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    Summary
    EudraCT Number:2010-023963-16
    Sponsor's Protocol Code Number:1014802/202
    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:2013-02-04
    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 number2010-023963-16
    A.3Full title of the trial
    A Phase IIa Placebo-Controlled, Double-Blind Randomised Withdrawal Study to Evaluate the Safety and Efficacy of CNV1014802 in Patients with Trigeminal Neuralgia.
    Estudio de fase IIa, controlado con placebo, de retirada aleatorizada y con doble enmascaramiento, para evaluar la seguridad y la eficacia de CNV1014802 en pacientes con neuralgia del trigémino.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the effect of a drug called CNV1014802 on intense face pain and how safe the drug is.
    Un ensayo clínico para investigar el efecto de un fármaco llamado CNV1014802 en dolor intenso cara y cómo la caja fuerte es la droga.
    A.4.1Sponsor's protocol code number1014802/202
    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 SponsorConvergence Pharmaceuticals Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportConvergence Pharmaceuticals Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConvergence Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressMaia Building, Babraham Research Campus
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB22 3AT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)123 755501
    B.5.5Fax number+44 (0)1223 497114
    B.5.6E-mailinfo@convergencepharma.com
    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 nameCNV1014802
    D.3.2Product code CNV1014802
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNCNV1014802
    D.3.9.3Other descriptive nameCNV1014802
    D.3.9.4EV Substance CodeSUB32074
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboFilm-coated tablet
    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
    Trigeminal Neuralgia
    Neuralgia del trigémino
    E.1.1.1Medical condition in easily understood language
    Intense Face Pain
    Dolor facial intenso.
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10029227
    E.1.2Term Neuralgia trigeminal
    E.1.2System Organ Class 100000004852
    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 the effect of repeat oral dosing of CNV1014802 on the pain experienced in trigeminal neuralgia.
    Investigar el efecto de la administración oral repetida de CNV1014802 sobre el dolor sufrido en la neuralgia del trigémino.
    E.2.2Secondary objectives of the trial
    - To investigate the safety and tolerability of CNV1014802 in patients with trigeminal neuralgia
    - To assess the plasma concentrations and exposures of CNV1014802
    - To assess the use of the Brief Pain Inventory - Facial as an assessment measure for quality of life in trigeminal neuralgia
    - Investigar la seguridad y la tolerabilidad del CNV1014802 en pacientes con neuralgia del trigémino.
    - Evaluar las concentraciones plasmáticas y los valores de exposición del CNV1014802.
    - Evaluar el uso del Inventario breve de dolor - Facial (Brief Pain Inventory - Facial) como medida para valorar la calidad de vida en los pacientes con neuralgia del trigémino.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -IHS criteria for trigeminal neuralgia to be used. The diagnosis must be verified by a member of the diagnostic sub-committee of the Data Monitoring Committee before the patient is entered into the study.
    -A diagnosis of trigeminal neuralgia - Pain must be unilateral, and characterized by brief electric shock-like pains, abrupt in onset and termination, limited to the distribution of one or more divisions of the trigeminal nerve. Pain is commonly evoked by trivial stimuli including washing, shaving, smoking, talking and/or brushing the teeth(trigger factors), and frequently occurs spontaneously. The attacks start and end rapidly. There is often no pain between each bout of pain and many bouts can occur every day. There is often a refractory period between attacks. Some patients may report some after pain after the severe pain for a few minutes. Pain remissions occur where there can be weeks or months of no pain even when medications are stopped.
    -The following diagnostic criteria for trigeminal neuralgia must be met:
    -Paroxysmal attacks of pain lasting from a fraction of a second to 2 minutes, affecting one or more divisions of the trigeminal nerve and fulfilling criteria b and c.
