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    Summary
    EudraCT Number:2019-000942-36
    Sponsor's Protocol Code Number:IMI2-PainCare-BioPain-RCT1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-000942-36
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, cross-over, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processing observed by Peripheral Nerve Excitability Testing (NET)
    Studio randomizzato, in doppio cieco, controllato con placebo, cross-over, multicentrico, in soggetti sani volto ad indagare gli effetti di lacosamide, pregabalin e tapentadolo sui biomarcatori del dolore mediante test di eccitabilità nervosa perferica (NET).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi-center trial in healthy subjects to investigate the effects of analgesic drugs on pain processing observed by Peripheral Nerve Excitability Testing (NET)
    Studio multicentrico su soggetti sani volto ad indagare gli effetti di farmaci analgesici sul processamento del dolore mediante lo studio della eccitabilità dei nervi periferici.
    A.3.2Name or abbreviated title of the trial where available
    The effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processing
    Gli effetti di lacosamide, pregabalin e tapentadolo sui biomarcatori del dolore
    A.4.1Sponsor's protocol code numberIMI2-PainCare-BioPain-RCT1
    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 SponsorUMBERTO I - POLICLINICO DI ROMA
    B.1.3.4CountryItaly
    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 supportInnovative Medicines Initiative 2 (IMI2) Joint Undertaking under grant agreement
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportEli Lilly and Company LTD
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportEsteve Pharmaceuticals SA
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportGrünenthal GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportTeva Pharmaceutical Industries LTD
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSapienza Università di Roma
    B.5.2Functional name of contact pointDipartimento di Neuroscienze Umane
    B.5.3 Address:
    B.5.3.1Street AddressViale dell'Università 30
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00185
    B.5.3.4CountryItaly
    B.5.4Telephone number0649914758
    B.5.5Fax number0649914586
    B.5.6E-mailandrea.truini@uniroma1.it
    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 PALEXIA - 50 MG COMPRESSE RIVESTITE CON FILM 10 COMPRESSE IN BLISTER PVC/PVDC/AL
    D.2.1.1.2Name of the Marketing Authorisation holderGRUNENTHAL ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nametapentadolo
    D.3.2Product code [N02AX06]
    D.3.4Pharmaceutical form 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 INNTAPENTADOLO CLORIDRATO
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB32145
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.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 Yes
    D.2.1.1.1Trade name VIMPAT - 100 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) 14 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderUCB PHARMA S.A.
    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.3.2Product code [N/A]
    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 INNLACOSAMIDE
    D.3.9.1CAS number 175481-36-4
    D.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeSUB25407
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.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 Yes
    D.2.1.1.1Trade name LYRICA - 75 MG CAPSULA RIGIDA - USO ORALE 100 CAPSULE IN BLISTER IN UNITA' SEPARABILI PERFORATO (PVC/ALU)
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namepregabalin
    D.3.2Product code [N03AX16]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREGABALIN
    D.3.9.1CAS number 148553-50-8
    D.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeSUB10023MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy volunteers (intended indication: pain)
    Soggetti sani (indicazione attesa: dolore)
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers (intended indication: pain)
    Soggetti sani (indicazione attesa: dolore)
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033371
    E.1.2Term Pain
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To test if the Strength Duration Time Constant (SDTC) changes (at planned first post-dose timing) of large sensory fibers differs in the lacosamide period as compared to the placebo period.
    2. To test if the Strength Duration Time Constant (SDTC) changes (at planned first post-dose timing) of large motor fibers differs in the lacosamide period as compared to the placebo period.
    1. Testare se i cambiamenti nell’ SDTC nelle fibre sensoriali di grosso calibro (al primo tempo post dose) differisce tra il braccio di trattamento con lacosamide rispetto al placebo.
    2. Testare se i cambiamenti nell’ SDTC nelle fibre di grosso calibro motorie (al primo tempo post dose) differisce tra il braccio di trattamento con lacosamide rispetto al placebo.
    E.2.2Secondary objectives of the trial
    1. To test if the SDTC changes (at planned first post-dose timing) of large sensory fibers differs in the pregabalin and/or tapentadol periods as compared to the placebo period
    2. To test if the SDTC changes (at planned first post-dose timing) of large motor fibers in the pregabalin and/or tapentadol periods differs as compared to the placebo period.
    3. To test if the SDTC changes (at planned first post-dose timing) of small sensory fibers differs in the lacosamide period as compared to the placebo period.
