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    Summary
    EudraCT Number:2007-002667-28
    Sponsor's Protocol Code Number:MK0974-031
    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:2008-09-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-002667-28
    A.3Full title of the trial
    Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study
    to Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the Acute
    Treatment of Migraine With or Without Aura.
    titolo del piano clinico generale: Studio multicentrico in doppio cieco, controllato con Placebo a gruppi paralleli per valutare su attacchi multipli la sicurezza, la tollerabilita` e l`efficacia di MK-0974 per via orale con placebo nel trattamento dell`attacco acuto di emicrania con o senza aura.
    A.4.1Sponsor's protocol code numberMK0974-031
    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 SponsorMERCK & CO., INC.
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameNA
    D.3.2Product code MK0974
    D.3.4Pharmaceutical form 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 INNOther antimigraine preparations
    D.3.9.2Current sponsor codeMK0974
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number140
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patient has had a history of migraine with or without aura > 1 year with &#8805; 1 and &#8804; 8 moderate or severe migraine attacks per month in the 2 months prior to screening that typically last between 4 to 72 hours untreated
    Paziente con una storia di emicrania con o senza aura da piu' di 1 anno con attacchi di emicrania moderati o severi da 1 ad 8 al mese nei 2 mesi precedenti la visita di screening e della durata di 2 ore
    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 14.1
    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
    1) To evaluate the efficacy and safety of MK-0974 compared to placebo in the treatment
    of acute migraine.
    2) To evaluate the safety and the consistency of efficacy of MK-0974 across multiple
    migraine attacks.
    1) valutare la sicurezza e la tollerabilita' di MK-0974 rispetto a placebo nel trattamento
    dell'attacco acuto di emicrania.
    2) Valutare la sicurezza e la consistenza dell'efficacia di MK-0974 in attacchi multipli di
    emicrania.
    E.2.2Secondary objectives of the trial
    1) To evaluate the efficacy of MK-0974 (280 mg and 140 mg) compared to placebo in
    the treatment of acute migraine, as measured using sustained pain freedom from 2-24 hours and 2-48 hours post-dose and total migraine freedom at 2 hours and from 2-24 hours postdose (first attack only).
    1) Valutare l'efficacia di MK-0974 (280 mg e 140 mg) rispetto a placebo nel trattamento
    dell'attacco acuto di emicrania,valutando il parametro 'di liberta' prolungata dal
    dolore' da 2 a 24 ore e da 2 a 48 ore dopo la somministrazione e di liberta' assoluta dall'emicrania a 2 e da 2 a 24 ore dopo la prima somministrazione.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is &#8805;18 years of age at screening.
    2. Patient has had a history of migraine with or without aura > 1 year with &#8805; 1 and &#8804; 8
    moderate or severe migraine attacks per month in the 2 months prior to screening that
    typically last between 4 to 72 hours untreated (see Appendix 6.1 and ICHD II
    Attachment for IHS migraine definitions).
    3. Patient is either:
    a. of reproductive potential and agrees to maintain true abstinence* or use (or have
    their partner use) one of the listed highly effective methods of birth control within
    the projected duration of the study: hormonal contraceptives, intrauterine device
    0974, Protocol 031-00 Issue Date: 10-Mar-2008 15
    Product: MK-0974 7
    Protocol/Amendment No.: 031-00
    0974_031-00_ProtCore VERSION 6.0 APPROVED 10-Mar-2008
    Worldwide Restricted Confidential Limited Access
    (IUD), condoms, diaphragm, cervical cap, vasectomy. The use of barrier
    contraceptive (condom, diaphragm, or cervical cap) should always be
    supplemented with the use of a spermicide. Complete details regarding
    contraceptive requirements are specified in protocol Section 3.2.3.2.
    OR
    b. not of reproductive potential. The following definitions apply:
    A female patient who is not of reproductive potential is defined as:
    one who has either 1) reached natural menopause (defined as age 46 or older
    with a) 12 months spontaneous amenorrhea or b) 6 months of spontaneous
    amenorrhea with serum FSH levels in the postmenopausal range as
    determined by the central laboratory), 2) 6 weeks post surgical bilateral
    oophorectomy 3) hysterectomy, or 4) bilateral tubal ligation.
    A male patient who is not of reproductive potential is defined as:
    one who has undergone a successful vasectomy. A successful vasectomy is
    defined as: 1) microscopic documentation of azoospermia, or 2) a vasectomy
    more than 2 years ago with no resultant pregnancy despite sexual activity post
    vasectomy.
    * If abstinence is not a locally acceptable method of contraception, then another highly
    effective birth control method must be used.
    4. Patient understands the study procedures, alternative treatments available, and risks
    involved with the study, and voluntarily agrees to participate by giving written
    informed consent.
    5. Patient is able to complete the study questionnaire(s) and paper diary.
    1. Paziente con piu' di 18 anni al momento dello screening.
    2. Paziente con una storia di emicrania con o senza aura da piu' di 1 anno con attacchi di
    emicrania moderati o severi da 1 ad 8 al mese nei 2 mesi precedenti la visita di
    screening e della durata di 2 ore (vedere Appendice 6.1 per la definizione di emicrania
    secondo la IHS).
    3. Il paziente e':
    a) in eta' fertile pertanto si consiglia astinenza* dai rapporti o l'uso di due metodi
    accettabili di controllo delle nascite per tutta la durata dello studio (oppure avere un
    partner che utilizza tali metodi). I metodi accettabili di contraccezione sono: il
    dispositivo intrauterino (IUD), il diaframma con lo spermicida, la spugna
    contraccettiva, i preservativi, la vasectomia. Per completare le informazioni riguardanti
    i contraccettivi vedere la sezione 3.2.2.2. del protocollo
    oppure
    b) non in eta' fertile.Secondo le seguenti definizioni:
    o Una paziente donna non in eta' fertile viene definita tale se presenta 1)
    menopausa naturale (definita come 6 mesi di amenorrea spontanea con
    Merck Sharp & Dohme Italia Spa
    Principio attivo: MK0974
    Protocollo No.: 031-00
    Page 5 of 8
    livelli sierici di FSH postmenopausali determinati dal laboratorio
    centrale, o 12 mesi si amenorrea spontanea, 2) 6 settimane da
    un'ovariectomia chirurgica bilaterale, 3) isterectomia, o 4) legatura
    bilaterale delle tube.
    o paziente maschio non potenzialmente riproduttivo e' definito tale se
    presenta una vasectomia di successo. Una vasectomia di successo e'
    definita tale se e' presente: 1) documentazione microscopica di
    azoospermia, o 2) vasectomia eseguita da piu' di 2 anni e nessuna
    gravidanza postvasectomia nonostante attivita' sessuale.
    * Se l'astinenza non e' un metodo localmente accettabile di contraccezione, allora un
    altro metodo di controllo valido deve essere usato.
    4. Il paziente ad opinione dell'investigatore e' in buone condizioni di salute riferendosi
    alle valutazioni effettuate durante lo screening inclusi anamnesi, esame obiettivo ed
    esami di laboratorio effettuati entro 2 mesi dall'inizio dello studio
    5. Il paziente capisce le procedure dello studio, le terapie alternative disponibili, ed i
    rischi dello studio, e consente di partecipare dando volontariamente consenso informato
    scritto.
    6. Il paziente e' in grado di completare il/i questionario/i dello studio ed il diario.
    E.4Principal exclusion criteria
    1. Patient is pregnant (positive serum pregnancy test at pre-study) or breast-feeding, or
    is a female expecting to conceive within the projected duration of the study.
    2. Patient has difficulty distinguishing his/her migraine attacks from tension headaches.
    3. Patient has a history of predominantly mild migraine attacks or migraines that usually
    resolve spontaneously in less than 2 hours.
    4. Patient has basilar or hemiplegic migraine headache.
    0974, Protocol 031-00 Issue Date: 10-Mar-2008 16
    Product: MK-0974 8
    Protocol/Amendment No.: 031-00
    0974_031-00_ProtCore VERSION 6.0 APPROVED 10-Mar-2008
    Worldwide Restricted Confidential Limited Access
    5. Patient has more than 15 headache-days per month or has taken medication for acute
    headache on more than 10 days per month in any of the 3 months prior to screening.
    6. Patient is taking migraine prophylactic medication where the prescribed daily dose
    has changed during the 3 months prior to screening.
    7. Patient was > 50 years old at age of migraine onset.
    8. Patient has clinical, laboratory, or ECG evidence of uncontrolled hypertension
    (defined as SBP of &#8805;150 mm Hg and/or DBP of &#8805;95 mm Hg), uncontrolled diabetes,
    HIV disease, or significant pulmonary,
    1. paziente incinta (test ß-hCG sierico positivo al prestudy) o allatta al seno, o e' intenzionata a
    concepire una gravidanza entro la durata prevista dello studio.
    2. paziente con difficolta' a distinguere i propri attacchi di emicrania dalla cefalea tensiva o da
    intervallo.
    3. paziente con una storia di attacchi di emicrania prevalentemente lieve che si risolvono di
    solito spontaneamente in meno di 2 ore.
    4. paziente con emicrania basilare o emiplegica .
    5. paziente con piu' di 15 giorni di cefalea al mese o che ha intrapreso terapie per cefalea acuta
    per piu' di 10 giorni al mese nei 3 mesi precedenti lo screening.
    6. paziente che assume terapia profilattica per l'emicrania il cui dosaggio quotidiano e' stato
    modificato durante i 3 mesi precedenti lo screening.
    7. paziente con piu' di 50 anni al momento di insorgenza dell' emicrania.
    8. paziente con una storia clinica e di laboratorio od evidenze ECG di ipertensione non
    controllata (definita come PAS &gt; 150 mm Hg e/o PAD &gt; 95 mm Hg), diabete non controllato,
    malattia HIV, o significative malattie polmonari, renali, epatiche, endocrine,, o di altri sistemi,
    a discrezione del ricercatore.
    E.5 End points
    E.5.1Primary end point(s)
    2-hour pain
    relief, pain freedom, and associated symptoms (photophobia, phonophobia, and nausea)
    sollievo dal dolore a 2 ore (endpoint primario), assenza del dolore a 2 ore e anche per quanto riguarda i sintomi associati all'emicrania (fotofobia, fonofobia, and nausea)
    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 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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    .
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-09-22. Yes
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 744
    F.4.2.2In the whole clinical trial 1800
    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 Decision2008-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-27
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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