    -Pain has at least one of the following characteristics:
    i. Intense, sharp, superficial or stabbing
    ii. Precipitated from trigger areas or by trigger factors
    -Attacks are stereotyped in the individual patient
    -There is no clinically evident neurological deficit
    -Not attributed to another disorder
    -Frequency criteria for numbers of paroxysms:
    -Patients must have suffered a minimum of 3 or more paroxysms of pain per day, rated at an intensity of 4 or more on the pain NRS, on at least 4 days during the last 7 days prior to entry into the open-label treatment period.
    -Male or female between 18 and 80 years of age inclusive, at the time of signing the informed consent.
    -A female patient is eligible to participate if she is of:
    -Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >/= 25.8 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study.
    -Child-bearing potential and agrees to use one of the contraception methods listed for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female patients must agree to use contraception until 3 days post-last dose.
    -Male patients must agree to use one of the contraception methods listed.
    This criterion must be followed from the time of the first dose of study medication until 14 days post-last dose.
    -Body weight >/=50 kg for men and >/=45 kg for women.
    -BMI </=34.9.
    -Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Informed consent must be obtained prior to the commencement of any study related procedures.
    -Three ECGs taken at least 5 min apart should be performed at Screening. QTcF < 450 msec in at least two of the three ECGs .
    -AST and ALT < 2xULN; alkaline phosphatase and bilirubin </=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    -Approved concomitant medications must have been stable for at least 3 weeks prior to day 0.
    -Se utilizarán los criterios de la Sociedad Internacional de Cefaleas (IHS, International Headache Society) para el diagnóstico de la neuralgia del trigémino. Un miembro del subcomité de diagnóstico del DMC deberá verificar el diagnóstico antes de que el paciente entre en el estudio.
    -Diagnóstico de neuralgia del trigémino. El dolor debe ser unilateral y se caracteriza por ser como una sacudida eléctrica de breve duración, que comienza y termina de manera abrupta, y se limita a la distribución de una o más ramas del trigémino. Por lo común, el dolor se desencadena con estímulos insignificantes, como lavarse, afeitarse, fumar, hablar o lavarse los dientes (factores desencadenantes), y con frecuencia se produce espontáneamente. Las crisis comienzan y terminan rápidamente. A menudo no hay dolor entre los episodios y pueden producirse numerosos episodios en un día. Con frecuencia hay un periodo refractario entre las crisis. Algunos pacientes refieren un dolor residual durante unos minutos después del dolor intenso. Se producen remisiones del dolor, de forma que pueden transcurrir semanas o meses sin dolor, incluso tras la suspensión de la medicación.
    -Deben cumplirse los siguientes criterios diagnósticos de neuralgia del trigémino:
    -Crisis paroxísticas de dolor, con una duración desde una fracción de segundo hasta 2 minutos, que afecta a una o más ramas del trigémino y cumple los criterios b y c.
    -El dolor presenta por lo menos una de las siguientes características:
    i.Intenso, agudo, superficial o punzante
    ii.Precipitado en zonas gatillo o por factores desencadenantes
    -Las crisis son estereotipadas en cada paciente
    -No hay indicios clínicos de déficit neurológico
    -No se atribuye a ningún otro trastorno
    -Criterios relativos a la frecuencia del número de paroxismos:
    -Los pacientes deben haber sufrido un mínimo de 3 paroxismos de dolor al día, con una puntuación igual o superior a 4 en la escala de calificación numérica (NRS) de intensidad del dolor, por lo menos en 4 días durante los últimos 7 días antes de la entrada en el periodo de tratamiento abierto.
    -Varones o mujeres de 18 a 80 años de edad, ambos extremos incluidos, en el momento de la firma del consentimiento informado.
    -Una mujer será elegible para participar si:
    -No es potencialmente fértil, lo que se define como mujeres premenopáusicas con ligadura de trompas o histerectomía documentadas; o posmenopáusicas, lo que se define como 12 meses de amenorrea espontánea [los casos dudosos quedan confirmados mediante un análisis de sangre con unos resultados de hormona foliculoestimulante (FSH) >/= 25.8 MUI/mL y estradiol < 40 pg/mL (< 140 pmol/L), simultáneamente]. Las mujeres en tratamiento hormonal sustitutivo y cuyo estado de menopausia sea dudoso deberán utilizar uno de los métodos anticonceptivos señalados si desean continuar su tratamiento hormonal sustitutivo durante el estudio.
