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    Summary
    EudraCT Number:2009-017248-14
    Sponsor's Protocol Code Number:P09-08/BF2.649-HAROSAI
    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:2010-12-09
    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 number2009-017248-14
    A.3Full title of the trial
    BF2.649 en pacientes con síndrome de apnea obstructiva del sueño (SAOS) tratados con presión positiva continua nasal de las vías respiratorias (nCPAP) que todavía refieren somnolencia diurna excesiva (SDE).

    BF2.649 in patients with Obstructive Sleep Apnoea syndrome (OSA), and treated by nasal Continuous Positive Airway Pressure (nCPAP), but still complaining of Excessive Daytime Sleepiness (EDS).
    A.3.2Name or abbreviated title of the trial where available
    HAROSA I
    A.4.1Sponsor's protocol code numberP09-08/BF2.649-HAROSAI
    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 SponsorBIOPROJET
    B.1.3.4CountryFrance
    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 No
    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 namePitolisant
    D.3.2Product code BF2.649
    D.3.4Pharmaceutical form Capsule*
    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 INNPitolisant
    D.3.9.2Current sponsor codeBF2.649
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 No
    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 namePitolisant
    D.3.2Product code BF2.649
    D.3.4Pharmaceutical form Capsule*
    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 INNPitolisant
    D.3.9.2Current sponsor codeBF2.649
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.IMP: 3
    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 No
    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 namePitolisant
    D.3.2Product code BF2.649
    D.3.4Pharmaceutical form Capsule*
    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 INNPitolisant
    D.3.9.2Current sponsor codeBF2.649
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    D.IMP: 4
    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 No
    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 namePitolisant
    D.3.2Product code BF2.649
    D.3.4Pharmaceutical form Tablet
    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 INNPitolisant
    D.3.9.2Current sponsor codeBF2.649
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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
    Pacientes con síndrome de apnea obstructiva del sueño (SAOS) tratados con presión positiva continua nasal de las vías respiratorias (nCPAP) y que todavía refieren somnolencia diurna excesiva (SDE).

    Patients with Obstructive Sleep Apnoea syndrome (OSA), and treated by nasal Continuous Positive Airway Pressure (nCPAP), but still complaining of Excessive Daytime Sleepiness (EDS).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10015595
    E.1.2Term Somnolencia diurna excesiva
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El primer objetivo de este estudio es demostrar la eficacia y la seguridad de BF2.649 en dosis de 5, 10 ó 20 mg una vez al día frente a placebo durante 12 semanas en el período doble ciego para tratar la somnolencia diurna excesiva en pacientes con apnea obstructiva del sueño moderada o grave que presentan somnolencia residual a pesar del uso de la presión positiva continua nasal de las vías respiratorias (nCPAP).
    E.2.2Secondary objectives of the trial
    El segundo objetivo es evaluar la tolerancia a largo plazo, así como el mantenimiento de la eficacia de BF2.649 administrado en dosis de 5, 10 ó 20 mg una vez al día durante 40 semanas.

