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    Summary
    EudraCT Number:2011-002349-36
    Sponsor's Protocol Code Number:0462-107
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-06-30
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2011-002349-36
    A.3Full title of the trial
    An Open-Label Single-Dose Study to Evaluate the Pediatric Palatability of Maxalt Oral Disintegrating Tablets
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Taste Assessment of Maxalt Oral Disintegrating Tablets in Children
    A.3.2Name or abbreviated title of the trial where available
    No Abbreviated Title Available
    A.4.1Sponsor's protocol code number0462-107
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/27/2011
    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 supportMerck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck & Co., Inc.
    B.5.2Functional name of contact pointMatt S. Anderson, Ph.D.
    B.5.3 Address:
    B.5.3.1Street AddressP.O. Box 100, One Merck Drive
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number732594-3801
    B.5.5Fax number732594-5405
    B.5.6E-mailmatt_anderson@merck.com
    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-MLT
    D.2.1.1.2Name of the Marketing Authorisation holderMerck & Co., Inc.
    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 namerizatriptan benzoate
    D.3.2Product code MK-0462
    D.3.4Pharmaceutical form Dispersible 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.3.9.1CAS number 145202-66-0
    D.3.9.2Current sponsor code0462
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 145202-66-0
    D.3.9.2Current sponsor code0462
    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) 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
    Migraine
    E.1.1.1Medical condition in easily understood language
    Migraine headaches
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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
    To evaluate the palatability of Maxalt-MLT® ODT in pediatric migraineurs, ages 6 - 11 years.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of single doses of Maxalt-MLT® ODT in pediatric migraineurs, ages 6 - 11 years.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Consent
    a. The parent or guardian and subject agrees to the subject’s participation in the study as indicated by parental/guardian signature on the consent form and subject assent. Written assent will be sought from subjects of appropriate intellectual maturity. The subject is willing to comply with procedures, and is able to keep scheduled clinic visits.
    Demographics
    b. The subject is a male or female between the ages of 6 and 11 years of age (inclusive) on the day of screening.
    c. Female subjects of reproductive potential (or other female subjects at the discretion of the investigator) must demonstrate a serum β-hCG level consistent with the nongravid state at the prestudy (screening) visit and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the prestudy visit throughout the study and until 2 weeks after the dose of study. Acceptable methods of birth control are two (2) of the following: intrauterine device (IUD-with or without local hormone release), diaphragm, spermicides, cervical cap, contraceptive sponge, and /or condoms. Abstinence is an alternative life style and subjects practicing abstinence may be included in the study.
    d. The subject weighs at least 20 kg.
    Medical history, physical examinations, laboratory safety tests and ECG measurements
    e. Subject has a history of migraine (as defined by the Headache Classification Subcommittee of the International Headache Society [1]), for at least 6 months, but is judged to be otherwise in good health based on the basis of medical history, physical examination, vital sign measurements, and laboratory safety tests (see Appendix 6.1 and 6.2) performed at the prestudy (screening) visit and/or prior to administration of study drug.
    f. Subject has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening).
    g. Subject is not a nursing mother.
    Diet/Activity/Other
    h. Subject is a nonsmoker.
    i. Subject is willing to comply with the study restrictions (see Section 3.2. for a complete summary of study restrictions).
    E.4Principal exclusion criteria
    a. Subject or parent/legal guardian, is, in the opinion of the investigator, mentally incapacitated.
    b. Subject has no history of migraine headaches, or is experiencing a migraine headache on the day of study drug administration.
    c. Subject is <5th percentile or >95th percentile for age-appropriate Body Mass Index (see Appendix 6.5 and 6.6 for age-appropriate BMI charts for males and females).
    d. Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 2 years. Subjects who have had situational depression may be enrolled in the study at the discretion of the investigator.
    e. Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. Subjects with a history of uncomplicated kidney stones or childhood asthma may be enrolled in the study at the discretion of the investigator.
    f. Subject has a history of Kawasaki’s disease.
    g. Subject has a history of phenylketonuria.
    h. Subject has a history of hemiplegic or basilar migraine.
    i. Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study and in administering Maxalt-MLT® to the subject.
    j. Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 mL), or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit. The 4 week window will be derived from the date of the last study procedure (i.e. poststudy, AE follow-up, etc.) in the previous study to the prestudy/screening visit of the current study
    k. Subject consumes excessive amounts, defined as greater than 6 servings
    (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day..
    l. Subject has clinically significant abnormalities on prestudy clinical examination or laboratory measurements.
    m. Subject is a regular user (including "recreational use") of any illicit drugs, or has a history of drug or alcohol abuse.
    n. Subject has a history of significant drug allergy or any clinically significant adverse experience (e.g., drug-related rash, urticaria, anaphylaxis) related to the administration of sumatriptan, other triptans or any other marketed or investigational drug.
    o. Subject has a history of syncope.
    p. Subject has a history of taste or olfactory impairment.
    q. Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study.
    r. Subject is taking prescription or nonprescription medicines that cannot be discontinued 2 weeks prior to the study day (including herbal remedies such as St. John’s Wort), or is a current user of sumatriptan or other triptan or is a current user of monoamine oxidase (MAO) inhibitors or selective serotonin reuptake inhibitors (SSRIs).
    s. Subject has a history of stroke, chronic seizures, or major neurological disorder (other than history of migraines).
    t. Subject has a history of neoplastic disease.
    u. There is any concern by the investigator regarding the safe participation of the subject in the study or for any other reason, the investigator considers the subject inappropriate for participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Palatability Assessment
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 minutes postdose
    E.5.2Secondary end point(s)
    Safety and tolerability
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening, predose, poststudy
    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 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
    Palatability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Palatability
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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 (on 28Feb2011)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days42
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 12
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 12
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minor child ‘assent’ obtained along with parental consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 12
    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)
    Normal treatment for migraine headaches
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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