    -Es potencialmente fértil y se compromete a utilizar uno de los métodos anticonceptivos que se enumeran durante un plazo de tiempo adecuado (determinado según la ficha técnica del producto o a juicio del investigador) antes de comenzar el tratamiento, de forma que el riesgo de embarazo se haya reducido lo suficiente en ese momento. Las mujeres deben comprometerse a utilizar métodos anticonceptivos hasta 3 días después de la última dosis.
    -Los pacientes varones deben comprometerse a utilizar uno de los métodos anticonceptivos que se enumeran. Este criterio debe seguirse desde el momento de la primera dosis de la medicación del estudio hasta 14 días después de la última dosis.
    -Peso corporal >/= 50 kg en el caso de los varones y >/= 45 kg en el caso de las mujeres.
    -Índice de masa corporal </=34.9
    -apaz de otorgar su consentimiento informado por escrito, lo que incluye el cumplimiento de los requisitos y restricciones enumerados en el documento de consentimiento. Deberá obtenerse el consentimiento informado antes de comenzar cualquier procedimiento relacionado con el estudio.
    -En la selección se realizarán tres ECG, obtenidos con una separación mínima de 5 minutos. QTcF < 450 ms en al menos dos de los tres ECG.
    -AST y ALT < 2 × ULN; fosfatasa alcalina y bilirrubina </= 1.5 × ULN (se aceptan valores aislados de bilirrubina > 1.5 × ULN si esta se ha fraccionado y la bilirrubina directa es < 35 %).
    -Los medicamentos concomitantes aprobados deben haberse mantenido estables desde por lo menos 3 semanas antes del Día 0.
    E.4Principal exclusion criteria
    -Patients who are known non-responders to sodium channel blockers at therapeutic doses.
    -Patients taking the following medication: carbamazepine, lamotrigine, mexiletine, valproate, lidocaine, lacosamide, amitriptyline, topiramate or other known or hypothesised sodium channel blockers.
    -Patients with causes for their facial pain other than that specified in Inclusion Criterion
    -A positive pre-study drug screen.
    -A positive history of HIV.
    -A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
    -History of any liver disease within the last 6 months, with the exception of known Gilbert's disease.
    -History of excessive regular alcohol consumption within 6 months of the study
    -Patients with a history or risk of seizures or a history of epilepsy, head injury or related neurological disorders.
    -Patients with a history of uncontrolled or poorly controlled hypertension, with systolic BP frequently exceeding 160mmHg and/or diastolic BP frequently exceeding 100mmHg, or patients who have BP greater than or equal to 160mmHg systolic and/or greater than or equal to 100mmHg diastolic at screening after repeated measurements.
    -History or presence of significant cardiovascular, gastro-intestinal, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
    -Patients with conditions known to affect cardiac conduction or a personal or familial history of Brugada syndrome.
    -Pregnant females as determined by positive urine or serum hCG test at screening or prior to dosing.
    -Lactating females.
    -History or presence of any clinically significant abnormality in vital signs/ECG/ laboratory tests or have any medical or psychiatric condition, which may interfere with the study procedures or compromise patient safety.
    -Patient has a history of suicidal ideation and/or suicide attempts.
    -Patient has clinical evidence of recent major depression.
    -Changes to medications for the treatment of neuropathic pain that are permitted within the study within 3 weeks of the start of open-label (Day 0), including dose adjustment, withdrawal of medications or initiation of new medications. Patients must be able to maintain the medications at stable dose during the study
    -Unable to refrain from excessive use of sedative medications
    -Use of other prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John,s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of open-label study medication (Day 0) or during the study, that may interfere with the study procedures or compromise patient safety or introduce a risk of drug-drug interactions. This includes but is not limited to:

    -Patients taking the following medication: lamotrigine, carbamazepine, mexiletine, valproate, lidocaine, lacosamide, amitriptyline, topiramate or other known or hypothesised sodium channel blockers.
