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    Summary
    EudraCT Number:2016-003846-97
    Sponsor's Protocol Code Number:PS-2016-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-10-19
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-003846-97
    A.3Full title of the trial
    Phenotypic and genotypic characterization of a tension-type headache
    population
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Biological characterization of a tension-type headache
    A.4.1Sponsor's protocol code numberPS-2016-01
    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 SponsorSection of Orofacial Pain and Jaw Function, Aarhus University
    B.1.3.4CountryDenmark
    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 supportSection of Orofacial Pain and Jaw Function, Aarhus University
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Dentistry and Oral Health, Aarhus University
    B.5.2Functional name of contact pointSection of Orofacial Pain
    B.5.3 Address:
    B.5.3.1Street AddressVennelyst Boulevard 9
    B.5.3.2Town/ cityAarhus
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.6E-mailfernando.exposto@dent.au.dk
    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.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMIRTAZAPINE
    D.3.9.3Other descriptive nameMIRTAZAPINE
    D.3.9.4EV Substance CodeSUB08996MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Tension-type headache
    Spændingshovedpine
    E.1.1.1Medical condition in easily understood language
    Tension headache
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10043269
    E.1.2Term Tension 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
    To characterize a population of tension-type headache patients by means of phenotyping and genotyping into different groups that would facilitate the selection of adequate treatment for each individual patient.
    E.2.2Secondary objectives of the trial
    1 - To assess if the response to treatment with mirtazapine of TTH
    patients can be predicted by conditioned pain modulation.
    2- To investigate the expression of NO, TNF-α, IL-1β, IL-6 and β2- and
    β3-adrenergic receptors in nerve fibers of muscles of Tension-type
    headache patients and controls.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    TTH participants:
    • Patients must fulfill the ICHD-3 criteria for either FETTH or CTTH
    • Taking or will be taking mirtazapine for prophylaxis of TTH
    • Between 18 and 65 years of age
    • Fertile women must use adequate contraception (oral contraceptive pills, intrauterine devices or birth control implant)
    • Participants must agree to participate in the study and sign informed consent
    Healthy participants
    • Between 18 and 65 years of age
    • Fertile women must use adequate contraception (oral contraceptive pills, intrauterine devices or birth control implant)
    • Participants must agree to participate in the study and sign informed consent
    E.4Principal exclusion criteria
    • No psychiatric or major medical conditions currently or in the past 12 months
    • No concurrent headache, pain symptoms or diagnoses other than that of TTH
    • Diagnosis of cancer presently or in the past 5 years
    • Abuse of drugs including alcohol
    • Diagnosis of Raynaud’s phenomenon
    • Having gone through a sympathectomy procedure
    • Diagnosis of cardiovascular disease
    • Diagnosis of lung insufficiency, including bronchial asthma
    • Diagnosis of diabetes mellitus
    • Pregnancy
    • Lactation
    • Students who are currently taught by any of the people related to the project
    • Participants who cannot follow the study protocol
    • Participants who do not agree to comply with the requirements for participation in all sessions concerning times, food intake and physical activity.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variables are number of headache days, severity of
    headache (on a 0-10 scale attack where where "0" is no pain/discomfort
    and "10" is the worst pain/discomfort) and amount of rescue medication
    taken.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline, 1 month after baseline and 2 months after baseline.
    E.5.2Secondary end point(s)
    The secondary variables are a modified total tenderness score (TTS) (0 to 100 scale with 0 being "no sensation whatsoever", 1 to 49 being
    "sensation of pressure but the stimulus is not painful", 50 being "barely painful" and 100 being "the most painful imaginable"), Quantitative sensory testing scores (QST), changes in PPTs during the conditioned pain modulation (CPM) paradigm, amount of expression of NO, TNF-α, IL-1β, IL-6 and β2- and β3-adrenergic receptors in nerve fibers of the assessed muscles and autonomic nervous system (ANS) variables such as heart rate variability.
    E.5.2.1Timepoint(s) of evaluation of this end point
    TTS, QST, CPM and ANS parameters will be assessed at baseline, 1
    month after baseline and 2 months after baseline.
    Assessment of expression of NO, TNF-α, IL-1β, IL-6 and β2- and β3-
    adrenergic receptors in nerve fibers of the assessed muscles will be done
    at baseline and 2 months after baseline.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3.1Comparator description
    Healthy Controls
    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.8.5The 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
    LVLS
    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 months2
    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: 108
    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 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 state108
    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 continue to receive standard of care, which is already
    what is being offered at this trial
    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 Decision2016-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-12-01
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