    1. Testare se i cambiamenti nell’ SDTC nelle fibre sensoriali di grosso calibro (al primo tempo post dose) differisce tra il braccio di trattamento con pregabalin e/o tapentadolo rispetto al placebo.
    2. 2. Testare se i cambiamenti nell’ SDTC nelle fibre di grosso calibro motorie (al primo tempo post dose) differisce tra il braccio di trattamento con pregabalin e/o tapentadolo rispetto al placebo.
    3. Testare se i cambiamenti nell’ SDTC nelle fibre sensoriali di piccolo calibro (al primo tempo post dose) differisce tra il braccio di trattamento con lacosamide rispetto al placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Provision of signed and dated informed consent form
    -Stated willingness to comply with all study procedures and regimens and availability for the duration of the study.
    -Caucasian male or female subjects, aged 18 years to 45 years
    -Subjects must be in good health as determined by the medical history, physical and laboratory examinations and must not show any clinically significant deviations from reference ranges as determined by 12-lead electrocardiogram (ECG), vital signs (blood pressure, pulse rate and respiratory rate) and laboratory parameters (renal and hepatic function)
    -Body mass index >18 kg/m2 and < 30 kg/m2 with a minimum body weight of 45.0 kg and a maximum of 100kg (for men and women)
    -Ability to take oral medication
    -For female subjects of childbearing potential: use of highly effective contraception with a low failure rate defined as <1% per year for at least 1 month prior to screening and agreement to use such a methodduring study participation and for an additional 4 weeks after the end of study drug administration: -combined (estrogen and progestogen containing) hormonal contraception, -progestogen-only hormonal contraception associated with inhibition of ovulation, -an intra-uterine device (hormone-free), -an intra-uterine hormone releasing system (IUS). A woman of non-childbearing potential may be included if surgically sterile (i.e., after hysterectomy or bilateral oophorectomy) or post-menopausal for at least 2 years.
    -Right hand dominance (assessed using the Edinburgh Handedness Inventory, and defined as a score =60)
    -Presenza di modulo di consenso informato firmato e datato
    -Accertata volontà di rispettare tutte le procedure e i regimi di studio e la disponibilità per la durata dello studio
    - Soggetti di razza caucasica, di sesso maschile o femminile, di età compresa tra 18 anni e 45 anni

    - In buona salute generale, come evidenziato dall’anamnesi, dall’esame fisico e dagli esami di laboratorio in assenza di alcuna deviazione significativa dai range di riferimento come determinato da un elettrocardiogramma (ECG) a 12 derivazioni, segni vitali (pressione arteriosa, frequenza cardiaca e frequenza respiratoria) e parametri laboratoristici (funzione epatica e renale)

    - Indice di massa corporea> 18 kg / m2 e <30 kg / m2 con un peso corporeo minimo di 45,0 kg e un massimo di 100 kg (per uomini e donne)

    - Capacità di assumere farmaci per via orale

    - Per le donne con potenziale riproduttivo: uso di contraccezione altamente efficace (con un basso tasso di fallimento definito < 1% per anno) per almeno 1 mese prima dello screening e accordo sull'uso di tale metodo durante la partecipazione allo studio e per ulteriori 4 settimane dopo la fine della somministrazione del farmaco in studio:
    o Contraccezione ormonale combinata (estrogeno e progestinico)
    o Contraccezione ormonale progestinica associata ad inibizione dell’ovulazione
    o Dispositivo intrauterino (privo di ormoni)
    o Dispositivo di rilascio ormonale intrauterino (IUS)
    Una donna non potenzialmente fertile può essere inclusa se chirurgicamente sterile (dopo isterectomia o ovariectomia bilaterale) o in fase post menopausa da almeno 2 anni

    - Dominanza della mano destra (valutata utilizzando l'Inventario di Edimburgo Handedness e definito come un punteggio =60)
    E.4Principal exclusion criteria
    -Presence of any medical devices (e.g., cardiac pacemaker), implants or protheses unless it is beyond discussion that these will not put the subject's safety during the study at risk and will not interfere with the study results
    -Known or suspected allergic reactions / hypersensitivity to components of lacosamide/Vimpat®- pregabalin/Lyrica® and tapentadol / Palexia®.
    -II or III degree atrioventricular block.
    -Known contraindication for drugs with µ-opioid agonist activity, i.e., significant respiratory depression, acute or severe bronchial asthma orhypercapnia.