    -Patients taking medications that may adversely interact with a monoamine oxidase-B inhibitor: Antidepressants such as the tricyclics, selective serotonin reuptake inhibitors (SSRIs), serotonin and noradrenaline reuptake inhibitors (SNRIs), trazodone, lithium, tryptophan, opioids, and sympathomimetic agents. Concomitant use with all monoamine oxidase inhibitors is prohibited
    -History of hypersensitivity to CNV1014802
    -The patient has participated in a clinical trial and has received an investigational product within the following time period prior to screening in the current study: 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
    -Exposure to more than four new chemical entities within 12 months prior to the first dosing day
    -Where participation in the study would result in total donation of blood or blood products in excess of 500mL within a 56 day period
    -Patient is mentally or legally incapacitated
    -Unwillingness or inability to follow the procedures outlined in the protocol
    -Pacientes con falta de respuesta a bloqueantes de los canales de sodio en dosis terapéuticas
    -Pacientes en tratamiento con los siguientes medicamentos: carbamazepina, lamotrigina, mexiletina, valproato, lidocaína, lacosamida, amitriptilina, topiramato u otros productos con efecto conocido o supuesto de bloqueo de los canales de sodio
    -Pacientes con causas de dolor facial distintas de las especificadas en el criterio de inclusión.
    -Resultado positivo de detección de drogas antes del estudio
    -Antecedentes de positividad para el virus de la inmunodeficiencia humana
    -Resultado positivo para el antígeno de superficie del virus de la hepatitis B antes del estudio o resultado positivo para anticuerpos contra el virus de la hepatitis C en el plazo de los 3 meses anteriores a la selección
    -Antecedentes de cualquier hepatopatía en el plazo de los últimos 6 meses, con excepción de la enfermedad de Gilbert
    -Antecedentes de un consumo habitual excesivo de alcohol en el plazo de los 6 meses anteriores al estudio
    -Pacientes con antecedentes o riesgo de crisis comiciales o antecedentes de epilepsia, traumatismo craneoencefálico o trastornos neurológicos relacionados
    -Pacientes con antecedentes de hipertensión no controlada o mal controlada, con una presión arterial sistólica que sobrepase con frecuencia los 160 mm Hg y/o una presión arterial diastólica que sobrepase con frecuencia los 100 mm Hg, o pacientes con una presión arterial mayor o igual que 160 mm Hg de sistólica y/o mayor o igual que 100 mm Hg de diastólica en la selección, tras mediciones repetidas
    -Antecedentes o presencia de trastornos importantes de tipo cardiovascular, gastrointestinal o renal, u otros trastornos con efecto conocido de interferencia en la absorción, distribución, metabolismo o eliminación de los fármacos
    -Pacientes con trastornos con efecto conocido sobre la conducción cardiaca, o con antecedentes personales o familiares de síndrome de Brugada
    -Mujeres embarazadas, determinado mediante un resultado positivo en una prueba de la hCG en orina o suero en la selección o antes del tratamiento
    -Mujeres en periodo de lactancia
    -Antecedentes o presencia de cualquier alteración clínicamente importante de las constantes vitales, el ECG o las pruebas analíticas de laboratorio, o con algún trastorno médico o psiquiátrico que, pudieran influir en los procedimientos del estudio o comprometer la seguridad del paciente
    -Paciente con antecedentes de ideas y/o intentos de suicidio
    -Paciente con evidencia clínica de depresión mayor reciente
    -Cambio a medicamentos para el tratamiento del dolor neuropático que se permiten en el estudio en las 3 semanas anteriores al comienzo del periodo abierto (Día 0), lo que incluye el ajuste de la dosis, la retirada de medicamentos o el inicio de medicamentos nuevos. Los pacientes deben ser capaces de mantener una dosis estable de los medicamentos durante el estudio
    -Incapacidad de evitar el uso excesivo de sedantes
    -Uso de otros fármacos de venta con o sin receta, incluidas vitaminas, plantas medicinales y suplementos dietéticos (incluido el hipérico) en el plazo de 7 días (o 14 días si el fármaco es un posible inductor enzimático) o 5 semividas (eligiéndose el plazo mayor) antes de la primera dosis de la medicación del estudio administrada de manera abierta (Día 0) o durante el estudio, que pudiera influir en los procedimientos del estudio, comprometer la seguridad del paciente o suponer un riesgo de interacciones medicamentosas. Se incluyen, entre otros:

    -Pacientes en tratamiento con los siguientes medicamentos: lamotrigina, carbamazepina, mexiletina, valproato, lidocaína, lacosamida, amitriptilina, topiramato u otros productos con efecto conocido o supuesto de bloqueo de los canales de sodio.
