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    Summary
    EudraCT Number:2016-001575-71
    Sponsor's Protocol Code Number:B7601011
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-001575-71
    A.3Full title of the trial
    A 15 WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON’S DISEASE
    EINE 15-WÖCHIGE, DOPPELBLINDE, RANDOMISIERTE, PLACEBOKONTROLLIERTE PHASE-II-STUDIE MIT FLEXIBLER DOSIS ZUR UNTERSUCHUNG DER WIRKSAMKEIT, SICHERHEIT UND VERTRÄGLICHKEIT VON PF-06649751 BEI PATIENTEN MIT PARKINSON IM FRÜHSTADIUM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASE
    EINE 15-WÖCHIGE, STUDIE MIT FLEXIBLER DOSIS ZUR UNTERSUCHUNG DER WIRKSAMKEIT, SICHERHEIT UND VERTRÄGLICHKEIT VON PF-06649751 BEI PATIENTEN MIT PARKINSON IM FRÜHSTADIUM
    A.4.1Sponsor's protocol code numberB7601011
    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 SponsorPfizer, Inc.
    B.1.3.4CountryUnited States
    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 supportPfizer, Inc
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number1800 718 1021
    B.5.5Fax number1303 739 1119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 namePF-06649751
    D.3.2Product code PF-06649751
    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 INNPF-06649751
    D.3.9.2Current sponsor codePF-06649751
    D.3.9.3Other descriptive namePF-06649751
    D.3.9.4EV Substance CodeSUB178413
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 namePF-06649751
    D.3.2Product code PF-06649751
    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 INNPF-06649751
    D.3.9.2Current sponsor codePF-06649751
    D.3.9.3Other descriptive namePF-06649751
    D.3.9.4EV Substance CodeSUB178413
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 namePF-06649751
    D.3.2Product code PF-06649751
    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 INNPF-06649751
    D.3.9.2Current sponsor codePF-06649751
    D.3.9.3Other descriptive namePF-06649751
    D.3.9.4EV Substance CodeSUB178413
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboTablet
    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
    Parkinson's Disease
    E.1.1.1Medical condition in easily understood language
    Gradually developing disorder of the nervous system that affects movement.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    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 effect of PF 06649751 administered once daily on motor symptoms in subjects with early stage Parkinson’s disease.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of PF 06649751 administered once daily in subjects with early stage Parkinson’s disease.
    - To evaluate the effect of PF 06649751 administered once daily on other domains relevant in early Parkinson’s disease (eg, depression, daytime sleepiness, and cognition).
    - To characterize steady state plasma concentrations of PF 06649751.
    - To explore the relationship between PF 06649751 plasma exposures and relevant study endpoints.
    - Pooled or exploratory analyses, if conducted, utilizing the biobanked exploratory genomic and biomarker samples across PF 06649751 studies or across multiple programs will be documented in a separate protocol and/or statistical analysis plan.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
    2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Females of non childbearing potential and/or male subjects between the ages of 45 and 80 years, inclusive.
    4. Male subjects able to father children must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment.
    5. Female subjects of non childbearing potential (ie, meet at least 1 of the following criteria):
    - Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    - Have medically confirmed ovarian failure; or
    - Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the post menopausal state.
    6. Clinical diagnosis of Parkinson’s disease consistent with the United Kingdom (UK) Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria (Appendix 4).
    7. Parkinson’s Disease Hoehn & Yahr Stage I III inclusive.
    8. Parkinson’s disease subjects deemed appropriate for treatment of motor symptoms with a MDS UPDRS Part III score >=10.
    9. Treatment naïve or history of prior incidental treatment with dopaminergic agents (including L Dopa and dopamine receptor agonist medications) for no more than 28 days and not within at least 7 days prior to Visit 1 (Randomization) as outlined in Section 5.8, Concomitant Treatment(s), and Appendix 2 in the protocol.
    10. Willing and able to refrain from any Parkinson’s disease medication not permitted by the protocol (including dopaminergic agents) throughout participation in the study as outlined in Appendix 2 in the protocol.
    11. A score of >=26 on the Mini Mental State Examination (MMSE).
    12. Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight >= 45 kg.

