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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2006-000805-42
    Sponsor's Protocol Code Number:MeIn/06/Fro-pp/001
    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:2007-04-16
    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 number2006-000805-42
    A.3Full title of the trial
    Estudio cruzado, doble ciego para evaluar la preferencia de los pacientes entre frovatriptán y zolmitriptán para el tratamiento agudo de la migraña

    A double-blind, cross-over patient preference study of frovatriptan versus
    zolmitriptan for the acute treatment of migraine
    A.4.1Sponsor's protocol code numberMeIn/06/Fro-pp/001
    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 SponsorMenarini International Operations Luxembourg S.A., Avenue de la Gare, 1611 Luxembourg, Luxembourg
    B.1.3.4CountryGermany
    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 Migard
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxembourg S.A.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Capsule, hard
    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 INNFrovatriptan
    D.3.9.1CAS number 158747-02-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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 Yes
    D.3.11.13.1Other medicinal product type5-HT(1B/1D) receptor agonist
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 AscoTop
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule, hard
    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 INNZolmitriptan
    D.3.9.1CAS number 139264-17-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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 Yes
    D.3.11.13.1Other medicinal product type5-HT(1B/1D) receptor agonist
    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
    Migraña con o sin aura, según los criterios IHS

    Migraine with or without aura according to the IHS criteria
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10027599
    E.1.2Term Migraine
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este estudio es evaluar si los pacientes muestran por alguno de los medicamentos del estudio y la magnitud de dicha preferencia, tras haber probado ambos en 1 a 3 crisis de migraña durante un período máximo de 3 meses. Para ello se hará una evaluación independiente en los dos subgrupos.



    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de este estudio son evaluar, en la misma población objetivo, los motivos indicados por el paciente para explicar su preferencia, la proporción de episodios calificados como indoloros al cabo de 2 y 4 horas, los cambios en la intensidad de la migraña en 4 horas, la proporción de episodios que requieren una segunda dosis del fármaco o medicación de rescate, la proporción de episodios recurrentes y el tiempo transcurrido hasta la recurrencia.

    También se controlará la seguridad clínica (acontecimientos adversos, constantes vitales) antes del estudio y al final de cada período de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los sujetos sólo podrán participar en este estudio si cumplen todos los criterios siguientes:

    1. sujetos de ambos sexos ambulatorios (las mujeres no podrán estar embarazadas);
    2. edad ≥18 y £65 años de edad en la visita de aleatorización;
    3. historial reciente de migraña con o sin aura, según los criterios IHS;
    4. haber experimentado un promedio de al menos una crisis pero no más de seis crisis de migraña al mes en los 6 meses previos a la entrada en el estudio;
    5. con voluntad y capacidad para comprender y cumplimentar los cuestionarios del estudio previstos;
    6. con voluntad y capacidad para firmar el consentimiento informado antes de entrar en el estudio.
    E.4Principal exclusion criteria
    Los sujetos no podrán participar en este estudio si presentan alguna de las siguientes circunstancias:
    1. antecedentes indicativos de cardiopatía isquémica (CI; p. ej., infarto de miocardio, angina de pecho, vasoespasmo coronario, angina vasoespásmica [variante de Prinzmetal]) o de cualquier enfermedad aterosclerótica (p. ej., vasculopatía periférica) que suponga un aumento del riesgo de isquemia coronaria;
    2. síndrome de Wolff‑Parkinson‑White sintomático o arritmias cardíacas asociadas o otros trastornos de las vías de conducción accesorias cardíaca;
    3. antecedentes de ictus o de accidente isquémico transitorio (AIT);
    4. hipertensión no controlada;
    5. antecedentes de migraña basilar, hemipléjica u oftalmopléjica;
    6. insuficiencia hepática intensa (es decir, puntuación de Child‑Pugh C);
    7. alteración renal grave (es decir, CrCl <26 ml/min, nefropatía o insuficiencia renal;
    8. certeza o sospecha de intolerancia, hipersensibilidad o contraindicación de cualquiera de los componentes de los medicamentos del estudio, incluidas las sustancias inertes (p. ej., intolerancia a la galactosa, déficit de lactasa de Lapp, malabsorción de glucosa‑galactosa, fenilcetonuria);
    9. uso de cualquier medicamento experimental para tratar cualquiera de los tres últimos episodios de migraña;
    10. antecedentes de intolerancia o ineficacia a al menos dos triptanos para el tratamiento de las crisis de migraña:
    11. uso de ergotamina (o sus derivados) como preventivo en la actualidad;
    12. uso de IMAO en la actualidad o en las 2 últimas semanas;
    13. abuso de alcohol, analgésicos o psicofármacos;
    14. cualquier enfermedad simultánea intensa que, según el investigador del centro, pueda afectar a la interpretación de los resultados del ensayo clínico;
    15. embarazo o lactancia;
    16. participación en un ensayo clínico en el mes previo o participación en la actualidad en cualquier otro estudio de investigación clínica o ensayo clínico;
    17. incapacidad para firmar el consentimiento informado o negativa a hacerlo.
    18. más de seis días de dolor de cabeza por tensión.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal es la preferencia expresada por el paciente (en una escala analógica visual) por el primer o segundo de los tratamientos recibidos.

    Los criterios de valoración secundarios son:

    · el cuestionario sobre la preferencia del paciente;
    · la intensidad de la migraña, en concreto 2 y 4 horas después de la administración, evaluada como: suma del cambio de intensidad con respecto al valor previo a la administración, episodios con intensidad =”nula” a las 2 horas, episodios con intensidad =”nula” a las 4 horas;
    · el uso de una segunda dosis de medicación o de medicación de rescate para tratar el episodio de migraña (procesado como proporción de episodios y como proporción de pacientes que utilizan este procedimiento al menos en una ocasión);
    · recurrencia (otro episodio de migraña en las 48 horas siguientes a la administración, con un intervalo sin dolor claro entre medias), que será procesado como proporción de episodios recurrentes y como tiempo hasta la recurrencia;
    · proporción de episodios indoloros duraderos, definidos por ausencia de dolor dos horas después de la crisis de migraña, que no requieren medicación de rescate y que no recurren en un plazo de 48 horas;
    · grado de satisfacción del paciente al cabo de 48 horas;
    · proporción de pacientes que abandonaron prematuramente cualquiera de los períodos de observación debido a su extrema insatisfacción con el tratamiento asignado.
    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 Yes
    E.6.13.1Other scope of the trial description
    evaluation of patient´s preference for either study medication
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    active-drug controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    El final del ensayo se define como el "Informe Integrado del ensayo clínico (IIEC)" firmado por todas las partes.
    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 months0
    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 months0
    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 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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 120
    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)
    Finalizado el estudio, el investigador definirá y asignará el tratamiento que necesite el paciente para su cuidado tras completar el estudio, con arreglo a la mejor práctica médica.
    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 Decision2007-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-03
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    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.

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