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    Summary
    EudraCT Number:2010-023992-24
    Sponsor's Protocol Code Number:MEMAP1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-11-18
    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 number2010-023992-24
    A.3Full title of the trial
    International randomised double-blind placebo-controlled study on
    the initial treatment of acute mania with methylphenidate
    Ensayo clínico internacional: Metilfenidato de liberación inmediata en el tratamiento sintomático de la Manía aguda.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    International randomised double-blind placebo-controlled study on
    the initial treatment of acute mania with methylphenidate
    Ensayo clínico internacional: Metilfenidato de liberación inmediata en el tratamiento sintomático de la Manía aguda.
    A.4.1Sponsor's protocol code numberMEMAP1
    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 SponsorUniversidad de Leipzig
    B.1.3.4CountryGermany
    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 supportMº Sanidad, Política Social e Igualdad
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportCAIBER
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaría Isabel Moreno Arza
    B.5.2Functional name of contact pointMaría Isabel Moreno Arza
    B.5.3 Address:
    B.5.3.1Street AddressC/ Diego de León, 62
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491520 25 40
    B.5.5Fax number+3491520 25 40
    B.5.6E-mailmariaisabel.moreno@salud.madrid.org
    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 Ritalin
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    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
    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 INNMETILFENIDATO HIDROCLORURO
    D.3.9.1CAS number 298-59-5
    D.3.9.3Other descriptive nameMETHYLPHENIDATE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Acute mania
    Manía aguda
    E.1.1.1Medical condition in easily understood language
    Acute mania
    Manía aguda
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLGT
    E.1.2Classification code 10026753
    E.1.2Term Manic and bipolar mood disorders and disturbances
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the hypothesis that methylphenidate immediate release given twice daily (BID) is significantly superior to placebo in the treatment of manic symptoms in patients with bipolar disorder after 2.5 days of treatment as assessed by the Young Mania Rating Scale (YMRS).
    Probar la hipótesis de que el metilfenidato de liberación inmediata dos veces al día (BID) es significativamente superior al placebo en el tratamiento de los síntomas maníacos en pacientes con trastorno bipolar después de 2.5 días de tratamiento según la evaluación de la Young Mania Rating Scale (YMRS).
    E.2.2Secondary objectives of the trial
    1. Methylphenidate immediate release given BID is significantly superior to placebo in the treatment of manic symptoms in patients with bipolar disorder after 2 hours of treatment as assessed by the YMRS
    2. 2.5 days of treatment with methylphenidate but not with placebo stabilise vigilance regulation as assessed by the ‘Vigilance Algorithm Leipzig’ (VIGALL)
    3. Instability of vigilance regulation as assessed by the VIGALL predicts response to methylphenidate immediate release
    4. Methylphenidate immediate release given BID is associated with significantly less movements over the study period than placebo as assessed by actigraphy
    5. Methylphenidate is significantly superior to placebo in improving sustained attention as assessed by the “Continuous Performance Test” (CPT)
    1. El metilfenidato de liberación inmediata administrado dos veces al día es significativamente superior al placebo en el tratamiento de los síntomas maníacos en pacientes con trastorno bipolar después de 2 horas de tratamiento según la evaluación de la YMRS
    2. Dos días y medio de tratamiento con metilfenidato, pero no con el placebo estabilizan la regulación de vigilancia según la evaluación de la "Vigilancia de Leipzig algoritmo (VIGALL)
    3. La inestabilidad de la regulación de la vigilancia según la evaluación de la VIGALL predice la respuesta al metilfenidato de liberación inmediata
    4. El metilfenidato de liberación inmediata administrado dos veces al día se asocia con los movimientos significativamente menores durante el período de estudio que el placebo según la evaluación de actigrafía
    5. El metilfenidato es significativamente superior al placebo en mejorar el rendimiento cognitivo, evaluado por el " Screen for Cognitive Impairment in Psychiatry (SCIP).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    After 20 patients treated in each group.
    Después de 20 pacientes tratados en cada grupo.
    E.3Principal inclusion criteria
    1. Written informed consent
    2. Diagnosis: manic episode according to ICD-10 classification:
    F30.0, F30.1, F31.0 and F31.1
    3. Male or female ±18 years of age
    4. YMRS total score between 20 and 45 points
    5. Patients must be able to swallow capsules (study drug).
    1. Consentimiento informado por escrito
    2. Diagnóstico: episodio maníaco según la CIE-10 Clasificación: F30.0 y F31.1
    3. Hombres o mujeres 18 años de edad
    4. YMRS puntuación total entre 20 y 45 puntos
    5. Los pacientes deben ser capaces de tragar las cápsulas (fármaco en estudio).
    E.4Principal exclusion criteria
    1.Any other current major ICD-10 disorder except for: (F40-48 Neurotic, stress-related and somatoform disorders, 50-F59 Behavioural syndromes associated with physiological disturbances and physical factors, F60-F69 Disorders of adult personality and behavior)
    2.Contraindications for treatment with methylphenidate.
    3.Serious non-psychiatric disease (e.g. infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator.
    4.Stable treatment with mood stabilisers including lithium, anticonvulsants (e.g. valproate, carbamazepine) or antipsychotics (e.g. risperidone, olanzapine) or benzodiazepines is NOT an exclusion criterion and will be continued; however, patients receiving more than 2 substances are NOT eligible for inclusion
    5.Other disorders of CNS including tics or dyskinesia.
