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    Summary
    EudraCT Number:2015-001769-14
    Sponsor's Protocol Code Number:LACO15
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-26
    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 number2015-001769-14
    A.3Full title of the trial
    Analgesic efficacy of intravenous lacosamide administered perioperatively for thoracic surgery with thoracotomy approach.
    Eficacia analgésica de lacosamida endovenosa administrada en el perioperatorio de cirugía de tórax con abordaje por toracotomía.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antiepileptic drug for the management of acute pain posthoracotomy
    Antiepiléptico para el manejo del dolor agudo postoracotomía
    A.3.2Name or abbreviated title of the trial where available
    LACO15
    LACO15
    A.4.1Sponsor's protocol code numberLACO15
    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 SponsorJavier E. Morales Sarabia
    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 supportConsorcio Hospital General Universitario de Valencia
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConsorcio Hospital General Universitario de Valencia
    B.5.2Functional name of contact pointServicio de Anestesia y Reanimación
    B.5.3 Address:
    B.5.3.1Street AddressAvenida tres cruces nº2
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46014
    B.5.3.4CountrySpain
    B.5.4Telephone number0034963187554
    B.5.6E-mailartd_hguv@gva.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name VIMPAT 10 mg/ml solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    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.3.1Product nameLACOSAMIDE
    D.3.4Pharmaceutical form Solution for infusion in administration system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLACOSAMIDE
    D.3.9.1CAS number 175481-36-4
    D.3.9.2Current sponsor codeSPM 927
    D.3.9.4EV Substance CodeSUB25407
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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 placeboSolution for infusion in administration system
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute postoperative pain
    Dolor agudo postoperatorio
    E.1.1.1Medical condition in easily understood language
    postoperative pain
    door tras intervención quirúrgica
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effectiveness in pain relief at 6 hours after administration of a single dose of 100 mg of intravenous lacosamide given in the immediate preoperative chest surgery with thoracotomy approach compared with placebo.
    Evaluar la eficacia en el alivio del dolor a las 6 horas tras administración de dosis única de 100 mg de lacosamida endovenosa administrada en el preoperatorio inmediato de cirugía de tórax con abordaje por toracotomía comparada con placebo.
    E.2.2Secondary objectives of the trial
    - Evaluate the effectiveness in pain relief within 48 hours after four doses of 100 mg lacosamide intravenous (100 mg every 12 hours) compared to placebo.
    - Incidence of neuropathic pain at 48 hours after four doses of 100 mg lacosamide intravenous.
    - Side effects associated with lacosamide during the first 48 hours.
    - Postoperative opioid consumption in control group compared to placebo group.
    - Evaluate the intensity of nociceptive and neuropathic pain after discharge the patient in the first review
    - Evaluar la eficacia en el alivio del dolor a las 48 horas tras administración de cuatro dosis de lacosamida 100 mg i.v. cada 12 horas.
    - Incidencia de dolor neuropático a las 48 horas.
    - Efectos secundarios asociados a lacosamida durante las primeras 48 horas.
    - Consumo de opioides postoperatorios in el grupo control respecto a placebo.
    - Evaluar la intensidad de dolor nociceptivo y neuropático en la primera revisión al alta del paciente tras la intervención quirúrgica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients over 18 years and less than or equal to 75 years.
    - Patients undergoing thoracic surgery for non-small cell lung cancer (NSCLC) with curative intent or resection of lung metastases by thoracotomy.
    - Patients ASA I-III.
    - Signature of informed consent.
    - Pacientes mayores de 18 años y menores o igual a 75 años.
    - Pacientes sometidos a cirugía torácica por cáncer de pulmón no microcítico (CPNM) con intención curativa o resección de metástasis pulmonares mediante toracotomía.
    - Pacientes ASA I-III.
    - Firma del consentimiento informado.
    E.4Principal exclusion criteria
    - Patient refusal.
    - Other diseases that warrant its non-inclusion according to medical criteria: severe renal disease (stage 3 and 4), liver disease (stages B and C ChildPugh) or psychiatric, heart rhythm disorders, bleeding disorders, pregnancy and lactation.
    - Lacosamide allergy, NSAIDs, local anesthetics and / or morphic.
    - Alcoholism.
    - Drug addiction.
    - Concurrent use of opioid analgesics or anti-epileptic type in the immediate preoperative period.
    - History of epilepsy or any neurological condition that needs treatment with lacosamide or other antiepileptic drug.
