Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2005-001335-30
    Sponsor's Protocol Code Number:NOS103325
    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:2007-02-05
    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 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.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberNOS103325
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 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 nameGW274150
    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
    Prohpylaxis of migraine headache
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10058734
    E.1.2Term Migraine prophylaxis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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 effect of repeat dose treatment of GW274150 upon the generation of NO by reference to tyrosine and its nitrosylated derivative NO-tyrosine 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 QoL, treatment satisfaction and productivity in subjects treated prophylactically with oral daily GW274150
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Females childbearing and non-childbearing potential , between 18 and 55 years of age. 2. Subjects, otherwise healthy, suffering from migraine with or without aura, according to 2004 IHS criteria 1.1 and 1.2.1 Appendix 2 . Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history including family , physical examination, laboratory studies, and other tests . 3. Subject has had migraine for at least one year, and the age of onset was prior to 50 years. 4. Subject has consistent migraine headache over time i.e., incidence and severity . 5. 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. 6. Subject is able to distinguish migraine headache attacks as discreet attacks from other headaches i.e. tension-type headaches . 7. 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. 8. Subject has the ability to read, comprehend and legibly and reliably record information in paper and electronic format as required by the protocol. 9. Subject gives written informed consent prior to entry into the study. 10. 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 listed below a. Female sterilization; or b. Male partner s who is are sterile prior to the female subject s entry into the study and is are the sole sexual partner s for that female subject; or c. Implants of levonorgestral within the lifetime of the implant; or d. Injectable progesterone; or e. Oral contraceptive combined or progestogen only started at least 2 months prior to the Screening Visit; or f. Documented placement of any Intrauterine Device IUD with published data showing that the highest expected failure rate is less than 1 per year; or g. Double barrier contraception e.g., a combination of physical and chemical methods, preferably a spermicide with either a condom or a diaphragm ; or h. Any other method of contraception with data documented in the product labelling as approved by regulatory agencies, or in the absence of approved labelling, in peer reviewed studies, showing that the highest expected failure rate for that method is less than 1 per year.
    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 follow-up 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.
    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. The primary safety endpoints include the incidence and severity of clinical adverse events, as well as changes from baseline to Weeks 2, 4, 6, 8 and 12 Visits for clinical laboratory parameters and vital signs, and ECG abnormalities at the Weeks 4, 8 and 12 Visits.
    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 Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    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 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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 2007-02-05. 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 320
    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 Decision2007-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-23
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Oct 31 13:27:52 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA