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    Summary
    EudraCT Number:2011-004378-27
    Sponsor's Protocol Code Number:CAFQ056A2299
    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:2012-03-02
    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 number2011-004378-27
    A.3Full title of the trial
    An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson's patients with L-dopa induced dyskinesias
    Studio in aperto per valutare la sicurezza, la tollerabilita' e l'™efficacia di AFQ056 in pazienti affetti da malattia di Parkinson con discinesie indotte da L-dopa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
    Studio di estensione, in aperto, a lungo termine, di sicurezza, tollerabilita' e efficacia in pazienti affetti da malattia di Parkinson con discinesie indotte da L-dopa
    A.4.1Sponsor's protocol code numberCAFQ056A2299
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01491932
    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 SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    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 supportNovartis
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 96541
    B.5.5Fax number+39 02 9659066
    B.5.6E-mailinfo.studiclinici@novartis.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 nameNA
    D.3.2Product code AFQ056
    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 INNmavoglurant
    D.3.9.1CAS number 543906-09-8
    D.3.9.2Current sponsor codeAFQ056
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 nameNA
    D.3.2Product code AFQ056
    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 INNmavoglurant
    D.3.9.1CAS number 543906-09-8
    D.3.9.2Current sponsor codeAFQ056
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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 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: 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 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 nameNA
    D.3.2Product code AFQ056
    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 INNmavoglurant
    D.3.9.1CAS number 543906-09-8
    D.3.9.2Current sponsor codeAFQ056
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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 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: 4
    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 nameNA
    D.3.2Product code AFQ056
    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 INNmavoglurant
    D.3.9.1CAS number 543906-09-8
    D.3.9.2Current sponsor codeAFQ056
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    L-dopa induced dyskinesias in patients with Parkinson's disease
    Pazienti affetti da malattia di Parkinson con discinesie indotte da L-dopa
    E.1.1.1Medical condition in easily understood language
    Parkinson's Patients With L-dopa Induced Dyskinesias
    Pazienti con Parkinson con discinesie indotte da L-dopa
    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 HLT
    E.1.2Classification code 10013929
    E.1.2Term Dyskinesias and movement disorders NEC
    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 evaluate the long-term safety and tolerability of AFQ056 in patients with PD-LID as assessed by •Incidence and severity of adverse events and serious adverse events •Changes in vital signs, laboratory assessments, and ECGs •Changes in underlying symptoms of PD as measured by the UPDRS (Unified Parkinson's Disease Rating Scale) part III (Motor Examination) and AEs potentially related to an exacerbation of the movement disorder of PD
    Valutare la sicurezza e la tollerabilità a lungo termine di AFQ056 in pazienti con PD-LID definite tramite: • Incidenza e severità degli eventi avversi e degli eventi avversi seri • Variazioni nei segni vitali, nelle valutazioni di laboratorio e negli elettrocardiogrammi • Variazioni nei sintomi sottostanti della malattia di Parkinson, misurati tramite o Scala UPDRS (Unified Parkinson’s Disease Rating Scale) parte III (Esame motorio) o Eventi avversi potenzialmente correlati ad una esacerbazione del disordine di movimento della malattia di Parkinson
    E.2.2Secondary objectives of the trial
    To evaluate the anti-dyskinetic efficacy of AFQ056 treatment in patients with PD-LID on dyskinesia as assessed by •mAIMS (modified Abnormal Involuntary Movement Scale) total score •the Revised Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) patient and caregiver versions •items 32, 33 and 34 of Part IV of the UPDRS
    Valutare l’efficacia anti-discinetica del trattamento con AFQ056 in pazienti con discinesie indotte da Ldopa definita tramite : • Punteggio totale della scala mAIMS (modified Abnormal Involuntary Movement Scale) • Scala Revised Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) versione del paziente e del caregiver • Item 32, 33 e 34 della UPDRS Parte IV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients who have completed a previous AFQ056A study or are eligible as defined in the core study protocol - Outpatients - Patients who have a primary caregiver willing and able to assess the condition of the patient throughout the study in accordance with protocol requirements Other protocol-defined inclusion criteria may apply
    pazienti eleggibili per l’inclusione in questo studio devono soddisfare tutti i seguenti criteri: • Pazienti che hanno completato lo studio principale o che sono eleggibili secondo quanto definito nel protocollo dello studio principale • Maschi e femmine • Pazienti ambulatoriali • Consenso informato firmato prima che venga effettuata qualsiasi valutazione e prima che venga assunto il farmaco in studio
    E.4Principal exclusion criteria
    -Atypical or secondary form of Parkinson's disease -History of surgical treatment for PD including deep brain stimulation -Advanced, severe, or unstable disease (other than PD) -History of malignancy -Evidence of dementia -Untreated/ineffectively treated mental disorders -Treatment with certain prohibited medications -Abnormal lab values or heart abnormalities -Pregnant or nursing women Other protocol-defined exclusion criteria may apply
    I pazienti che soddisfano uno qualsiasi dei seguenti criteri al momento della prima visita (Visita di Screening per i pazienti del Gruppo 2 e Visita Basale per i pazienti del Gruppo 1, rispettivamente, a meno che non venga specificata un’altra visita) non saranno eleggibili per l’inclusione nel presente studio. • Malattia di Parkinson di forma atipica o secondaria • Storia di trattamento chirurgico per la PD, compresa la stimolazione cerebrale profonda • Punteggio 5 nella fase ON nella scala Modified Hoehn and Yahr Staging • Qualsiasi patologia (diversa dalla PD) avanzata, severa o instabile • Evidenza di demenza (o MMSE ≤ 26) • Disordine depressivo maggiore non trattato o trattato in modo non efficace; pazienti che attualmente manifestano allucinazioni/psicosi che richiedono trattamento anti-psicotico, e/o stati confusionali (DSM-IVR, Diagnostic and Statistical Manual of Mental Disorders, 4° edizione, revisionata) • Trattamento con uno qualsiasi dei seguenti: o forti o moderati inibitori di CYP3A4 entro 1 settimana prima della visita basale o forti o moderati induttori di CYP3A4 entro 1 settimana prima della visita basale o warfarina o digossina entro 1 settimana prima della visita basale o amantadina entro 3 giorni prima della visita basale o metoclopramide entro 3 giorni prima della visita basale o agenti neurolettici tipici entro 1 settimana prima della visita basale Per maggiori dettagli consultare i paragrafi 4.1 e 4.2 del protocollo originale.
    E.5 End points
    E.5.1Primary end point(s)
    a)Incidence rate of adverse events including serious adverse events b)Severity of adverse events including serious adverse events c)Change in vital signs d)Changes in hematology/blood chemistry and urinalysis laboratory evaluations e)Change in ECGs f)Change in Unified Parkinson's Disease Rating Scale (UPDRS) part III scores g)Incidence of AEs to an exacerbation of the underlying movement disorder Parkinson's disease
    a)Tasso di incidenza di eventi avversi compreso gli eventi avversi seri b)Severità degli eventi avversi compresi gli eventi avversi seri c)Cambiamenti nei segni vitali d)Cambiamenti nelle valutazioni di laboratorio (ematologia, biochimica, analisi delle urine...) e)Cambiamenti nell'ECGs f)Cambiamenti nella''Unified Parkinson's Disease Rating Scale (UPDRS) part III scores'' g)Tasso d'incidenza degli AEs riferiti ad una escerbazione dei disordini dei movimenti nella malattia di Parkinson
    E.5.1.1Timepoint(s) of evaluation of this end point
    a) and b)Monitored for the duration of the study (anticipated to be an average of 3 years) c)Assessed at Day -14 to -3, Day 1, Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation. d) and e)Assessed at Day -14 to -3, Day 1,Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter. If a patient discontinues in between these visits, these will be assessed at the time of discontinuation. f)Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation. g)Monitored for the duration of the study (anticipated to be an average of 3 years)
