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    Summary
    EudraCT Number:2007-003392-39
    Sponsor's Protocol Code Number:M/31416/51
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-26
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-003392-39
    A.3Full title of the trial
    Standardized sTudy with Almotriptan in eaRly Treatment of migraine, START. An international, open-label, single arm, effectiveness and safety study of Almotriptan in primary care seeting.
    A.3.2Name or abbreviated title of the trial where available
    START
    A.4.1Sponsor's protocol code numberM/31416/51
    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 SponsorLaboratorios Almirall SA
    B.1.3.4CountrySpain
    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 almogran
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall SAS, France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 Information not present in EudraCT
    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
    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
    To describe the effectiveness of Almotriptan in treating acute migraine attacks when pain is mild and in the first hour of pain in everyday primary care clinical practice.
    E.2.2Secondary objectives of the trial
    A. Comparative (non-pharmacological)
    1. Influence of an educational intervention on the early intake of the treatment

    B. Descriptive:
    2. Influence of medication history or concomitant medication on treatment results
    3. Influence of migraine triggers on treatment results
    4. Influence of stress on treatment results
    5. Tolerability profile validation
    6. Patients’ satisfaction
    7. Reasons for delaying migraine treatment intake
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    . Subjects must have a history of a confirmed diagnosis of migraine that meets the IHS diagnosis criteria of migraine with or without aura for at least one year. (See attachment)2. Patients with a history of migraine headaches progressing from mild to at least moderate pain intensity if untreated on a scale of no pain (0), mild (1), moderate (2), or severe (3) within the past year.3. Patients must have a migraine headache frequency of 2 to 6 per month for the past 3 months. 4. Patients must be male or female aged 18 to 65 years.5. Patients must be able to differentiate a migraine headache from an interval (e.g., tension-type) headache.6. Patients may take a single medication effective for migraine prophylaxis, for any reason. If taking a medication effective for migraine prophylaxis, subjects must have been taking a maintenance dose for at least 1 month prior to the Screening Visit, and must remain on this stable dose for the duration of the trial. 7. Patients must be in generally good health as confirmed by medical and medication history, and baseline physical examination including vital signs.8. Female patients of childbearing potential must not suspect to be pregnant and have an effective method of birth control for at least 30 days prior to study entry and throughout the study (see note below). 9. Patients must be able to take oral medication, adhere to medication regimens, and perform study procedures. 10. Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the patient’s diary required by the protocol. 11. After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.12. Patients must either use Almotriptan for their migraine acute attacks treatment or prove through the ANAES scale in the basal visit that a change in their treatment approach is required.Note: Female patients of childbearing potential should be practicing an effective method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilisation) or hormonal contraceptives (i.e., oral contraceptives, contraceptive injections, contraceptive patch, contraceptive vaginal ring) for at least 30 days prior to study entry and throughout the study; or be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence.
    E.4Principal exclusion criteria
    Patients, who in the opinion of the investigator, should not be enrolled in the study because of the precautions, warnings or contraindications sections of the Almotriptan Summary of Product Characteristics (see protocol appendix).2. Patients who have had 15 or more headache days per month in the previous 6 months (chronic daily headache), or patients having a migraine headache frequency of more than 6 per month for the past 3 months. 3. Patients with onset of migraine after age 50. 4. Patients who routinely experience any other type of headache that would confound discrimination from a migraine.5. Patients who have exclusively migraine aura without headache.6. Patients who typically experience vomiting with their headaches.7. Patients with hemiplegic or basilar type migraines.8. Patients who typically have headaches that occur predominantly upon awakening in the morning.9. Patients who have previously discontinued Almotriptan therapy due to an adverse event or lack of efficacy. 10. Patients having started a new medication/s for any reason which is effective for the prophylaxis of migraine headache within 30 days of study entry (e.g. certain antiepileptic drugs, beta blockers, tricyclic antidepressants or calcium channel blockers)11. Patients taking any of the prohibited concomitant medications listed in Section 10.3.1 of the protocol. 12. Patients who have used any of the following medications within 7 days of study entry and during the trial: sustained release opioids and/or semi-synthetic or long acting opioids.13. Patients who require or overuse the following medications for any reason: NSAIDs, COX-2 selective inhibitors, aspirin*, paracetamol (acetaminophen), benzodiazepines (except anxiolytic/hypnotic uses) or antiemetics (more than 3 days per week); opioids, triptans (5-HT1B/1D receptor agonists) or ergotamine type medications (more than 2 days per week). *A stable, low dose of aspirin (≤ 325 mg per day) for cardiac prophylaxis is permitted (see Protocol, Section 10.C).14. Patients starting nonpharmacologic approaches for migraine treatment (e.g., acupuncture, biofeedback, chiropractic methods) within 14 days of Basal Visit. However, subjects using nonpharmacologic approaches for at least 14 days prior to Basal Visit and intend to maintain the same approaches for the duration of the study, will be permitted to enter the trial. Nonpharmacologic approaches cannot be started during the study.15. Patients known to have any significant, unstable medical disease (see Almotriptan SPC, attachment)16. Women who are pregnant or lactating. 17. Patients who have a current or recent history, or suspected history, of substance dependence or abuse within the past 6 months.18. Patients who have received an investigational drug or used an investigational device within 30 days of study entry.19. Patients unsuitable for the study for other reasons considered by the investigator as being relevant.
    E.5 End points
    E.5.1Primary end point(s)
    Main effectiveness endpoint:
    -2 h Pain Free
    Secondary effectiveness endpoints
    -Sustained Pain Free
    -SNAE (Sustained pain free and No Adverse Events)
    -24 h relapse
    -Second tablet / rescue medication use
    -Associated symptoms presence evolution: Nausea, Vomiting, Photophobia, Phonophobia. Basal - 2h - 24h
    -Migraine attack duration
    -Time loss (functional disability)
    Other secondary endpoints:
    -Patients’ satisfaction: Basal – At each attack
    -Consistency of response to treatment between attacks (2 h PF in 2/3 attacks)
    -Reported AEs
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 Yes
    E.8.2.3.1Comparator description
    Instructions versus without instructions
    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 concerned28
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 months9
    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) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state280
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 800
    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 Decision2007-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-23
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