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    Summary
    EudraCT Number:2008-008283-26
    Sponsor's Protocol Code Number:0462-085
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-008283-26
    A.3Full title of the trial
    Ensayo multicéntrico cruzado, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la tolerabilidad de rizatriptán 10 mg CBD en el tratamiento de la migraña aguda en pacientes que siguen un tratamiento profiláctico de la migraña con topiramato.
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
    A.4.1Sponsor's protocol code number0462-085
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name MAXALT MAX 10 mg liofilizado oral
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP AND DOHME DE ESPAÑA, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameMaxalt
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNRIZATRIPTAN BENZOATO
    D.3.9.3Other descriptive nameRIZATRIPTAN BENZOATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Acute migraine
    Migraña Aguda
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10066635
    E.1.2Term Acute migraine
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of MK-0462 compared to placebo in the treatment of acute migraine in patients on topiramate for migraine prophylaxis, as measured by the proportion of treated attacks resulting in pain relief (PR) at 2 hours post-dose.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of rizatriptan compared to placebo in the treatment of acute migraine in patients on topiramate for migraine prophylaxis as measured by: (1) Sustained pain relief (SPR) from 2-24 hours post dose; (2) pain freedom (PF) at 2 hours post-dose; (3) Functional disability at 2 hours post-dose; (4) Patient satisfaction with treatment at 24 hours post-dose.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Hoja de Información Genética Doble Codigo (Versión 00: 29 de diciembre de 2008). Objetivo: Investigación genética futura.
    E.3Principal inclusion criteria
    Male or female at least 18 years of age.
    Patient has a history of migraine with or without aura > 1 year with ?2 and ?8 moderate or severe migraine attacks per month in the 3 months prior to screening.
    Patient is currently taking topiratmate for migraine prophylaxis, at a minimum daily dose of 50 mg and where the prescribed dose has been stable for at least 3 months.
    Female patients of reproductive potential must agree to use acceptable method of birth control.
    Patient understands study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
    Patient is able to complete the study questionnaire(s) and paper diaries.
    E.4Principal exclusion criteria
    Patient is pregnant, or breast-feeding, or is a female expecting to conceive within the projected duration of the study.
    Patient has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.
    Patient was > 50 years old at age of migraine onset.
    Aside from topiramate, patient is taking more than one other medication for migraine prophylaxis.
    Patient has a history or clinical evidence of cerebrovascular accident (CVA) or transient ischemic attack (TIA), ischemic heart disease, or other significant underlying cardiovascular disease or peripheral vascular disease.
    Patient has uncontrolled hypertension as determined by the investigator.
    Patient is taking or has been newly prescribed selective serotonin reuptake inhibitors (SSRI) or serotonin norepinephrine reuptake inhibitors (SNRI) where the prescribed daily dose has changed during the 3 months prior to screening.
    Patient is taking other migraine prophylactic medication where the prescribed daily dose has changed during the 3 months prior to screening.
    Patient has either demonstrated a hypersensitivity reaction, anaphylaxis or anaphylactoid reaction to or experienced a serious adverse event in response to rizatriptan.
    Patient has a history of hypersensitivity to more than two chemical classes of drugs, including prescriptions and over-the-counter medications.
    Patient has taken any of the following medications in the time frame specified: (1) Non-steroidal anti-inflammatory drugs (NSAIDS), COX-2 inhibitors, or other analgesics daily or nearly daily (typically >3 days out of 7 days average); (2) Monoamine oxidase inhibitors (MAOIs) or Propranolol within 1 month prior to screening and during the study. (Note: Aspirin ? 325 mg daily is allowed for cardioprotection.)
    Patient has a history of neoplastic disease ?5 years.
    Patient is legally or mentally incapacitated.
    Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening.
    Patient has a history (within the past 1 year) or current evidence of drug or alcohol abuse or is a 'recreational user' of illicit drugs or prescription medications.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: Pain relief (PR) at 2 hours post-dose, with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade1/0.
    Safety: Safety and tolerability will be assessed by review of all safety parameters, including adverse experiences and vital signs.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.6Cross over Yes
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last patient last visit
    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 months7
    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 months7
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 100
    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)
    Patient may resume routine treatment after last study visit.
    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 Decision2009-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-22
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