    a) e b)Controllato per tutta la durata dello studio (circa 3 anni) c)Valutato dal Giorno -14 al -3, G 1, Settimane 1, 2, 4, 8, 12, Mesi 6, 9, 12, ogni 6 mesi quindi. Se un paziente discontinuasse fra queste visite, la valutazione è prevista al momento della discontinuazione. d)ed e)valutazione dal Giorno -14 al -3, Giorno 1,Settimane 4, 8, 12, Mesi 6, 9,12, ogni 6 mesi quindi. Se un paziente discontinuasse fra queste visite, la valutazione è prevista al momento della discontinuazione. f)Valutazione al Giorno 1, Settimane 4, 8, 12, Mesi 6, 9, 12, ogni 6 mesi quindi. Se un paziente discontinuasse fra queste visite, la valutazione é prevista al momento della discontinuazione. g)Controllato per tutta la durata dello studio (previsto per circa 3 anni)
    E.5.2Secondary end point(s)
    a)Change in mAIMS (modified Abnormal Involuntary Movement Scale) total score b)Change in Revised Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) scores (patient and caregiver versions) c)Change in score for items 32, 33, and 34 of Part IV of the UPDRS d)Change in Mini Mental State Exam (MMSE) score e)Change in the Scales for outcomes in Parkinson's disease – Psychiatric Complications (SCOPA-PC) score f)Proportion of patients who have suicidal ideation and behavior as mapped to Columbia Classification Algorithm for Suicide assessment (CCASA) using data from Columbia-Suicide Severity Rating Scale (C-SSRS)
    a)Cambiamenti nella mAIMS (modified Abnormal Involuntary Movement Scale) total score b)Cambiamenti nella Revised Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) scores (versione paziente e caregiver) c)Cambiamenti nella ''score per items 32, 33, e 34 della Part IV della UPDRS d)Cambiamenti nel''Mini Mental State Exam (MMSE) score e)Cambiamenti nelle ''Scales for outcomes in Parkinson's disease – Psychiatric Complications (SCOPA-PC) score'' f)Percentuale di pazienti che hanno ideazione e comportamento suicidi come tracciato nella ''CCASA'' utilizando dati dalla ''Columbia-Suicide Severity Rating Scale (C-SSRS)''
    E.5.2.1Timepoint(s) of evaluation of this end point
    a)Assessed at Day 1, Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter. b)Assessed at Day 1, Weeks 4, 12, Months 6, 9, 12, every 6 months thereafter. c) and e)Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter. d)Assessed at Day -14 to -3, Day 1 (only if not done in the respective core study), Months 6, 12, every 6 months thereafter. a), b), c), d) and e) If a patient discontinues in between these visits, this will be assessed at the time of discontinuation. f)monitored for the duration of the study (anticipated to be an average of 3 years)
    a)Valutazione al Giorno 1, Settimane 1, 2, 4, 8, 12, Mesi 6, 9, 12, ogni 6 quindi. b)Valutazione al Giorno 1, Settimane 4, 12, Mesi 6, 9, 12, ogni 6 mesi quindi. c) ed e)Valutazione al Giorno 1, Settimane 4, 8, 12, Mesi 6, 9, 12, ogni 6 mesi quindi. d)Valutazione dal Giorno -14 al -3, Giorno 1 (soltanto se non già valutato negli studi core), Mesi 6, 12, quindi ogni 6 mesi. a), b), c), d) ed e) Se un paziente discontinuasse fra queste visite, queste valutazione verrano eseguite al momento della discontinuazione. f)controllato per tutta la durata dello studio(previsto per circa 3 anni)
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    tollerabilità
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Canada
    United States
    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 : 17.NOV.2015
    LVLS : 17.11.2015
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months44
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months45
    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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 65
    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)
    Expecting the study to run until the drug become available on the market. The study will be complete when all patients receiving study drug have completed their final visit (Visit 199). The investigator must provide follow-up medical care for all patients who are prematurely withdrawn from the study, or must refer them for appropriate ongoing care
    Lo studio dovrebbe coprire i pazienti fino alla disponibilità del farmaco sul mercato. Lo studio sarà completo quando tutti i pazienti che ricevono il farmaco in esperimentazione avranno completato la loro visita finale (visita 199). Lo esperimentatore deve fornire l'assistenza medica necessaria a tutti i pazienti che si ritirano anticipatamente dallo studio, o deve indirizzarli ad una terapia appropiata.
    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 Decision2012-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-09-02
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