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    Summary
    EudraCT Number:2011-000084-27
    Sponsor's Protocol Code Number:P10-01/BF2.649
    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:2012-11-12
    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 number2011-000084-27
    A.3Full title of the trial
    DOUBLE BLIND RANDOMIZED STUDY TO ASSESS THE EFFICACY OF BF2.649 COMPARED TO PLACEBO IN ADD-ON TO SODIUM OXYBATE IN THE TREATMENT OF NARCOLEPTIC PATIENTS WITH RESIDUAL EXCESSIVE DAYTIME SLEEPINESS (EDS) DURING 8 WEEKS.
    Estudio randomizado doble ciego para evaluar la eficacia del BF2.649 en comparación con el placebo agregado al oxibato de sodio en el tratamiento de pacientes narcolépticos con somnolencia diurna excesiva (SDE) residual durante 8 semanas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DOUBLE BLIND RANDOMIZED STUDY TO ASSESS THE EFFICACY OF BF2.649 COMPARED TO PLACEBO IN ADD-ON TO SODIUM OXYBATE IN THE TREATMENT OF NARCOLEPTIC PATIENTS WITH RESIDUAL EXCESSIVE DAYTIME SLEEPINESS (EDS) DURING 8 WEEKS.
    Estudio randomizado doble ciego para evaluar la eficacia del BF2.649 en comparación con el placebo agregado al oxibato de sodio en el tratamiento de pacientes narcolépticos con somnolencia diurna excesiva (SDE) residual durante 8 semanas.
    A.3.2Name or abbreviated title of the trial where available
    HARMONY IV
    A.4.1Sponsor's protocol code numberP10-01/BF2.649
    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 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 supportBioprojet
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioprojet
    B.5.2Functional name of contact pointBioprojet clinical department
    B.5.3 Address:
    B.5.3.1Street Address9 rue Rameau
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75002
    B.5.3.4CountryFrance
    B.5.4Telephone number+3301 47 03 66 33
    B.5.5Fax number+3301 47 03 66 30
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/459
    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 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 INNPitolisant
    D.3.9.1CAS number 903576-44-3
    D.3.9.2Current sponsor codeBF2.649
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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) 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
    Narcolepsy
    Narcolepsia
    E.1.1.1Medical condition in easily understood language
    narcoleptic patients with residual Excessive Daytime Sleepiness (EDS)
    Pacientes narcolepticos con somnolencia diurna excesiva (SDE) residual
    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 LLT
    E.1.2Classification code 10048322
    E.1.2Term Narcolepsy aggravated
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028713
    E.1.2Term Narcolepsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10007737
    E.1.2Term Cataplexy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10048323
    E.1.2Term Cataplexy aggravated
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10028715
    E.1.2Term Narcolepsy with cataplexy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To show relevant beneficial effect of BF2.649 on EDS compared to placebo in add on to sodium oxybate in narcoleptic patients with residual EDS.
    This trial will characterize the efficacy of BF2.649 compared to placebo in showing an incremental improvement to the situation achieved by the use of sodium oxybate particularly in terms of a reduction of EDS as measured by the Epworth Sleepiness scale (ESS). In addition the change in the average number of cataplexy attacks per week will be assessed.
    Mostrar el efecto beneficioso relevante del BF2.649 en la SDE en comparación
    con el placebo agregado al oxibato de sodio en pacientes narcolépticos con SDE
    residual. Este ensayo caracterizará la eficacia del BF2.649 en comparación con
    el placebo al mostrar una mejora creciente de la situación que se logra mediante
    el uso del oxibato de sodio, especialmente en términos de una reducción de la
    SDE, medida por la Escala de somnolencia de Epworth (ESS). Además, se
    evaluará el cambio en la cantidad promedio de ataques de cataplejía por
    semana.
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Males or females, aged 18 years old and over.
    ? Patients with a diagnosis of narcolepsy according to the International Classification of Sleep Disorders (ICSD-2) criteria
    ? Patients treated with sodium oxybate (Xyrem®) with a stable dosage for at least 2 months prior to the trial.
    ? Patients complaining of residual EDS with an ESS score ? 12
    ? Patient should be free of non authorized drugs or discontinue any psychostimulant medication at least 3 weeks before randomization (V2).
    ? Females of child-bearing potential must use a medically accepted effective method of birth control, agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding patient.
    ? In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g. transportation to and from trial site, self rating scales, drug compliance, scheduled visits, etc).
    ? Patient must have voluntarily expressed a willingness to participate in this study, signed and dated an informed consent prior to beginning this protocol required procedures.
    · Hombres y mujeres mayores de 18 años.