    El diagnóstico queda respaldado por las exploraciones de polisomnografía en el tratamiento con nCPAP (excepto los pacientes que se hayan sometido a polisomnografía con nCPAP durante los últimos doce meses).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pacientes de ambos sexos, con al menos 18 años de edad y en régimen ambulatorio.
    Pacientes que se hayan sometido a tratamiento con nCPAP durante un período mínimo de 3 meses y sigan refiriendo somnolencia diurna excesiva a pesar de los esfuerzos para realizar un tratamiento con nCPAP eficaz.
    Polisomnografía realizada durante el tratamiento con nCAP, entre las visitas V1 y V2 o durante los últimos 12 meses en pacientes sometidos a tratamiento con nCAP con:
    Índice de hipoapnea-apnea (AHI) 10 durante el tratamiento con nCAP
    Trastornos de movimiento periódico de extremidades (PLM). Definidos como índice de despertares inducidos por el PLM (PLMAI) 10 por hora.
    nCPAP 4 horas/día (cumplimiento comprobado en el contador de tiempo de la máquina de CPAP).
    Examen breve del estado mental (MMSE) 28.
    Inventario de depresión de Beck (BDI) de 13 ítems < 16 e ítem G (ideas de suicidio) de BDI13 = 0.
    Índice de masa corporal (IMC) 40 kg/m2.
    Escala de somnolencia de Epworth (ESS) 12.
    Mujeres en edad fértil que utilicen un método anticonceptivo médicamente aceptado (es decir, anticonceptivos orales de dosis media normal), que estén dispuestas a continuar con este método a lo largo del estudio y durante el mes posterior a la suspensión del tratamiento, y que presentan un resultado negativo de la prueba de embarazo en suero en la visita de selección.
    Si así lo indica el investigador, los pacientes deben estar dispuestos a no conducir un vehículo (si sufren somnolencia al volante) o maquinaria pesada durante todo el estudio o hasta que el investigador lo considere clínicamente indicado. Asimismo, los pacientes deben estar dispuestos a mantener durante el estudio los comportamientos habituales que podrían afectar a la somnolencia diurna (p. ej., ritmo circadiano, consumo de cafeína, duración del sueño nocturno).
    Pacientes que hayan firmado y fechado un consentimiento informado.
    E.4Principal exclusion criteria
    Los pacientes no deben presentar ninguno de los criterios siguientes:
    Pacientes que padezcan insomnio crónico grave de acuerdo con la Clasificación internacional de trastornos del sueño (ICSD 2005) sin SAOS.
    Pacientes con narcolepsia (ICSD 2005) concomitante según criterios clínicos.
    Pacientes con carencia de sueño no debida a SAOS (a criterio del médico).
    Pacientes con fragmentación del sueño que no tenga origen respiratorio (síndrome de piernas inquietas).
    Trabajo a turnos, conductores profesionales.
    Negativa del paciente a suspender cualquier tratamiento actual contra la somnolencia diurna excesiva o riesgos predecibles del paciente de suspender el tratamiento.
    Pacientes con enfermedad psiquiátrica.
    Enfermedad aguda o crónica que impida la evaluación de la mejora (EPOC grave).
    Abuso actual o reciente (en el plazo de 1 año) de drogas, alcohol, narcóticos u otras sustancias o dependencia.
    Cualquier anomalía grave significativa del sistema cardiovascular, p. ej., infarto de miocardio reciente, angina de pecho, hipertensión o disritmias (en los 6 meses anteriores), intervalo de QT corregido de Bazett en el electrocardiograma superior a 450 ms, antecedentes de hipertrofia ventricular izquierda o prolapso de la válvula mitral.
    Afección médica o biológica concomitante que pueda obstaculizar la participación en el estudio según el investigador (en concreto, del sistema cardiovascular y diabetes inestable).
    Pruebas serológicas positivas (VHC, HBsAg y, opcionalmente, VIH).
    Mujeres embarazadas o en período de lactancia.
    Mujeres en edad fértil que no utilizan un método anticonceptivo eficaz.
    Pacientes incapaces de comprender el protocolo del estudio.
    Pacientes con hipersensibilidad sospechada o comprobada a la medicación del estudio.
    Pacientes con deficiencia en el brazo dominante que les impide realizar las pruebas.
    Pacientes que utilizan un tratamiento prohibido.
    Intolerancia congénita a la galactosa, malabsorción de glucosa-galactosa, deficiencia de lactasa (lactosa en placebo).
    Pacientes que participen en otro estudio o que se encuentren en un período de seguimiento de otro estudio.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio principal de valoración de la eficacia se basa en la puntuación de la escala de somnolencia de Epworth (ESS). Se compararán las medias obtenidas en la escala ESS en V5 y V6 (fin del periodo doble ciego) con la media obtenida en V1 y V2 (periodo basal).
    Se llevará a cabo un análisis de superioridad entre BF2.649 y placebo.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    Ver protocolo
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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 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) Yes
    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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 280
    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 Decision2011-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
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