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    Summary
    EudraCT Number:2011-002382-37
    Sponsor's Protocol Code Number:RIBO-01-2011
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-02-10
    Trial 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 number2011-002382-37
    A.3Full title of the trial
    Riboflavina como tratamiento profiláctico de la migraña.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Riboflavina como tratamiento profiláctico de la migraña.
    A.4.1Sponsor's protocol code numberRIBO-01-2011
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVirgilio Hernando Requejo
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVirgilio Hernando Requejo
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVirgilio Hernando Requejo
    B.5.2Functional name of contact pointHospital Universitario Severo Ochoa
    B.5.3 Address:
    B.5.3.1Street AddressAvda. de Orellana s/n. 28911 - Leganés
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28911
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491481 80 00
    B.5.5Fax numberNANANANA
    B.5.6E-mailvirgiliohernandorequejo@gmail.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 Riboflavina
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameRibloflavina
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNRiboflavina
    D.3.9.1CAS number 83-88-5
    D.3.9.3Other descriptive nameVitamina B2, Lactoflavin, Vitamina G
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Migraña
    E.1.1.1Medical condition in easily understood language
    Migraña
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    Porcentaje de pacientes con una reducción de 50% o mayor en el número de ataques migrañosos entre los meses 3 y 6, con respecto al primero (el mes de prueba)
    E.2.2Secondary objectives of the trial
    - Duración en horas del ataque migrañoso
    - Intensidad media del dolor por día:
    0= Sin dolor
    1= Dolor leve
    2= Dolor moderado
    3= Dolor severo
    4= Dolor muy severo
    5= Dolor insoportable
    - Porcentaje de pacientes que reducen >50% el número del días con migraña
    - Dosis mensual de triptanes
    - Dosis mensual de analgésicos convencionales
    - Día al mes de cefalea tensional
    - Días al mes de naúseas y vómitos
    - Efectos adversos percibidos durante el tratamiento
    - Cumplimiento terapéutico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adultos entre 18 y 65 años.
    - Criterios IHS para migraña con y sin aura.
    - Historia de migraña de al menos un año de evolución
    - Ataques en un número medio por mes entre 2 y 8 en los últimos 6 meses.
    - Toma de analgésicos < 15 días al mes.
    - No trastorno médico o psiquiátrico severo.
    - El paciente sabe diferenciar perfectamente entre sus migrañas y otros tipos de cefaleas.
    - Las mujeres se asegurarán de la anticoncepción durante el estudio.
    E.4Principal exclusion criteria
    - Embarazo, lactancia o intención de embarazo.
    - Otras cefaleas primarias, si el paciente no sabe distinguirlas de sus migrañas.
    - Cefalea a tensión frecuente (>15 días al mes)
    - Uso de analgésicos > 15 días al mes.
    - Tratamiento profiláctico antimigrañoso en los tres meses previos al inicio del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Porcentaje de pacientes con una reducción de 50% o mayor en el número de ataques migrañosos entre los meses 3 y 6, con respecto al primero (el mes de prueba)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 meses
    E.5.2Secondary end point(s)
    - Duración en horas del ataque migrañoso
    - Intensidad media del dolor por día:
    0= Sin dolor
    1= Dolor leve
    2= Dolor moderado
    3= Dolor severo
    4= Dolor muy severo
    5= Dolor insoportable
    - Porcentaje de pacientes que reducen >50% el número del días con migraña
    - Dosis mensual de triptanes
    - Dosis mensual de analgésicos convencionales
    - Día al mes de cefalea tensional
    - Días al mes de naúseas y vómitos
    - Efectos adversos percibidos durante el tratamiento
    - Cumplimiento terapéutico
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 meses
    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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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 fin de estudio será a los 6 meses del inicio del tratamiento
    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 days0
    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.1.2.1Number of subjects for this age range: 50
    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 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 2012-02-10. Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    El tratamiento o cuidados médicos queda a criterio del investigador principal.
    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 Decision2013-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-09
    P. End of Trial
    P.End of Trial StatusOngoing
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