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    Summary
    EudraCT Number:2011-004825-29
    Sponsor's Protocol Code Number:IIS-2011-01
    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:2011-11-22
    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 number2011-004825-29
    A.3Full title of the trial
    TREATMENT WITH ROTIGOTINE OF RLS PATIENTS WITH AN INSUFFICIENT RESPONSE TO DOPAMINE AGONIST WITH INTERMEDIATE HALF-LIFE.
    EVALUACIÓN DEL SÍNDROME DE PIERNAS INQUIETAS MEDIENTE EL TEST DE INMOVILIZACIÓN MÚLTIPLE (mSIT) EN PACIENTES BAJO TRATAMIENTO CON ROTIGOTINA Y CON ANTECEDENTES DE RESPUESTA INSUFICIENTE A LOS AGONISTAS DOPAMINÉRGICOS DE VIDA INTERMEDIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TREATMENT WITH ROTIGOTINE OF RLS PATIENTS WITH AN INSUFFICIENT RESPONSE TO DOPAMINE AGONIST WITH INTERMEDIATE HALF-LIFE.
    EVALUACIÓN DEL SÍNDROME DE PIERNAS INQUIETAS MEDIENTE EL TEST DE INMOVILIZACIÓN MÚLTIPLE (mSIT) EN PACIENTES BAJO TRATAMIENTO CON ROTIGOTINA Y CON ANTECEDENTES DE RESPUESTA INSUFICIENTE A LOS AGONISTAS DOPAMINÉRGICOS DE VIDA INTERMEDIA
    A.4.1Sponsor's protocol code numberIIS-2011-01
    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 SponsorInstituto de Investigaciones del Sueño
    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 supportInstituto de Investigaciones del Sueño
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Investigaciones del Sueño
    B.5.2Functional name of contact pointDr. Diego García-Borreguero
    B.5.3 Address:
    B.5.3.1Street AddressAlberto Alcocer, 19
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28036
    B.5.3.4CountrySpain
    B.5.4Telephone number34913454129
    B.5.5Fax number34913509593
    B.5.6E-maildgb@iis.es
    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 Neupro 2mg/24h transdermal patch
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Manufacturing Ireland Ltd.
    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.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROTIGOTINE
    D.3.9.1CAS number 99755-59-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 2
    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 Neupro 3mg/24h transdermal patch
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Manufacturing Ireland Ltd.
    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.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROTIGOTINE
    D.3.9.1CAS number 99755-59-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    Restless Legs Syndrom
    Síndrome de Piernas Inquietas
    E.1.1.1Medical condition in easily understood language
    Restless Legs Syndrom
    Síndrome de Piernas Inquietas
    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
    To investigate by m-SIT whether insufficient response to treatment with shorter-acting dopamine agonists is related to the presence of residual symptoms during the day in non-augmented RLS patients.
    Investigar mediante el m-SIT en qué medida una respuesta insuficiente al tratamiento con agonistas dopaminérgicos de semivida intermedia puede estar relacionada con la presencia de síntomas residuales diurnos en pacientes con SPI que no sufren de síntomas de aumento.
    E.2.2Secondary objectives of the trial
    To investigate by m-SIT whether treatment of RLS with rotigotine also improves SPI symptoms in patients with an insufficient response to shorter-acting dopamine agonists.
    Investigar mediante el m-SIT en qué medida rotigotina mejora
    adicionalmente los síntomas de SPI en este tipo de pacientes, es decir en pacientes con respuesta insuficiente a los agonistas dopaminérgicos de vida media intermedia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Idiopathic restless legs syndrome (RLS), according to diagnostic
    criteria established by the International RLS Study Group (Allen et al.,2003).
    2. If a previous PSG was performed, a PLMI>10.
    3. A history (if currently controlled on medication) or the presence of RLS symptoms on 4 or more days per week for at least 6 months.
    4. An IRLS score ?20 at baseline assessment (before dopaminergic treatment had been initiated). If not done at baseline, a retrospective evaluation upon the time before dopaminergic treatment was started shows a baseline value >20.
    5. Having undergone treatment with pramipexole with 2 diary doses (p.ex 0.25 mg at 3PM; 0.25 mg at 11PM)for the last four previous weeks to study initiation.
    6.An insufficient response to current dopaminergic treatment, defined by an IRLS score >15, 7. Not meeting during the clinical interview MPI diagnostic criteria for augmentation.
    8. Aged 18 - 80 years.
    9. Women of childbearing potential must have a negative pregnancy test at screen and must agree not to become pregnant.
    10. Prior to any study-specific procedures, a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
    1. Síndrome de piernas inquietas idiopático que cumplan los criterios diagnósticos establecidos por el grupo internacional de SPI (Allen, 2003).
    2. De haber realizado un estudio polisomnográfico previo, presentar un índice periódico de piernas > 10/hora.
    3. Presencia actual o por historia (en el caso de encontrarse controlado por medicación) de síntomas SPI cuatro o más días por semana a lo largo de los últimos 6 meses.
    4. Un índice en la escala de IRLS ? 20 en la evaluación basal (antes de haber iniciado el tratamiento dopaminérgico). Si dicha evaluación no se realizó en su momento, una evaluación retrospectiva (sobre el periodo anterior a comenzar el tratamiento dopaminérgico) que muestra una puntuación superior ? 20 puntos.