    - Functional status ASA> III.
    - Inability to understand the pain assessment scales.
    - Surgery that does not involve thoracotomy (pure thoracoscopic surgery or VATS).
    previous thoracotomy.
    - Pathology affecting the chest wall (locally invasive lung cancer, empyema thoracis necessitans, intercostal neural lesions, pathological fractures rib).
    - Surgery involving extensive involvement of the parietal pleura (such as pleurodesis, pleurectomy, extrapleural resection of the tumor).
    - Closing technique with metallic suture points.
    - Rechazo del paciente.
    - Otras enfermedades que aconsejen su no inclusión según criterio médico: patología severa renal (estadio 3 y 4), patología hepática (ChildPugh estadios B y C) o psiquiátrica, trastornos del ritmo cardiaco, trastornos de la coagulación, el embarazo y la lactancia.
    Alergia a Lacosamida, AINES, anestésicos locales y/o a mórficos.
    - Alcoholismo.
    - Adicción a drogas.
    - Uso concurrente de analgésicos de tipo opioides o antiepilépticos en el periodo preoperatorio inmediato.
    - Antecedentes de epilepsia o cualquier condición neurológica que precise de tratamiento con lacosamida u otro fármaco antiepiléptico.
    - Estado funcional ASA > III.
    - Incapacidad para entender las escalas de valoración del dolor.
    - Cirugía que no implique toracotomía (cirugía toracoscópica pura o cirugía videoasistida).
    - Toracotomía previa.
    - Patología que afecte a la pared torácica (cáncer de pulmón localmente invasivo, empiema thoracis necessitans, lesiones neuronales intercostales, fracturas patológicas costales).
    - Cirugía que implique afectación extensa de la pleura parietal (tal como pleurodesis, pleurectomía, resección del tumor extrapleural).
    E.5 End points
    E.5.1Primary end point(s)
    The drug is considered effective when the difference between the average value of the VAS (visual analog scale) at 6 hours of lacosamide treated group and the mean value of the VAS at 6 hours of control group, is at least 50%.
    Se considera que el fármaco ha sido eficaz cuando la diferencia entre el valor medio de la EVA (escala visual analógica) a las 6 horas del grupo tratado con lacosamida y el valor medio de la EVA a las 6 horas del grupo control, sea al menos del 50%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 hours after lacosamide administration (+/- 30 minutes).
    6 horas tras la administración de lacosamida.
    E.5.2Secondary end point(s)
    - The drug is considered effective when the difference between the average value of the VAS at 48 hours of lacosamide treated group and the mean value of the VAS at 48 hours of control group, is at least 50%.
    - Incidence of onset of neuropathic pain in both groups measured by rating scale Pain Detect and DN4.
    - Consumption of intravenous morphine administered by PCA (patient controlled analgesia pump) in both groups.
    - Incidence of adverse effects associated with lacosamide.
    - insensitive of neurotic (measured by Pain Detect and DN4 scales) and nociceptive pain (measured by VAS scale) in both groups in the first postoperative visit after discharge.
    - Se considera que el fármaco ha sido eficaz cuando la diferencia entre el valor medio de la EVA a las 48 horas del grupo tratado con lacosamida y el valor medio de la EVA a las 48 horas del grupo control, sea al menos del 50%.
    - Incidencia de aparición de dolor neuropático en los dos grupos medida mediante escala de valoración Pain Detect y DN4.
    - Consumo de morfina intravenosa administrada mediante bomba de PCA en ambos grupos.
    Incidencia de efectos adversos asociados a lacosamida.
    Intensidad de dolor neuropatico (medido por escalas Pain detect y DN4) y nociceptivo (medido por escala EVA) en ambos grupos en la primera visita postoperatoria
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 48h after first dose of lacosamide. (+/- 120 minutes).
    - 48 h. (+/- 120 minutes).
    - 48 h. (+/- 120 minutes).
    - 48 h.(+/- 120 minutes).
    - 15 days. (+/- one week).
    - 48h tras primera dosis de lacosamida (+/- 120 minutos)
    - 48 h.
    - 48 h.
    - 48 h.
    - 15 días. (+/- una semana).
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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 (is the last visit of the last subject enter).
    El final del estudio es la última visita del último paciente incluído.
    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 months
    E.8.9.1In the Member State concerned days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state66
    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)
    None
    Ninguno
    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 Decision2017-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-07
    P. End of Trial
    P.End of Trial StatusOngoing
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