    6.History of cardiovascular diseases, moderate to severe hypertension, glaucoma, hyperfunction of the thyroid.
    7.Patients with congenital or acquired long QT syndrome, or with a familiy history of QT prolongation or other significant inherited cardiac disorders (e.g. family history of hypertrophic cardiomyopathy).
    8.Electroconvulsive therapy within the last 2 years.
    9.Administration of MAO- inhibitors within the last 2 weeks.
    10.Known alcohol and drug addiction or abuse, except for patients with abstinence > 3 month. Patients with sporadic abuse of cannabis (products) will not be excluded from the study. That is even true with a positive THC screen in urine.
    11.Women with child bearing potential without effective contraception.
    12.Pregnant or breast-feeding.
    13.Concomitant participation in other clinical trials or participation during the 30 days prior to screening
    1. Trastorno importante de la CIE-10 a excepción de:
    (F40-48 Trastornos neuróticos, trastornos relacionados con el estrés y somatomorfos, 50-F59 Síndromes del comportamiento asociados con alteraciones fisiológicas y factores físicos, trastornos de F69-F60 de la personalidad y el comportamiento de adultos)
    2. Contraindicaciones para el tratamiento con metilfenidato.
    3. Enfermedad Grave no psiquiátricas (por ejemplo, infecciosas, autoinmunes o metabólico), que pueden interferir con los objetivos del estudio o con la seguridad o el cumplimiento de la materia, a juzgar por el investigador
    4. Tratamiento estable con estabilizadores del ánimo como el litio, los anticonvulsivos (por ejemplo, valproato, carbamazepina) o los antipsicóticos (por ejemplo, risperidona, olanzapina) o benzodiazepinas no es un criterio de exclusión y va a continuar, sin embargo, los pacientes que reciben más de dos sustancias no son elegibles para su inclusión
    5. Otros trastornos del sistema nervioso central como tics o discinesia,
    6. Historia de las enfermedades cardiovasculares, hipertensión moderada a severa, glaucoma hiperfunción de la tiroides
    7. Los pacientes con síndrome de QT largo congénito o adquirido, o con una historia familiar del prolongación del intervalo QT o de otros importantes enfermedades hereditarias (por ejemplo, la historia familiar de miocardiopatía hipertrófica).
    8. La terapia electroconvulsiva en los últimos dos años
    9. La administración de inhibidores de la MAO en las 2 últimas semanas
    10. Conocido el alcohol y la adicción a las drogas, excepto para los pacientes con la abstinencia> 3 meses
    11. Las mujeres con edad fértil sin un método anticonceptivo eficaz
    12. Embarazadas o en periodo de lactancia
    13. la participación simultánea en otros ensayos clínicos o la participación durante los 30 días anteriores a la selección
    E.5 End points
    E.5.1Primary end point(s)
    To test whether methylphenidate immediate release is significantly superior to placebo in the treatment of mania in patients with bipolar disorder after 2.5 days of treatment as assessed by the Young Mania Rating Scale (YMRS)
    Probar si el metilfenidato de liberación inmediata es significativamente superior al placebo en el tratamiento de la manía en pacientes con trastorno bipolar después de 2.5 días de tratamiento según la evaluación de la Young Mania Rating Scale (YMRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome will be analysed using confirmatory statistics.
    La variable principal se analizará usando análisis estadísticos confirmatorios.
    E.5.2Secondary end point(s)
    Efficacy
    2. Change from baseline to endpoint (after 2.5 days of treatment) on the CGI-BP and PANSS-EC
    3. Change from baseline to 2 h after first administration of study drug on the YMRS and PANSS-EC
    4. EEG-vigilance levels as assessed by the VIGALL
    5. Total amount of movements over the study period as assessed
    by actigraphy
    6. Change in sustained attention as assessed by the “Continuous Performance Test” (CPT)
    7. Change in cognitive performance as assessed by the “Screen for Cognitive Impairment in Psychiatry” (SCIP)
    Safety
    8. Adverse events (AE)
    9. Serious adverse events (SAE)
    10. Vital signs
    11. 12-lead ECG
    12. Clinical laboratory
    Eficacia:
    2. Cambio desde la situación basal al final del estudio (2,5 días) en las escalas CGI-BP y PANSS-EC.
    3. Cambio desde la situación basal a las 2 horas después de la primera administración del tratamiento en las escalas YMRS y PANSS-EC.
    4. Niveles de vigilancia en el EEG mediante VIGALL
    5. Cantidad total de movimientos corporales durante el periodo de estudio (2,5 días) mediante actigrafía.
    6. Cambio desde la situación basal al final del estudio (2,5 días) en la cognición evaluado con SCIP-S.
    Seguridad:
    7. Efectos adversos
    8. Efectos adversos graves
    9. Signos vitales
    10. ECG
    11. Tests de laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary variables will be analysed using exploratory and descriptive statistics, respectively.
    Todas las variables secundarias se estudiarán mediante análisis estadísticos exploratorios y descriptivos.
    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 No
    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 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.8.2.4Number of treatment arms in the trial2
    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 EEA6
    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
    LPLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 2011-11-18. 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 88
    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)
    Not applicable
    No aplica
    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 Decision2011-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-02-08
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