    -Pacientes en tratamiento con medicamentos que puedan ejercer interacciones adversas con un inhibidor de la monoaminoxidasa B: antidepresivos como los tricíclicos, inhibidores selectivos de la recaptación de serotonina (ISRS), inhibidores de la recaptación de noradrenalina y serotonina (IRNS), trazodona, litio, triptófano, opiáceos y simpaticomiméticos. Se prohíbe el uso concomitante en cualquier inhibidor de la monoaminoxidasa.
    -Antecedentes de hipersensibilidad al CNV1014802
    -Paciente que ha participado en un ensayo clínico y ha recibido un producto en fase de investigación dentro del siguiente periodo antes de la selección del presente estudio: 5 semividas o el doble de la duración del efecto biológico del producto en fase de investigación (eligiéndose el plazo mayor)
    -Exposición a más de cuatro entidades químicas nuevas en el plazo de los 12 meses anteriores al primer día de tratamiento
    -Circunstancias en las que la participación en el estudio supondría la donación de un total de sangre o hemoderivados superior a 500 mL en un periodo de 56 días
    -Paciente que está mental o legalmente incapacitado
    -Paciente que no está dispuesto o es incapaz de seguir los procedimientos señalados en el protocol
    E.5 End points
    E.5.1Primary end point(s)
    Patients will be classified as a treatment failure if they meet one of the following criteria:
    i. 50% increase in the frequency of paroxysms compared to the final 7 days of the open-label period
    ii. 50% increase in the severity of pain experienced in the paroxysms compared to the final 7 days of the open-label period
    iii. A Patient Global Improvement of Change rating of much worse/very much worse
    iv. The patient discontinues the study due to Lack of Efficacy.
    v. The patient discontinues due to an adverse reaction or poor tolerability considered to be related to study medication
    Se clasificará a los pacientes como fracaso del tratamiento si cumplen uno de los criterios siguientes:
    i. Aumento del 50 % en la frecuencia de paroxismos en comparación con los últimos 7 días del periodo abierto.
    ii. Aumento del 50 % en la intensidad del dolor sufrido en los paroxismos en comparación con los últimos 7 días del periodo abierto.
    iii. Valoración de mucho peor/muchísimo peor en la Impresión global de cambio por el paciente.
    iv. El paciente abandona el estudio por falta de eficacia.
    v. El paciente abandona el estudio por una reacción adversa o escasa tolerabilidad que se consideren relacionadas con la medicación del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The frequency and the severity of paroxysms will be recorded on a daily basis by the patient. The patient and clinical global impression of change rating will be determined on Day 21 and 49.
    La frecuencia y la gravedad de los paroxismos se graba en una base diaria por parte del paciente. La impresión global del paciente y clínico de Puntuación de cambio se determinará en el día 21 y 49.
