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    Summary
    EudraCT Number:2010-020109-34
    Sponsor's Protocol Code Number:EMR 701165-024
    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:2010-12-27
    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 number2010-020109-34
    A.3Full title of the trial
    A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberEMR 701165-024
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMERCK SERONO SA
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameSAFINAMIDE
    D.3.2Product code NW-1015
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 codeNW-1015
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Cognition in non-demented patients with idiopathic Parkinson’s disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to explore whether safinamide, administered orally at a dose of 100 mg daily for 12 weeks under double-blinded conditions as add-on therapy to a stable dopaminergic therapy, is superior to placebo in improving cognition in non-demented (ND) subjects with idiopathic PD and subjective complaints of cognitive dysfunctions.
    E.2.2Secondary objectives of the trial
    1. Explore whether safinamide, administered orally at a dose of 100 mg daily as add-on therapy to stable dopaminergic therapy further improves cognition during a 12-week open-label phase. 2. Explore the influence of safinamide on two cognitive phenotypes (i.e., fronto-striatal executive deficits and posterior cortically based deficits). 3. Gather data on the potential of safinamide to improve mood, sleep, and behavior (including apathy). 4. Further assess the safety and tolerability of safinamide in PD subjects.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    FARMACOGENETICA: Versione:1.0 Data:2010/06/15 Titolo:SOTTOSTUDIO FARMACOGENETICO ANALISI GENETICA ESPLORATIVA Obiettivi:
    E.3Principal inclusion criteria
    Inclusion Criteria 1. Male/female outpatients (45- 80 years inclusive) 2. Idiopathic Parkinson’s disease (PD) (UK PDS Brain Bank Criteria) and Hoehn and Yahr Staging I-III at Screening. Diagnosis will be based on medical history and neurological examination 3. Subjects and informants must report cognitive impairment in at least one cognitive domain on the PDCognitive Questionnaire 4. Cognitive impairment must be confirmed by a total score ≤ 26 on the Montreal Cognitive Assessment 5. Subjects must be able to speak, read, and write in the language in which the tests are written and must be able to perform all assessments in this language 6. Subjects treated with dopaminergic therapy at a stable dose for at least four weeks prior to Screening and for the duration of the study 7. Subjects must understand and sign the appropriate approved Informed Consent Form(s), one for the study (mandatory), one for the pharmacogenetic evaluation (optional)
    E.4Principal exclusion criteria
    Exclusion Criteria 1. Any indication of forms of Parkinsonism other than idiopathic PD 2. Parkinson’s disease Dementia 3. Dementia with Lewy Bodies 4. Any clinically significant DSM-IV-TR Axis I Disorders, current diagnosis of substance abuse, history of alcohol/drug abuse for three months prior to Screening 5. Mental/physical/social condition which could preclude performing efficacy or safety assessments 6. Severe white matter disease, multiple lacunar infarcts, signs of significant vascular changes on Magnetic Resonance Imaging 7. Signs/symptoms suggestive of transmissible spongiform encephalopathy or family members who suffer(ed) from such 8. Current history of severe dizziness/fainting on standing 9. Any cardiovascular disease or condition 10. Subjects with human immunodeficiency virus infection, positive results on hepatitis B/C antibody tests or on tests for hepatitis B surface antigen (unless vaccinated) 11. Neoplastic disease currently active/in remission for less than one year 12. Clinically significant/unstable medical conditions 13. End-of-dose wearing-off, on-off phenomena, disabling peak dose- or biphasic dyskinesia, unpredictable/ widely swinging fluctuations 14. Current or past participation in another trial within 30 days prior to Screening or treatment with any investigational product within 30 days or five half-lives, whichever was longer, prior to Screening 15. Clinically significant hypertension, contraindications/hypersensitivity to monoamine oxidase-Type B inhibitors 16. Anticholinergic medication and/or amantadine within four weeks prior to Screening 17. Opioids or MAO inhibitors within eight weeks prior to Screening (dextromethorphan allowed for cough). One tricyclic- or tetracyclic antidepressant or trazodone permitted if at low dose as sleeping aid 18. Acetylcholinesterase inhibitors/memantine within four weeks before initiation of study treatment or during the study 19. Depot neuroleptic drugs during the study or within one injection cycle, oral neuroleptics within four weeks prior to Screening (stable dose of quetiapine < 100 mg/day for eight weeks prior to Screening allowed) 20. Drugs with hepatotoxic potential within four weeks prior to Screening, radiation therapy, drugs with cytotoxic potential within one year prior to Screening 21. Subjects likely to be non-compliant/uncooperative 22. Women who are pregnant, lactating, attempting to conceive 23. Women of childbearing potential not willing to use adequate contraceptive method (unless surgically sterilized) for four weeks prior to, during, and four weeks after last dose of trial medication 24. Significant ophthalmologic abnormality 25. Limited/absent legal capacity
    E.5 End points
    E.5.1Primary end point(s)
    Total score reduction in the Parkinson’s Disease Cognitive Rating Scale (PD-CRS) at 12 weeks compared to total score on the PD-CRS at 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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.8.3 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 EEA9
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    La fine dello studio conicide con la data dell`ultima visita dell`ultimo soggetto.
    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 months6
    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 months6
    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.1.3Elderly (>=65 years) Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 100
    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)
    AL PAZIENTE SARa` ASSICURATA LA CONTINUAZIONE DI UN TRATTAMENTO STANDARD SECONDO PRATICA CLINICA E A SECONDO DELLE NECESSITa` DEL SINGOLO PAZIENTE. AI PAZIENTI SARa` DATA LA POSSIBILITa` DI ESSERE ARRUOLATI IN UNO STUDIO IN APERTO A LUNGO TERMINE.
    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 Decision2010-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-05
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