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    Summary
    EudraCT Number:2010-023963-16
    Sponsor's Protocol Code Number:1014802/202
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-16
    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 number2010-023963-16
    A.3Full title of the trial
    A Placebo-Controlled, Double-Blind Randomized
    Withdrawal Study to Evaluate the Safety and Efficacy of
    CNV1014802 in Patients with Trigeminal Neuragia
    Studio di fase IIa controllato verso placebo, randomizzato in doppio cieco, di sospensione, finalizzato a valutare l’efficacia e la sicurezza di CNV1014802 in pazienti affetti da nevralgia del trigemino
    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
    Uno studio clinico per valutare l'efficacia di un farmaco denominato CNV1014802 per il dolore intenso al viso e per valutarne la sicurezza
    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 01223 755501
    B.5.5Fax number+44 01223 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.3.9.2Current sponsor codeCNV1014802
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product 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.3.9.2Current sponsor codeCNV1014802
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Nevralgia del trigemino
    E.1.1.1Medical condition in easily understood language
    Intense face pain
    Dolore intenso al viso
    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 10029227
    E.1.2Term Neuralgia trigeminal
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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.
    Indagare l’effetto della somministrazione orale ripetuta di CNV1014802 sul dolore avvertito nella nevralgia del trigemino.
    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
    Indagare la sicurezza e la tollerabilità di CNV1014802 in pazienti affetti da nevralgia del trigemino.
     Valutare le concentrazioni e le esposizioni plasmatiche di CNV1014802.
     Valutare l’impiego del questionario “Brief Pain Inventory”– del viso come misura di valutazione per la qualità della vita nella nevralgia del trigemino.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible for inclusion in this study only if all of the
    following criteria apply:
    1. IHS criteria for trigeminal neuralgia to be used. The diagnosis must be
    verified by a member of the diagnostic sub-committee of the DMC 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
    2. 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.
    3. Male or female between 18 and 70 years of age inclusive, at the time
    of signing the informed consent.
    4. 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 in Section 7.5 if they wish to continue their HRT during the
    study.
    • Child-bearing potential and agrees to use one of the contraception
    methods listed in Section 0 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.
    5. Male patients must agree to use one of the contraception methods
    listed in Section 7.5. This criterion must be followed from the time of the
    first dose of study medication until 14 days post-last dose.
    6. Body weight ≥ 50 kg for men and ≥ 45 kg for women.
    7. BMI ≤34.9.
    8. 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.
    9. Three ECGs taken at least 5 min apart should be performed at
    Screening. QTcB either/or QTcF < 450 msec in at least two of the three
    ECGs .
    10. AST and ALT < 2xULN; alkaline phosphatase and bilirubin ≤ 1.5xULN
    (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and
    direct bilirubin <35%).
    11. Approved concomitant medications must have been stable for at
    least 3 weeks prior to day 0
    Un/a paziente è idoneo/a all’inclusione in questo studio solo se soddisfa tutti i criteri elencati di seguito.
    1. Per la diagnosi di nevralgia del trigemino utilizzare i criteri IHS. Un membro del sottocomitato diagnostico del DMC deve confermare la diagnosi prima di poter arruolare il/la paziente nello studio.
    Diagnosi di nevralgia del trigemino: il dolore è unilaterale e lancinante, simile a una scossa elettrica, di breve durata, insorge e scompare improvvisamente ed è limitato a uno o più segmenti del nervo trigemino. Il dolore è scatenato spesso da stimoli banali come lavarsi, radersi, fumare, parlare e/o lavarsi i denti (fattori scatenanti) e di frequente insorge spontaneamente. Gli attacchi vanno e vengono rapidamente. Spesso tra un attacco e l’altro il/la paziente non avverte dolore e nell’arco di una giornata possono verificarsi più attacchi. Gli attacchi sono sovente seguiti da un periodo refrattario: per alcuni minuti dopo il dolore acuto taluni pazienti possono avvertire del dolore residuo.
    I pazienti possono attraversare periodi di remissione di settimane o mesi in cui non avvertono dolore, anche qualora abbiano sospeso la terapia.