    5. Haber realizado un tratamiento con pramipexol (con dos dosis diarias, p.ej., 0,25 mg. a las 3PM y 0,25 mg. antes de dormir) durante las últimas 4 semanas antes de iniciar el estudio.
    6. Respuesta insuficiente al tratamiento con pramipexol, con una
    puntuación actual, bajo tratamiento, en la escala IRLS superior a 15.
    7. No presentar actualmente criterios diagnósticos de potenciación
    (Augmentation) (Garcia-Borreguero, 2007).
    8. Edad entre 18-80 años.
    9. Las mujeres premenopáusicas deberán dar negativo en la prueba de embarazo en suero o en orina en la visita de selección, y aceptar el empleo de métodos anticonceptivos adecuados al menos desde los 14 días previos a la primera dosis del fármaco de estudio hasta los 14 días siguientes a la última.
    10. Antes de cualquier procedimiento específico al estudio, debe constar el Documento Consentimiento Informado firmado y fechado personalmente (o por su representante legal).
    E.4Principal exclusion criteria
    1. Any secondary forms of RLS.
    2. History or current diagnosis of other clinically relevant diseases that may confound assessments or RLS symptoms.
    3. Serum ferritin <18 mcg/ml 4. Current use of drugs likely to influence sleep architecture or motor manifestations during sleep. These include neuroleptics, l-dopa, dopamine agonists, hypnotics, sedatives, antidepressants, anxiolytics, anticonvulsants, psychostimulant medications, steroids, barbiturates and opiates. If the patient is on any of these drugs, a washout period of
    >5 half-lives.
    5. Employed in shift work (for example, employment hours disruptive to the normal circadian sleep-wake cycle such as nighttime or variable rotating shifts) or irregular sleep-wake schedules.
    6. Patients who require prescription medication for concurrent
    conditions which could interfere with efficacy assessments.
    7- Medical disorder which could cause pain
    8- Significant medical or psychiatric disorder.
    9- Patients under treatment for concomitant diseases that may interfer with efficacy parameters.
    10_ Any acute or chronic disease that may interfer with efficacy
    parameters.
    11-Surgery within 180 days of baseline visit, which in the opinion of the investigator would negatively impact the patient's participation in the study.
    12- Any other clinically significant condition or laboratory assay
    abnormality, which would interfere with the patient's ability to
    participate in the study.
    13- Breastfeeding
    14- Any known hypersensibility or intolerance to the study drug or
    similars.
    15- Any significant renal disease that may interfer in completing the study or seric creatinine >1,5 the maximum of the normal range for the laboratory.
    16- Severe alcoholism or drug addiction in the last 12 months.
    1- Formas secundarias de SPI
    2- Historia o diagnóstico actual de otras enfermedades clínicamente
    relevantes que
    3- Puedan confundir la evaluación de síntomas de SPI.
    4- Ferritina sérica inferior a 18 mg/ml.
    5-Utilización actual de otro tipo de fármacos que puedan alterar la
    arquitectura del sueño o producir manifestaciones motoras durante el sueño. Si el paciente se encuentra con algún fármaco de este tipo deberá realizar un periodo de lavado superior a 5 semividas.
    6-Trabajo por turnos o trabajo con turnos sueño-vigilia irregulares.
    7- Trastornos médicos que produzcan dolor.
    8- Alteraciones médicas o psiquiátricas severas.
    9- Pacientes que requieran prescripción de medicación para
    enfermedades concomitantes que pueda interferir con los parámetros de eficacia.
    10-Cualquier enfermedad aguda o crónica médica o psiquiátrica severa que pueda resultar en alteración de los parámetros de laboratorio e incrementar el riesgo en la participación en este estudio.
    11-Cirugía a lo largo de últimos 180 días previos a la visita basal que en opinión del investigador pudiera impactar negativamente con la participación en el estudio.
    12- Cualquier otra condición clínica significativa o de laboratorio que pueda interferir con la capacidad del paciente para participar en el estudio.
    13- Lactancia.
    14- Pacientes que presenten una hipersensibilidad e intolerancia
    conocida a cualquier componente del fármaco al estudio o a fármacos similares.
    15- Enfermedad renal clínicamente significativa que pueda impedir que el paciente complete el estudio, o una elevación de la creatinina sérica superior a 1,5 veces el límite máximo del rango de laboratorio normal. Los análisis anormales que supongan la no inclusión de un paciente, pueden repetirse una vez, antes de la visita basal, con el fin de confirmar o no que el paciente sea incluible.
    16-Historia de alcoholismo crónico o de abuso de drogas en los últimos 12 meses.?
    E.5 End points
    E.5.1Primary end point(s)
    The principal end point is based on m-SIT difference between mean value SIT-DI (M-SIT disturbance index) In visits 3 and 4 and mean value in visits1 and 2 will be assessed.
    El criterio de valoración principal estará basado en el test de inmovilización múltiple. En concreto, se calculará la diferencia entre el valor medio del m-
    SIT-DI (M-SIT disturbance index) en las visitas 3 y 4 y las visitas 1 y 2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4 after Rotigotine treatment, after treatment switch.
    Semana 4 de tratamiento con Rotigotina después del cambio de tratamiento
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    LVLS
    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 months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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.1.1.1In 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    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)
    This information is included in the protocol
    Esta información está incluida en el protocolo
    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 Decision2011-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
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