    -Present or suspected paralytic ileus.
    -Acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic drugs.
    -Not willing or able to abstain from changes in physical exercise activities during the Study.
    -Any chronic pain condition or recent (i.e. within the preceding 2 years) history thereof.
    -Migraine (at least 1 attack in the last 24 months).
    -Recurrent headache or back pain on more than 5 days/month in the last 3 months.
    -Caffeine consumption of more than 8 servings of coffee, tea, or other caffeinated drinks per day. Each serving is approximately 120mg of caffeine.
    -Any relevant symptom of neurological dysfunction of the motor and sensory system that may interfere with the conduct of the study.
    -Clinically-evident psychiatric diseases (e.g. depression, anxiety).
    -History or symptoms of central nervous system disease or peripheral nerve lesions or dysfunction with sequelae that may impact the study assessments or that may deteriorate by one dose of a drug with antiepileptic, noradrenergic or opioid activity.
    -Focused neurological examination showing signs of abnormality.
    -Active internal disease or sequelae of internal disease (e.g. diabetes mellitus, liver diseases, kidney diseases, cardiovascular diseases, hypoor hyperthyroidism, hypertension etc.).
    -Diseases or conditions known to interfere with the distribution, metabolism, or excretion of drugs.
    -Clinically significant disease or condition that may affect efficacy or safety assessments, or any other reasons, which, in investigator's opinion, may preclude the subject's participation in the trial.
    -Not willing or able to abstain from alcohol from 48 hours prior to any study period and until the end of the study period.
    -Consumption of cannabis in the last 4 weeks prior to the study.
    -Evidence or history of alcohol or drug (opioids, amphetamines, benzodiazepines, cannabinoids) abuse (as defined by ICD-10 or DSM IV) including positive or missing drugs of abuse screen (urine drugs ofabuse test).
    -Consumption of more than 21 alcohol units per week for male subjects and more than 14 units per week for female subjects (1alcohol unit = 1 beer [12 oz/355 mL] = 1 wine [5 oz/150 mL] = 1 liquor [1.5 oz/40 mL] = 0.75 oz/20 mL alcohol).
    -Habitually smoking more than 10 cigarettes, 2 cigars, or 2 pipes of tobacco per day within the last 6 months before enrollment in this trial.
    -Known or suspected of not being willing or able to comply with the requirements of the trial protocol or the instructions.
    -Inability to communicate meaningfully with the trial site staff (e.g. insufficient language skills).
    -Any person with direct involvement in the trial conduct; any person under the direct supervision of the investigator or dependent on the investigator.
    -Blood loss of 500 mL or more (e.g., owing to blood donation) within 3 months before enrollment in this trial.
    -Pregnancy, planned pregnancy or lactation.
    -Presence of dermatological conditions in the test areas of the study that would prevent the proper application of study procedures, such as electrodes for HFS, pinprick (dermatitis, psoriasis, contact eczema, etc.).
    -Any other reason to exclude the subject according to judgment by the investigator
    -Presenza di qualsiasi dispositivo medico (ad esempio, pacemaker cardiaco), impianto o protesi a meno che non sia definito non mettere a rischio la sicurezza del soggetto durante lo studio e non interferire con i risultati dello studio
    -Reazioni allergiche accertate o sospette / ipersensibilità ai componenti di lacosamide / Vimpat®, pregabalin/Lyrica®, tapentadol / Palexia®.
    -Blocco atrioventricolare di II o III grado.
    -Controindicazioni note per i farmaci con attività di agonisti degli oppioidi µ, cioè depressione respiratoria significativa, asma bronchiale acuta o grave o ipercapnia.
    -Ileo paralitico presente o sospetto.
    -Intossicazione acuta con alcol, ipnotici, analgesici ad azione centrale o psicofarmaci.
    -Non disposti o in grado di astenersi dai cambiamenti nelle attività di esercizio fisico durante lo studio.
    -Qualsiasi condizione di dolore cronico o recente (entro i precedenti 2 anni).
    -Emicrania (almeno 1 attacco negli ultimi 24 mesi).
    -Mal di testa o mal di schiena ricorrenti per più di 5 giorni / mese negli ultimi 3 mesi.
    -Consumo di caffeina con più di 8 porzioni di caffè, tè o altre bevande contenenti caffeina al giorno. Ogni dose è di circa 120 mg di caffeina.
    -Qualsiasi sintomo rilevante di disfunzione neurologica del sistema motorio e sensoriale che interferisca con lo studio.