    · Pacientes con diagnóstico de narcolepsia según los criterios de la
    Clasificación Internacional de los Trastornos del Sueño (ICSD-2).
    · Pacientes tratados con oxibato de sodio (Xyrem®), con una dosis
    estable durante al menos 2 meses antes del estudio.
    · Pacientes que se quejan de SDE residual con una puntuación ESS ≥ 12.
    · El paciente debe estar libre de fármacos no autorizados o interrumpir
    cualquier medicamento psicoestimulante por lo menos 3 semanas antes de
    la randomización (V2).
    · Las mujeres en edad de procrear deben utilizar un método anticonceptivo
    eficaz aceptado médicamente, comprometerse a seguir con el método
    durante el estudio y dar negativo en la prueba de embarazo en suero
    realizada en la consulta de selección. Las pacientes mujeres no deben estar
    amamantando.
    · En opinión del investigador, el paciente debe tener un apoyo adecuado para
    cumplir con todos los requisitos del estudio según se describen en el
    protocolo (por ejemplo, el transporte hacia y desde el sitio del estudio, las
    escalas de autoevaluación, el cumplimiento con los medicamentos, las
    visitas de consulta programadas, etc.).
    · El paciente debe haber expresado voluntariamente su disposición a
    participar en este estudio, y firmado y fechado el consentimiento informado
    antes de iniciar estos procedimientos requeridos por el protocolo.
    E.4Principal exclusion criteria
    ? Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as moderate or severe psychosis or dementia, bipolar illness, severe anxiety, clinical severe depression (BDI ? 16) with suicidal risk (item G BDI > 0), or depression treated for less than 8 weeks, history of seizure disorder or other problem that in the investigator?s opinion would preclude the patient?s participation and completion of this trial or comprise reliable representation of subjective symptoms.
    ? Patients working in an occupation requiring variable shift work or routine night shifts.
    ? Patients with an untreated sleep apnea disorder (defined as an apnea index > 10/h or an apnea/hypopnea index>15/h) or who have any other cause of daytime sleepiness.
    ? Use of hypnotics, tranquilizers, sedating antihistamines, psychostimulants for the treatment of EDS (amphetamine and amphetamine-like CNS stimulants, modafinil, methylphenidate or others), benzodiazepines, anticonvulsants or clonidine will not be accepted at least 3 weeks before randomization (V2) and during study.
    ? Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
    ? Other active clinically significant illness, including unstable cardiovascular, or neoplasic pathology which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study participation.
    ? Patient with a known history of long QTc syndrome (e.g. syncope or arythmia) or presenting any significant serious abnormality of the ECG (e.g. recent myocardial infarction), or QTc interval strictly higher than 450 ms (electrocardiogram Bazett?s corrected QT interval (QT x ? [HR/60]).
    ? Patients with Severe Hepatic Impairment or with Severe Renal Impairment, or with any other significant abnormality in the physical examination or clinical laboratory results.
    ? Known hypersensitivity to the tested treatment including active substance and excipients.
    ? Patients participating in an other study and the use of any investigational therapy within the 30 days prior to the entry in this study.
    ? Patient without any medical care insurance
    · Trastornos psiquiátricos y neurológicos (excepto narcolepsia o cataplejía),
    como psicosis o demencia moderada o grave, enfermedad bipolar, ansiedad
    severa, depresión clínica severa (BDI ≥ 16) con riesgo de suicidio (elemento
    G BDI > 0), o depresión tratada durante menos de 8 semanas, antecedentes
    de convulsiones o cualquier otro problema que, en opinión del investigador,
    imposibilita la participación del paciente y la realización de este estudio, o
    que constituye una representación confiable de los síntomas subjetivos.
    · Pacientes que trabajan en una ocupación que requiere trabajar en turnos
    variables o turnos rutinarios de noche.
    · Pacientes con un trastorno sin tratamiento de apnea del sueño (definido
    como un índice de apnea > 10/h o un índice de apnea/hipopnea >15/h) o que
    tengan cualquier otra causa de somnolencia diurna.
    · El uso de hipnóticos, tranquilizantes, antihistamínicos sedantes,
    psicoestimulantes para el tratamiento de la SDE (anfetaminas y similares
    que estimulan el SNC, modafinilo, metilfenidato u otros), benzodiacepinas,
    anticonvulsivos o clonidina no se aceptarán por lo menos 3 semanas antes de la randomización (V2) ni durante el estudio.
    · Antecedentes actuales o recientes (de un año o menos) de abuso de
    sustancias o trastorno de dependencia, incluyendo el abuso de alcohol, tal
    como se define en el Manual Diagnóstico y Estadístico de los Trastornos
    Mentales (DSM-IV).