    Per la diagnosi di nevralgia del trigemino occorre soddisfare i criteri diagnostici elencati di seguito.
    • Attacchi parossistici che possono durare dalla frazione di un secondo a 2 minuti, interessano uno o più segmenti del nervo trigemino e soddisfano i criteri b e c
    • Il dolore presenta almeno una delle seguenti caratteristiche:
    i. intenso, acuto, superficiale o lancinante
    ii. provocato dalla stimolazione di aree specifiche o da fattori scatenanti
    • Attacchi stereotipati nel/la singolo/a paziente
    • Assenza di deficit neurologici clinicamente evidenti
    • Dolore non attribuibile ad altro disturbo
    2. Criteri di frequenza per il numero dei parossismi:
    • i pazienti devono aver sofferto di almeno 3 o più parossismi di dolore al giorno, con un’intensità pari o superiore a 4 alla scala NRS, per almeno 4 degli ultimi 7 giorni precedenti l’ingresso nel periodo di trattamento in aperto
    3. Soggetti di entrambi i sessi, di età compresa tra 18 e 70 anni inclusi al momento della firma del consenso informato
    4. I soggetti di sesso femminile sono idonei a partecipare se soddisfano le seguenti condizioni:
    • non sono in età fertile, ovvero sono in pre-menopausa con legatura delle tube o isterectomia documentata; o sono in post-menopausa, definita come amenorrea spontanea da 12 mesi [per confermare eventuali casi dubbi eseguire un esame del sangue per verificare che i livelli di ormone follicolo-stimolante (FSH) siano ≥= 25,8 MlU/ml e quelli di estradiolo &lt; 40 pg/ml (&lt;140 pmol/L)]. Se in terapia ormonale sostitutiva (TOS) e in menopausa non confermata, dovranno utilizzare uno dei metodi contraccettivi specificati nella Sezione 7.5 per poter continuare la TOS durante lo studio;
    • se in età fertile, dovranno accettare di utilizzare uno dei metodi contraccettivi elencati nella Sezione 0 per un periodo di tempo appropriato (in base alle indicazioni del prodotto o dello sperimentatore) prima di iniziare la terapia per prevenire in misura sufficiente il rischio di gravidanza.
    I soggetti di sesso femminile devono acconsentire a utilizzare un metodo contraccettivo fino a 3 giorni dopo l’ultima dose di farmaco in studio
    5. I soggetti di sesso maschile devono acconsentire a utilizzare uno dei metodi contraccettivi elencati nella Sezione 7.5 Questo criterio deve essere rispettato a partire dalla prima somministrazione del farmaco in studio fino a 14 giorni dopo l’ultima dose
    6. Peso corporeo ≥= 50 kg per gli uomini e ≥= 45 kg per le donne
    7. IMC ≤= 34,9
    8. Capacità di firmare il modulo di consenso informato, che comprende il rispetto dei requisiti e delle restrizioni specificati nel modulo di consenso. Il consenso informato deve essere ottenuto prima di dare avvio a qualsiasi procedura...CONTINUA
    E.4Principal exclusion criteria
    • Patients who are known non-responders to sodium channel blockers at
    therapeutic doses.
    • 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 Cantibody 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, gastrointestinal, 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 or lactating females.
    • History or presence of any clinically significant
    abnormality in vital signs / ECG / laboratory tests or have any medical
    or psychiatric condition, which, in the opinion of the Investigator may
    interfere with the study
    procedures or compromise patient safety.
    • History of suicidal ideation and/or suicide attempts or clinical evidence
    of recent major depression.
    • Patients who are unable to maintain approved
    medications for their trigeminal neuralgia at a stable dose during the
    study.
    • Unable to refrain from excessive use of sedatives.
    • Unable to comply with the prohibited concomitant medication
    restrictions as detailed in the protocol. This includes but is not limited to
    sodium channel blockers or drugs that adversely interact with a
    monoamine oxidase-
    B inhibitor: MAOI's, antidepressants, opioids and sympathomimetic
    agents.
    • History of hypersensitivity to CNV1014802.