    E.4Principal exclusion criteria
    1. History or clinical features consistent with an atypical Parkinsonian syndrome (including but not limited to Progressive Supranuclear Palsy, Multiple System Atrophy, Cortico Basal Degeneration, etc).
    2. Any Parkinson’s disease related feature or symptom that could interfere with the study conduct and results as assessed by the sponsor or Investigator.
    3. Presence of acute or chronic clinically significant medical, including fever, or psychiatric condition or cognitive impairment or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    4. Presence or history of brain tumor, past history of hospitalization for head trauma with loss of consciousness, epilepsy (as defined by the International League Against Epilepsy)E31, including childhood seizures, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), or known increased risk of seizures.
    5. Any significant AXIS I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition Revised (DSM IV TR, American Psychiatric Association, 2000) including subjects with clinically significant depression (PHQ 8 total score >=15) (refer to Section 7.1.6 of the protocol, Depression Assessment (PHQ 8). Presence of minor depression or treated, stable depressive disorder is acceptable.
    6. Subjects who have made a suicide attempt within the last 5 years. Subjects who, in the investigator’s judgment, pose a significant suicide risk. Subjects who have suicidal ideation associated with actual intent and a method or plan in the past 6 months (ie, “Yes” answers on items 4 or 5 of the C-SSRS; refer to Section 7.3 Assessment of Suicidal Ideation and Behavior (C-SSRS).
    7. History of clinically significant alcohol or substance dependency (other than caffeine or nicotine), as defined in DSM IV TR, within 1 year before Screening.
    8. In the opinion of the investigator (or caregiver, as applicable), has signs/symptoms suggestive of clinically significant cognitive impairment that would interfere with the ability to comply with study procedures.
    9. Any condition possibly affecting drug absorption, past surgery of the gastrointestinal tract (eg, gastrectomy, colectomy), except cholecystectomy.
    10. History of vasculitis.
    11. History of Human Immunodeficiency Virus (HIV) infection.
    12. History of malignancy other than:
    • Non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in situ that was surgically removed in total >1 year before screening and has not recurred.
    • Other type of malignancy which has been in remission 5 years or more before screening and has not recurred.
    13. Subjects with first degree family history of unexplained sudden death, or of Long QT syndrome (LQTS).
    14. Within 1 year of Screening or between Screening and Visit 1 (Randomization), any of the following: myocardial infarction; moderate or severe congestive heart failure, NYHA class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
    15. Currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration) as outlined in Section 5.8 Concomitant Treatment(s), Appendix 2, and Appendix 3.
    16. Currently receiving an antipsychotic, metoclopramide, reserpine, or amphetamine as outlined in Section 5.8 Concomitant Treatment(s) and Appendix 2.
    17. Prohibited concomitant medications as outlined in Section 5.8, Concomitant Treatment(s), and Appendix 2.
    18. Pregnant female subjects; breastfeeding female subjects; females of childbearing potential (assessed at Screening); male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product or longer based upon the compound’s half life characteristics.
    19. Screening supine blood pressure >=160 mm Hg (systolic) or >=95 mm Hg (diastolic), on a single measurement. If abnormal, up to 2 repeats are permitted following at least 5 minutes of rest. The screening value in that case will be the average of the 2 values closest to the normal range.

    Please refer to the study protocol for full list of exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    (Efficacy) Change from baseline in the Modified Unified Parkinson’s Disease Rating Scale (MDS UPDRS) Score Part III
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 15
    E.5.2Secondary end point(s)
    (Safety and Tolerability)
    - Adverse events.
    - Clinical laboratory parameters.
    - Vital signs.
    - Electrocardiogram (ECG) parameters.
    - Columbia Suicide Severity Rating Scale (C-SSRS).
    - Questionnaire for Impulsive Compulsive Disorders in Parkinson’s Disease – Rating Scale (QUIP RS).
    - Physician Withdrawal Checklist (PWC 20).

    (Exploratory endpoints)
    - Beck Depression Inventory – II (BDI II).
    - Epworth Sleepiness Scale (ESS).
    - Patient Global Impression Severity (PGI S).
    - Patient Global Impression – Improvement (PGI I).
    - Parkinson’s Disease Questionnaire (PDQ 39).
    - EuroQol 5 Dimension (EQ 5D 5L).
    - Oral Symbol Digit Modality Test.
    - Modified Clinical Global Impression-Severity (MCGI S).
    - Modified Clinical Global Impression-Improvement (MCGI I).
    - MDS – UPDRS Part I.
    - MDS – UPDRS Part II.
    - MDS – UPDRS Parts II + III.
    - MDS – UPDRS Parts I + II + III.
    - MDS – UPDRS Total Score (Parts I + II + III + IV).
    - Average plasma PF-06649751 concentrations
    - Exploratory exposure response relationship with relevant endpoints.
    - Serum Prolactin level at Visit 14.
    - Banked biospecimens for possible follow up analysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and tolerability endpoints are assessed throughout the course of the study

    Exploratory endpoints:
    - Change from baseline at Weeks 10 and 15: BDI II, ESS, PGI S, PGI I, PDQ 39, EQ 5D 5L, Symbol Digit Modality Test, MCGI S, MCGI I, MDS - UPDRS Part I and Part II, Parts II+III, Parts I+II+III, Total Score - Parts I+II+III+IV
    - PF-06649751 plasma concentrations - Visit 4, 6, 10, 12 and 14
    - Serum prolaction level
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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.8.2.4Number 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    France
    Germany
    Israel
    Spain
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.1.1In 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: 53
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 88
    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.
    Keine
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation FCRIN NS-Park Network
    G.4.3.4Network Country France
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Studienzentrale Kompetenznetz Parkinson, Klinik für Neurologie
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation DupCheck Statistics, Ltd
    G.4.3.4Network Country Israel
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-29
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