    · Otra enfermedad activa clínicamente significativa, incluyendo patología
    neoplásica o cardiovascular inestable que pudiese interferir con la realización
    del estudio o contraindicar los tratamientos del estudio, o colocar al paciente
    en situación de riesgo durante la prueba o poner en peligro la participación
    en el estudio.
    · Paciente con antecedentes conocidos de síndrome de QTc largo (por
    ejemplo, síncope o arritmia) o que presenta cualquier anomalía significativa
    grave del ECG (por ejemplo, infarto de miocardio reciente) o intervalo QTc
    estrictamente superior a 450 ms (intervalo QT corregido de Bazett en el
    electrocardiograma (QT x √[HR/60])).
    · Pacientes con insuficiencia hepática grave o con insuficiencia renal grave, o
    con cualquier otra anomalía significativa en el examen físico o en los
    resultados clínicos de laboratorio.
    · Hipersensibilidad conocida al tratamiento probado, incluyendo sustancia
    activa y excipientes.
    · Pacientes que participan en otro estudio y el uso de cualquier terapia de
    investigación dentro de los 30 días previos al ingreso a este estudio.
    · Paciente sin ningún tipo de seguro de atención médica.
    E.5 End points
    E.5.1Primary end point(s)
    The primary measure of efficacy will be the changes in Excessive Daytime Sleepiness (EDS) as measured by the Epworth Sleepiness scale (ESS), and based on the change from baseline (average V1 and V2) of the score of ESS (average V5 and V6).
    La principal medida de eficacia serán los cambios en la somnolencia diurna excesiva (SDE) medidos por la Escala de somnolencia de Epworth (ESS), y basándose en el cambio a partir del inicio (promedio V1 y V2) de la puntuación
    de la ESS (promedio V5 y V6).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study.
    Durante todo el estudio.
    E.5.2Secondary end point(s)
    ? Changes in EDS as measured by the Maintenance of Wakefulness Test (MWT), four sessions of 40-minute tests
    ? Number of sleep attacks and sleepiness episodes (as recorded in patient diaries),
    ? Changes in the average number of cataplexy attacks per week (as recorded in patient diaries) between the 2-week baseline (V1-V2) and the 4-week stable treatment period (V4-V6),
    ? Severity of EDS measured by the Clinical Global Impression of Change and of Severity (CGI-C and CGI-S on EDS)
    ? Severity of cataplexy measured by the Clinical Global Impression of Change and of Severity (CGI-C and CGI-S on cataplexy)
    ? European Quality of life questionnaire (EQ-5D)
    ? Patient?s Global Opinion on effect of treatment
    ? Tolerability as measured by Treatment Emergent Adverse Events (TEAE), Changes in Physical examination and Vital signs
    ? Withdrawal symptoms assessed by DSM IV questionnaire
    · Cambios en la SDE, medidos con la Prueba de mantenimiento de la vigilia
    (MWT), pruebas en cuatro sesiones de 40 minutos.
    · El número de ataques de sueño y episodios de somnolencia (según consta
    en los diarios del paciente).
    · Cambios en el número promedio de ataques de cataplejía por semana
    (según consta en los diarios del paciente) entre la línea de base (inicio) de 2
    semanas (V1-V2) y el período de 4 semanas de tratamiento estable (V4-V6).
    · La gravedad de la SDE medida por la Impresión Clínica Global de Cambio y
    de Gravedad (CGI-C y CGI-S en la SDE).
    · La gravedad de la cataplejía medida por la Impresión Clínica Global de
    Cambio y de Gravedad (CGI-C y CGI-S en la cataplejía).
    · European Quality of Life Questionnaire (Cuestionario Europeo sobre Calidad
    de Vida) (EQ-5D).
    · Opinión global del paciente sobre el efecto del tratamiento.
    · Tolerabilidad medida por los acontecimientos adversos surgidos durante el
    tratamiento (TEAE), los cambios en el examen físico y los signos vitales.
    · Síntomas de abstinencia evaluados con el cuestionario DSM IV.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated after 14 days, 28 days, 49 days and 56 days double blind treatment and one week placebo follow-up.
    El criterio de valoración principal serán evaluados después de 14 días, 28 días, 49 días y 56 días de tratamiento doble ciego y una semana de placebo seguido.
    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) 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 Yes
    E.8.1.7.1Other trial design description
    one additional placebo week single blind for each patient treated by PR1 for 8 weeks
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    The last visit of the last subject.
    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: 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Neither specific treatment or care after the patient participation in the
    trial are expected. It is assumed that the subject will be treated
    according to the usual physician clinical practice.
    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 Decision2013-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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