    • The patient has participated in a clinical trial and has received an
    investigational product within 5 half-lives or twice the duration of the
    biological effect of the investigational product (whichever is longer)
    prior to the start of this study.
    • Exposure to more than four new chemical entities (medications for
    which no marketing authorization has been obtained) 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.
    • Pazienti con assenza di risposta accertata ai bloccanti dei canali del sodio a dosi terapeutiche;
    • Pazienti con dolore facciale che ha cause diverse da quelle specificate nei Criteri di inclusione;
    • Positività a un test tossicologico effettuato nel periodo precedente lo studio.
    • Positività all’HIV;
    • Positività all’antigene di superficie dell’epatite B o all’anticorpo anti-epatite C nei 3 mesi precedenti lo screening;
    • Malattia epatica negli ultimi 6 mesi, a eccezione dei casi confermati di sindrome di Gilbert;
    • Abuso regolare di alcool nei 6 mesi precedenti lo studio;
    • Pazienti con una storia o a rischio di convulsioni o con una storia di epilessia, trauma cranico o disturbi neurologici correlati;
    • Pazienti con una storia di ipertensione non controllata o scarsamente controllata, con PAS spesso superiore a 160mmHg e/o PAD spesso superiore a 100mmHg, o pazienti con PAS pari o superiore a 160mmHg e/o PAD pari o superiore a 100mmHg allo screening dopo misurazioni ripetute;
    • Storia o presenza di significativa malattia cardiovascolare, gastrointestinale o renale o di altra patologia che notoriamente interferisce con l’assorbimento, la distribuzione, il metabolismo o l’escrezione dei farmaci;
    • Pazienti con disturbi della conduzione cardiaca o con storia personale o familiare di sindrome di Brugada;
    • Pazienti in gravidanza o allattamento;
    • Storia o presenza di anomalie clinicamente significative nei segni vitali / nel tracciato ECG / nei risultati degli esami di laboratorio o presenza di patologia medica o psichiatrica che, nell’opinione dello Sperimentatore, possa interferire con le procedure di studio o compromettere la sicurezza del/la paziente;
    • Storia di ideazione suicidaria e/o di tentativi di suicidio o evidenze cliniche di una recente depressione maggiore;
    • Pazienti non in grado di assumere i farmaci approvati per la nevralgia del trigemino a dosi stabili per l’intera durata dello studio;
    • Incapacità di astenersi dall’uso eccessivo di sedativi;
    • Incapacità di rispettare le restrizioni sui farmaci proibiti durante lo studio, come specificato nel protocollo, ivi compresi, a titolo puramente esemplificativo, i bloccanti dei canali del sodio o i farmaci che interferiscono negativamente con l’azione di un inibitore delle monoaminossidasi B: IMAO, antidepressivi, oppioidi e agenti simpaticomimetici;
    • Storia di ipersensibilità a CNV1014802;
    • Partecipazione a uno studio clinico e assunzione di un prodotto sperimentale entro 5 emivite o per un periodo superiore a due volte la durata dell’effetto biologico del prodotto sperimentale (a seconda di quale dei due periodi sia più lungo) prima dell’inizio dello studio;
    • Esposizione a più di 4 nuove sostanze chimiche (farmaci ancora privi di autorizzazione all’immissione in commercio) nei 12 mesi precedenti il primo giorno di somministrazione del farmaco in studio;
    • Casi in cui la partecipazione allo studio comporterebbe una donazione complessiva di sangue o di prodotti ematici superiore a 500 mL in un periodo di 56 giorni;
    • Incapacità legale o mentale del/la paziente;
    • Incapacità o indisponibilità a rispettare le procedure descritte nel protocollo.
    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:
    • 50% increase in the frequency of paroxysms compared to the final 7
    days of the open-label
    period• 50% increase in the severity of pain experienced in the paroxysms
    compared to the final 7 days of the open-label period
    • A Patient Global Improvement of Change rating of much worse/very
    much worse
    • The patient discontinues the study due to 'Lack of Efficacy'
    • The patient discontinues due to an adverse reaction or poor tolerability
    considered to be
    related to study medication
    I pazienti saranno classificati come non-responder se soddisfano uno dei criteri elencati di seguito.
