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    Summary
    EudraCT Number:2011-005839-91
    Sponsor's Protocol Code Number:IMPULPARK
    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:2012-01-11
    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 number2011-005839-91
    A.3Full title of the trial
    Gabapentin int he disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo.
    Gabapentina en el trastorno de control de impulsos de la enfermedad de Parkinson: estudio multicéntrico, doble ciego, aleatorizado, controlado con placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Gabapentin in the disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo.
    Gabapentina en el trastorno de control de impulsos de la enfermedad de Parkinson: estudio multicéntrico, doble ciego, aleatorizado, controlado con placebo
    A.3.2Name or abbreviated title of the trial where available
    IMULPARK
    IMPULPARK
    A.4.1Sponsor's protocol code numberIMPULPARK
    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 SponsorASOCIACIÓN INSTITUTO BIODONOSTIA
    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 supportMINISTERIO DE SANIDAD Y POLITICA SOCIAL
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASOCIACION INSTITUTO BIODONOSTIA
    B.5.2Functional name of contact pointUNIDAD DE ENSAYOS CLINICOS
    B.5.3 Address:
    B.5.3.1Street AddressPº DR. BEGUIRISTIAN S/N
    B.5.3.2Town/ cityDONOSTIA-SAN SEBASTIAN
    B.5.3.3Post code20014
    B.5.3.4CountrySpain
    B.5.4Telephone number0034943006012
    B.5.5Fax number0034943006250
    B.5.6E-mailanabelen.asensiohuerga@osakidetza.net
    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 GABAPENTINA KERN PHARMA
    D.2.1.1.2Name of the Marketing Authorisation holderKERN PHARMA
    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 Capsule, hard
    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 INNGABAPENTINA
    D.3.9.1CAS number 60142-96-3
    D.3.9.3Other descriptive nameGABAPENTIN
    D.3.9.4EV Substance CodeSUB07857MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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, hard
    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
    PARKINSON´S DISEASE
    ENFERMEDAD DE PARKINSON
    E.1.1.1Medical condition in easily understood language
    PARKINSON´S DISEASE
    ENFERMEDAD DE PARKINSON
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system 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 study the efficay of gabapentin versus placebo in the disorder of impulse control in the Parkinson´s disease, using for its evaluation the Questionnaire for Impulsive-Compulsive Disorder in Parkinson´s Disease.
    Estudiar la eficacia de la gabapentina versus placebo en el Trastorno de control de impulso (TCI) de la enfermedad de Parkinson (EP), mediante la evaluación de su gravedad usando el cuestionario Score in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS).
    E.2.2Secondary objectives of the trial
    1.To verify if the treatment with gabapentin leads to changes in the Parkinson´s motor state.
    2.To evaluate if gabapentin modifies the anxiety and depression associated to the disorder of impulse control in the Parkinson´s disease.
    3.To analyze if gabapentin has any other effect on the motor aspects related to the Parkinson´s Disease.
    4.To study if the treatment with gabapentin associates to apathy.
    5.To determine the effect of gabapentin versus placebo in the patient´s quality of life.
    6.To verify the security and tolerability of gabapentin, evaluated by the presence of secondary effects.

    1. Comprobar si el tratamiento con gabapentina induce cambios en el estado motor parkinsoniano.
    2. Estudiar si la gabapentina modifica la ansiedad y depresión, que frecuentemente se asocian con el TCI en la EP.
    3. Analizar si la administración de gabapentina tiene efecto sobre otros aspectos no motores relacionados con la EP.
    4. Estudiar si el tratamiento con gabapentina se asocia con apatía (como rasgo de conducta opuesto a la impulsividad)
    5. Determinar el efecto de gabapentina versus placebo en la calidad de vida de los pacientes con TCI.
    6. Comprobar el grado de seguridad y tolerabilidad de la gabapentina, evaluada por la presencia de efectos secundarios, en esta población de pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subjects with Parkinson´s disease treated with dopaminergic drugs.
    2.Subjects that present disorder of impulse control according to the validated diagnostic criteria (parkinson´s Disease Impulsive-compulsive Disorders diagnostic interview; Weintraub et al, Mov Disror 2009;30:1461-7) who after the gradual reduction of the dopaminergic treatment continue presenting disrorder of the impulse control.
    3.Older than 18 years old.
    4.Signed informed content.
    5.Women of childbearing age should get a negative pregnancy test in serum or urine at the screening visit, and accept the use of adequate contraception for at least 14 days before the first dose of study drug to the 14 days after the last. Postmenopause is defined as the absence of menstruation during the year prior to study entry.
    6.In men with couples of childbearing age, accept the use of contraceptive methods.

