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    Summary
    EudraCT Number:2005-001335-30
    Sponsor's Protocol Code Number:N0S103325
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-10-04
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-001335-30
    A.3Full title of the trial
    A Multicentre, Two-Part, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Tolerability and Pharmacokinetics of the iNOS Inhibitor GW274150 Administered up to 120mg Daily for 12 Weeks in the Prophylactic Treatment of Migraine.
    A.4.1Sponsor's protocol code numberN0S103325
    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 SponsorGlaxoSmithKline R&D
    B.1.3.4CountryUnited Kingdom
    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 Information not present in EudraCT
    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.3.2Product code GW274150
    D.3.4Pharmaceutical form Film-coated 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.3.9.2Current sponsor codeGW274150F
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.IMP: 2
    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 Information not present in EudraCT
    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.3.2Product code GW274150
    D.3.4Pharmaceutical form Film-coated 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.3.9.2Current sponsor codeGW274150F
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    Prophylaxis of migraine headache
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to estimate the dose-response and dose-safety relationships for GW274150 in the prophylaxis of migraine.
    E.2.2Secondary objectives of the trial
    •To explore efficacy of each dose of GW274150 compared with placebo using various clinical endpoints in the prophylaxis of migraine headaches

    •To investigate the safety and tolerability of GW274150 in the prophylaxis of migraine headaches

    •To evaluate the pharmacokinetics of GW274150

    •To evaluate the relationship between systemic GW274150 exposure and the prophylaxis of migraine headaches

    •To evaluate the relationship between systemic GW274150 exposure and safety and tolerability endpoints in migraineurs

    •To explore potential relationships between genetic variants and GW274150 efficacy endpoints

    •To determine the change in migraine-related quality of life, treatment satisfaction and productivity in subjects treated prophylactically with oral daily GW274150 compared to subjects treated prophylactically with placebo
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subjects, otherwise healthy, suffering from migraine with or without aura, according to 2004 IHS criteria 1.1 and 1.2.1 (see Appendix 2 of protocol).

    Subject has had migraine for at least one year, and the age of onset was prior to 50 years.

    Subject has consistent migraine headache over time (i.e., incidence and severity).

    Subject had at least 3 migraine headache attacks but less than 15 headache days(migraine or non-migraine) per month in each of the three months prior to the Screening Visit and maintains this requirement during the baseline period.

    Subject is able to distinguish migraine headache attacks as discreet attacks from other headaches (i.e., tension-type headaches).

    No clinically significant abnormality identified on the medical or laboratory evaluation, including 12–lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.

    A female is eligible to enter and participate in this study if she is of:
    a) non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal (>1 year since last menstrual cycle), had a documented tubal ligation or is surgically sterilized); or, b) child-bearing potential, has a negative pregnancy test (urine) at screen, and agrees to one of the following:

    1. Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the Treatment Period and for a minimum of one week after completion or premature discontinuation from investigational product; or

    2. Consistent and correct use of an acceptable method of birth control as outlined in the protocol.
    E.4Principal exclusion criteria
    1. As a result of the medical interview, physical examination or screening
    investigations, that the Investigator or appropriately qualified designee considers the
    subject unfit for the study.
    2. Subject has headache for 15 days per month or greater in any of the three months (90
    days) preceding the Screening Visit.
    3. Subject has history of alcohol, substance or drug abuse within the last year.
    4. Subject has taken a migraine prophylactic medication within 1 month of the
    Screening Visit.
    5. Subject uses an opiate as first line acute treatment for migraine attacks.
    6. Subject has history of ergotamine, triptan, opioid, or combination medication intake
    on ≥10 days per month on a regular basis for ≥3 months.
    7. Subject has history of simple analgesic intake on ≥15 days per month for ≥3months.
    8. Subject has failed two or more adequate treatments of migraine prophylaxis -where
    failure is defined as a lack of efficacy with a treatment duration of at least 8 weeks or
    withdrawal of treatment due to treatment intolerance.
    9. Subject has uncontrolled hypertension at the Screening Visit, defined as persistent
    (after 3 readings) systolic blood pressure >140mmHg or diastolic blood pressure
    >90mmHg; measured after 10 minutes of rest.
    10. Subject is taking cyclosporine and/or aminoglycosides.
    11. Evidence of renal impairment - calculated creatinine clearance < 60ml/min
    (Cockroft-Gault formula, Appendix 4) or clinically relevant finding (more than 1+
    protein or blood) on urinalysis (including microscopy).
    12. Subject has a history of drug or other allergy which, in the opinion of the
    Investigator, makes the subject unsuitable for participation in the study.
    13. Subject is concurrently participating in another clinical study or investigational drug
    trial or has participated within the previous 3 months or is planning to participate in
    another drug or device study at any time during this study (screening through followup)
    or has had previous exposure to GW274150 in Part 1 of the study.
    14. Subject is felt to be at risk of non-compliance (for taking study medication or for
    completing the electronic diary (e-diary)), in the Investigator’s opinion.
    15. Pregnant or nursing women.
    16. History of, or risk factors for, HIV, Hepatitis B and Hepatitis C.
    17. Past or present disease, which as judged by the investigator, may affect the outcome
    of this study. These diseases include, but are not limited to history of liver or renal
    disease in the 6 months prior to screening.
    18. Clinically significant abnormalities in safety laboratory analysis at the Screening
    Visit. Particularly any liver function test (including ALT, AST and ALP) or
    pancreatic function test (pancreatic amylase or lipase) >1.5 x upper limit normal
    (ULN) at the Screening Visit.
    19. The subject is not covered by social security (requirement for subjects recruited in
    France)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the occurrence of a migraine headache day on each day during the 4-week baseline period and the 12-week treatment period, where a migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. This analysis will be conducted after Part 1 and Part 2
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) 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 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 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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) 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 Information not present in EudraCT
    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 2005-10-04. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 308
    F.4.2.2In the whole clinical trial 375
    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 not be offered any further treatment with study medication after the Week 12 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 Decision2005-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
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