    -Malattie psichiatriche clinicamente evidenti (ad es. Depressione, ansia).
    -Storia o sintomi di malattia del sistema nervoso centrale o lesioni o disfunzione dei nervi periferici con sequele che possono influire sulle valutazioni dello studio o che possono aggravarsi con una dose di un farmaco con attività antiepilettica, noradrenergica o oppioide.
    -Anormalità all’esame neurologico
    -Malattia internistica attiva o sequele di malattia internistica (ad esempio diabete mellito, malattie del fegato, renali, cardiovascolari, ipo- o ipertiroidismo, ipertensione ecc.).
    -Malattie o condizioni note per interferire con la distribuzione, il metabolismo o l'escrezione di farmaci.
    -Malattia clinicamente significativa o condizione che possa influire sull'efficacia o sulla valutazione della sicurezza, o per qualsiasi altra ragione che, a parere dello sperimentatore, può precludere la partecipazione del soggetto al trial.
    -Non disposto o in grado di astenersi dall'alcol da 48 ore prima di qualsiasi periodo di studio e fino alla fine del periodo di studio
    -Consumo di cannabis nelle ultime 4 settimane precedenti lo studio.
    -Prove o anamnesi di abuso di alcool o droghe (oppiacei, anfetamine, cannabinoidi, benzodiazepine) (come definito dall'ICD-10 o DSM IV) incluso lo screening positivo o assente per abuso di droghe (test dell'uso di droghe nelle urine). Consumo di più di 21 unità alcoliche a settimana per soggetti di sesso maschile e più di 14 unità a settimana per soggetti di sesso femminile (1 unità di alcol = 1 birra [12 oz / 355 ml] = 1 vino [5 oz / 150 ml] = 1 liquore [1,5 oz / 40 ml] = 0,75 oz / 20 ml di alcol).
    -Fumare abitualmente più di 10 sigarette, 2 sigari o 2 pipe di tabacco al giorno negli ultimi 6 mesi prima dell'arruolamento in questo studio.
    -Noto o sospetto di non essere disposti o in grado di soddisfare i requisiti del protocollo o le istruzioni.
    -Incapacità di comunicare con lo staff del sito di prova (ad esempio competenze linguistiche insufficienti).
    -Qualsiasi persona con coinvolgimento diretto nella condotta del trial; qualsiasi persona sotto la diretta supervisione dello sperimentatore o dipendente dallo sperimentatore.
    -Perdita di sangue di 500 ml o più (ad es. A causa di donazione di sangue) entro 3 mesi prima dell'arruolamento in questo studio.
    -Gravidanza, gravidanza programmata o allattamento.
    -Presenza di condizioni dermatologiche nelle aree testate nello studio che impedirebbero la corretta applicazione delle procedure di studio, come elettrodi per HFS, puntura di spillo (dermatite, psoriasi, eczema da contatto, ecc.).
    -Qualsiasi altro motivo per escludere il soggetto secondo il giudizio dell'investigatore
    E.5 End points
    E.5.1Primary end point(s)
    Changes of the Strength Duration Time Constant (SDTC) measured in large sensory fibers and in large motor fibers on the non-sensitized skin
    Cambiamenti nell’SDTC misurato nelle fibre di grosso calibro sensoriali e motorie nella cute non sensitizzata
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the planned first PD time point post dosing relative to their pre-dose PD measurement (i.e. difference to period specific baseline).
    Al primo time point pianificato post dose rispetto alla misurazione pre dose (differenza rispetto alla baseline)
    E.5.2Secondary end point(s)
    Strength Duration Time Constant (SDTC) measured in small sensory fibers
    Cambiamenti nell’SDTC misurato nelle fibre di piccolo calibro sensoriali
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the planned first PD time point post dosing relative to their pre-dose PD measurement (i.e. difference to period specific baseline).
    Al primo time point pianificato post dose rispetto alla misurazione pre dose (differenza rispetto alla baseline)
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    The trial is meant to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processing observed by noninvasive neurophysiological measurements of Peripheral nerve excitability.
    Il trial mira ad indagare gli effetti di lacosamide, pregabalin e tapentadolo sui biomarcatori del dolore testati mediante misure neurofisiologiche non invasive di eccitabilità nervosa periferica.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 trial4
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 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
    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 months7
    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 months7
    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: 60
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state12
    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)
    none
    nessuno
    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 Decision2020-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-05-25
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