    1.Presentar EP tratada con fármacos dopaminérgicos
    2.Presentar TCI según los criterios diagnósticos validados (Parkinson's Disease Impulsive-Compulsive Disorders diagnostic interview; Weintraub et al, Mov Disord 2009; 30:1461-7) que tras la reducción gradual del tratamiento dopaminérgico (ver diseño) continúen presentando TCI. Aquellos pacientes en los que persista el TCI (si bien su intensidad puede haberse reducido como consecuencia de la reducción dopaminérgica) cuando alcancen la reducción significativa en la escala UPDRS motora, o presenten un agravamiento en las complicaciones motoras (fluctuaciones y/o disquinesias) según la UPDRS-IV, serán los sujetos considerados para la aleatorización al tratamiento con gabapentina o placebo.
    3.Ser mayor de 18 años.
    4.Firmar el consentimiento informado.
    5.Las mujeres en edad fértil deberán obtener un resultado negativo en la prueba de embarazo en suero ó en orina en la visita de selección, y aceptar el empleo de métodos anticonceptivos adecuados al menos 14 días previos a la primera dosis del fármaco del estudio hasta los 14 días siguientes a la última. Se define la postmenopausia como la ausencia de menstruación durante el año anterior a la entrada en el estudio.
    6.En varones que tengan pareja en edad fértil, aceptar el empleo de métodos anticonceptivos.
    E.4Principal exclusion criteria
    1.Subjects with psycosis (hallucination, delirium, etc).
    2.Subjects with dementia.
    3.Subjects treated through deep cerebral stimulation for the Parkinson´s Disease or any other cerebral intervention.
    4.Subjects with renal failure.
    5.Patients treated with antiepileptic drugs.
    6.Patients treated with atypical neuroleptic drugs.
    7.Subjects with physical or psychical inability to participate in the study.
    8.Pregnant women or under lactation.
    1.Pacientes con psicosis (alucinaciones, delirio, etc)
    2.Pacientes con demencia
    3.Pacientes tratados mediante estimulación cerebral profunda para la EP o con otras intervenciones cerebrales
    4.Pacientes con fallo renal
    5.Pacientes en tratamiento con antiepilépticos
    6.Pacientes en tratamiento con neurolépticos atípicos.
    7.Pacientes con incapacidad física o psíquica para participar en el ensayo
    8.Pacientes embarazadas o en fase de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Score in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson´s Disease- Rating Scale.
    Puntuación en la escala que evalúa la gravedad del TCI en la EP (Score in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    EVERY VISIT
    EN CADA VISITA
    E.5.2Secondary end point(s)
    1. Score in the Unified Parkinson´s Disease Rating Scale, motor section that evaluates the degree of parkinsonism (UPDRS-III).
    2. Score in the Unified Parkinson´s Disease Rating Scale, motor complications section, which evaluates motor fluctuations and dischinesia (UPDRS-IV).
    3. Score in the PDQ39 (quality of live).
    4. Score in the Parkinson´s Disease Rating Scale daily life activities section (UPDRS-II).
    5. Score in the Starkstein apathy scale and impulsivity in the Barrat scale.
    6. Score in the Hamilton ansiety and depression scale (HADS).
    7. Presence of motor symptom detected in the scale of Parkinson´s Disease Nonmotor Symptoms Questionnaire (NMSQ).
    8. Score in the sleepiness scale of Epworth.
    9. Incidence of secondary effects in patients treated with gabapentin and placebo.
    1. Puntuación en la Unified Parkinson’ disease Rating Scale sección motora (UPDRS-III) que evalúa el grado de parkinsonismo (incapacidad motora)
    2. Puntuación en la Unified Parkinson’ disease Rating Scale sección de complicaciones motoras (UPDRS-IV) que evalúa fluctuaciones motoras y disquinesias
    3. Puntación en la escala PDQ39 que evalúa calidad de vida en la EP
    4. Puntuación en la Unified Parkinson’ disease Rating Scale sección actividades de la vida diaria (UPDRS-II)
    5. Puntuación en las escalas de apatía de Starkstein y de impulsividad de Barrat
    6. Puntuación en la escala de ansiedad y depresión de Hamilton (HADS)
    7. Presencia de síntomas no motores detectados con la escala para la EP Nonmotor Symptoms Questionnaire (NMSQ)
    8. Puntuación en la escala de somnolencia de Epworth
    9. Incidencia de efectos secundarios en pacientes tratados con gabapentina y placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    EVERY VISIT
    EN CADA VISITA
    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 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 concerned2
    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
    When completed the statistical analysis of all results.
    Cuando finalicen los análisis estadísticos de todos los resultados.
    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
    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) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state100
    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)
    Patients at the end of their participation in the trial, will continue their usual treatment.
    Los pacientes, al finalizar su participación en el ensayo, continuarán con su tratamiento habitual.
    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 Decision2012-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
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