    • Aumento del 50% nella frequenza dei parossismi rispetto agli ultimi 7 giorni del periodo in aperto
    • Aumento del 50% nell’intensità del dolore avvertito durante i parossismi rispetto agli ultimi 7 giorni del periodo in aperto
    • Punteggio PGIC (Patient Global Impression of Change) pari a “molto peggio/decisamente peggio”
    • Ritiro del/la paziente per “mancanza di efficacia”
    • Ritiro del/la paziente a causa di una reazione avversa o di scarsa tollerabilità considerata correlata al farmaco in studio
    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 clinician global impression of
    change rating will be determined on Day 21 and Day 49.
    Il/la paziente registrerà quotidianamente la frequenza e la gravità dei parossismi. I punteggi PGIC (Patient Global Impression of Change) e CGIC (Clinician Global Impression of Change) saranno determinati ai Giorni 21 e 49.
    E.5.2Secondary end point(s)
    Efficacy Endpoints:
    • Number and severity of paroxysms of pain in the 21 day open-label
    period both evoked and spontaneous.
    • 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 Telephone Interview of Cognitive Status –
    Modified and Medical Outcome Study - Cognitive Scale
    • Adverse event profile (AEP) scale
    Endpoint di efficacia:
    • numero e gravità dei parossismi di dolore, sia spontanei che provocati, nel periodo di 21 giorni in aperto
    • punteggio medio nelle 24 ore alla scala PI-NRS (Pain Intensity Numerical Rating Scale)
    • punteggi PGIC e CGIC
    • punteggio BPI–Facial (Brief Pain Inventory – Facial)

    Farmacocinetica:
    • concentrazioni plasmatiche di CNV1014802 pre- e post-dose – AUC-ss, Cmin-ss e Cmax-ss

    Sicurezza:
    • eventi avversi
    • segni vitali
    • parametri ECG
    • analisi di sicurezza di laboratorio (parametri ematochimici, ematologici, esame delle urine)

    Endpoint esplorativi:
    • valutazione della relazione tra il profilo farmacocinetico (PK) e farmacodinamico (PD), se possibile in base ai dati
    • valutazione della funzione cognitiva mediante le scale TICS (Telephone Interview for Cognitive Status) e mMOS-Cog (Modified Medical Outcome Study - Cognitive Scale)
    • scala di valutazione del profilo degli eventi avversi (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 clinician 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 in screening and on Day 0, 7, 14, 21, 28,
    35, 42, 49 and 56.Lab 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 event profile scale will be determined in screening
    and on Day 21 and 49. Adverse events will be collected throughout.
    Il/la paziente registrerà quotidianamente la frequenza e la gravità dei parossismi. I punteggi PGIC (Patient Global Impression of Change) e CGIC (Clinician Global Impression of Change) saranno determinati ai Giorni 21 e 49. Il punteggio BPI-Facial sarà determinato nei Giorni 0, 21, 49 e 56.
    I parametri farmacocinetici saranno valutati ai Giorni 0, 7, 21, 35 e 49. La misurazione dei segni vitali e gli ECG saranno effettuati allo screening e ai Giorni 0, 7, 14, 21, 28, 35, 42, 49 e 56. I campioni per le analisi di sicurezza di laboratorio saranno prelevati allo screening e ai Giorni 0, 7, 21, 35, 49 e 56. Lo stato cognitivo sarà valutato ai Giorni 0, 21 e 49. Il profilo degli eventi avversi sarà determinato allo screening e ai Giorni 21 e 49. Gli eventi avversi saranno raccolti..
    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 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 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 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
    Disegno randomizzato di sospensione
    Randomised withdrawal design
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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.1.1Number of subjects for this age range: 0
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    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 drugs or may opt for surgical management after completion of the study because this drug is not approved for treatment of trigeminal neuralgia.
    Al termine dello studio il/la paziente riprenderà la sua precedente terapia farmacologica o potrà optare per un intervento chirurgico poiché questo farmaco non è approvato per il trattamento della nevralgia del trigemino.
    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 Decision2012-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-26
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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