cell populations, cytokines
    - influence on quality of life, mood
    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 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 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 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
    End of trial will occur when the last patient completes his last visit (LPLV)
    ---------
    Comment to F4.1: We plan to include 64 patients who will receive Galcanezumab and 25 healthy controls who will not receive any treatment but MRI scans and laboratory exams, total number of subjects n=89.
    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 months0
    E.8.9.1In the Member State concerned 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: 89
    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 Yes
    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 state89
    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)
    End of trial treatment is reached at visit 5 (third and last administration of Galcanezumab).
    A follow up visit is performed 2 weeks after the last treatment administration (visit 6). A patient will be considered to have completed the study when the patient has completed Visit 6 in the protocol.
    There will be no further asessments or other kind of study treatment beyond the above named visits. After the end of the trial, patients will be treated according to standard of care (SOC).
    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 Decision2022-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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