    E.5.2Secondary end point(s)
    Efficacy Endpoints :
    - Number and severity of paroxysms of pain in the 21 day open-label period
    - Average 24 hour pain intensity numerical rating scale (PI-NRS)
    - Patient and Physician Clinical Global Impression of Change
    - Brief Pain Inventory - Facial

    Pharmacokinetics:
    - Pre-dose and post-dose plasma CNV1014802 concentrations - AUC-ss, Ctrough-ss and Cmax-ss

    Safety:
    - Adverse events
    - Vital signs
    - ECG parameters
    - Laboratory safety tests (clinical chemistry, haematology, urinalysis)

    Exploratory Endpoints:
    - Assessing PK-PD relationship, if data permit.
    - Cognitive function using the Medical Outcome Study - Cognitive Scale
    - Adverse event profile (AEP) scale
    Criterios de valoración de la eficacia:
    - Número e intensidad los paroxismos de dolor en el periodo abierto de 21 días.
    - Promedio de 24 horas en la escala de calificación numérica de intensidad del dolor (PI-NRS).
    - Impresión global de cambio por el paciente y por el médico.
    - Inventario breve de dolor - Facial.

    Farmacocinética:
    - Concentraciones plasmáticas de CNV1014802 antes y después de la dosis: AUC ss, Ctrough ss y Cmax ss.

    Seguridad:
    - Acontecimientos adversos.
    - Constantes vitales.
    - Parámetros electrocardiográficos.
    - Pruebas analíticas de seguridad (bioquímica sérica, hemograma, análisis de orina).

    Criterios de valoración exploratorios:
    - farmacodinámicas, si los datos lo permiten.
    - Función cognitiva según la escala MOS-Cog (Medical Outcome Study - Cognitive Scale).
    - Escala del perfil de acontecimientos adversos (AEP).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The frequency and the severity of paroxysms will be recorded on a daily basis by the patient. The patient and clinical global impression of change rating will be determined on Day 21 and Day 49. The brief pain inventory - facial will be determined on Day 0, 21, 49 and 56. Pharmacokinetics will be assessed on Day 0, 7, 21, 35 and 49. Vital signs and ECGs will be assessed on Day 0, 7, 14, 21, 28, 35, 42, 49 and 56. Laboratory safety samples will be taken in screening and on Day 0, 7, 21, 35, 49 and 56. Cognitive status will be assessed on Day 0, 21 and 49. Adverse events profile scale will be determined in screening and on Day 21 and 49. Adverse events will be collected throughout.
    La frecuencia y la gravedad de los paroxismos se graba en una base diaria por parte del paciente. La impresión global del paciente y clínico de Puntuación de cambio será determinado en el Día 21 y el Día 49. El Brief Pain Inventory - facial se determinará el día 0, 21, 49 y 56. Farmacocinética Se evaluó en el día 0, 7, 21, 35 y 49. Los signos vitales y ECG se evaluó en el día 0, 7, 14, 21, 28, 35, 42, 49 y 56. De laboratorio muestras de seguridad se tomarán en el cribado y en el día 0, 7, 21, 35, 49 y 56. El estado cognitivo se evaluó en el día 0, 21 y 49. Escala adverso perfil de eventos se determinarán en el cribado y en el día 21 y 49. Los eventos adversos se recogieron a lo largo de.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Pacientes inician estudio abierto y si responden al fármaco en estudio pasan a la fase a doble ciego
    All patients start in open label and if they respond to study drug they enter the double-blind phase
    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 EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    South Africa
    Switzerland
    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
    LVLS
    LVLS
    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 months0
    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 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.1.1.1In 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 40
    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)
    Patient will revert back to their initial treatments or may opt for surgical management after completion of the study because this test drug is not approved for treatment of trigeminal neuralgia.
    Tras la conclusión del estudio, el paciente volverá a sus fármacos iniciales o podrá optar por el tratamiento quirúrgico, ya que este fármaco no está aprobado para el tratamiento de la neuralgia del trigémino.
    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 Decision2013-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
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