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    Summary
    EudraCT Number:2018-000405-23
    Sponsor's Protocol Code Number:Versio_1
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-21
    Trial 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 ConcernedFinland - Fimea
    A.2EudraCT number2018-000405-23
    A.3Full title of the trial
    In vivo PET imaging of neuroinflammation in Parkinson’s disease using the purinergic P2X7 receptor ligand [11C]SMW139 (PRI-PD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Postitron emission tomography imaging of neuroinflammation in Parkinson´s disease
    A.3.2Name or abbreviated title of the trial where available
    PRI-PD
    A.4.1Sponsor's protocol code numberVersio_1
    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 SponsorJuha Rinne / PET Centre
    B.1.3.4CountryFinland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing 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 name(2-chloro-5-[11C]methoxy-N-(((3s,5s,7s)-3,5,7-trifluoroadamantan-1-yl)methyl) benzamide)
    D.3.2Product code [11C]SMW139
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Parkinson´s disease
    E.1.1.1Medical condition in easily understood language
    Parkinson´s disease
    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 LLT
    E.1.2Classification code 10034007
    E.1.2Term Parkinson's disease NOS
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: To determine regional binding differences of [11C]SMW139 in 7 PD patients and 7 healthy volunteers.
    E.2.2Secondary objectives of the trial
    Secondary objectives: Brain kinetics and determination of brain P2X7R availability (VT and BPND) using [11C]SMW139 PET in 7 PD patients and 7 healthy age-matched healthy controls. Correlation between nigro-striatal P2X7R availability measured with using [11C]SMW139 PET and DAT availability measured using [18F]FE-PE2I PET in 7 PD patients and 7 healthy age-matched healthy controls.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    HEALTHY VOLUNTEERS
    1. Subject is between 45 and 80 years (male/female).
    2. Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs.
    3. Subject’s body mass index is >18 and <30 kg/m2 with max weight of 100 kg
    4. Women should be of non-childbearing potential (contraception, postmenopausal, surgically sterile).
    5. No clinical evidence of a movement disorder as evidenced by careful neurological examination by a neurologist or a MD instructed by a movement disorder specialist.
    PARKINSON´S DISEASE PATIENTS:
    1. Subject is between 45 and 80 years (male/female).
    2. Subject has a clinical diagnosis of Idiopathic Parkinson’s Disease (IPD) according to UK PD brain bank criteria, with at least 2 of the cardinal signs of the disease: resting tremor, bradykinesia or rigidity.
    3. Subject has a modified Hoehn and Yahr stage ≤ 3.
    4. Female patients should be of non-childbearing potential (contraception, postmenopausal, surgically sterile).

    6. No evidence of cognitive impairment.
    7. Unremarkable MRI scan as assessed by expert radiologist, nuclear medicine physician or neurologist. In subjects < 60 years of age, no clinically significant abnormalities are allowed, in subjects >= 60 years of age white matter hyperintensities corresponding to a WML (white matter lesion) score <= 2 (of 3) on the ARWMC scale are acceptable.
    E.4Principal exclusion criteria
    HEALTHY VOLUNTEERS
    1. Subject has a history of any major disease that may interfere with the investigations (especially liver and kidney disease, or uncontrolled diabetes).
    2. Subject has any history of a major neurological disorder.
    3. Subject has elevated likelihood for hereditary Parkinson’s disease as assessed by family history.
    4. Subject has a history or evidence of psychiatric disease, especially depression. A Beck Depression Inventory score should be <= 9.
    5. Subject has had surgery, significant blood loss (> 500 ml), donated blood or participated in another clinical trial using investigational drug(s) within 30 days prior to the imaging day.
    6. Subject is currently a user (including ‘’recreational use’’) of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse.
    7. Subject chronically uses anti-inflammatory medication (steroids, non-steroidal anti-inflammatory drugs (NSAID), aspirine, paracetamol, etc.), or other medication known to interact with P2X7 receptors.
    8. Uncontrolled hypertension juged by the investigator. .
    9. Previous repetitive use of psychotropic medication.
    10. Pregnancy or lactation (only for women).
    11. Administration of any investigational product within 3 months before the start of the present study.
    12. Known or suspected drug, alcohol or other abuse, or positive urine drug screen which may interfere with the study objective as judged by the investigator.
    13. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator.
    14. Subject has a contra-indication for MRI scanning.
    15. Subject suffers from claustrophobia or cannot tolerate confinement during PET or MR scanning procedures; subject cannot lie still for 90 minutes inside the PET system.
    16. Subject does not understand the study procedure.
    17. Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator.
    18. Subject has a known allergy to xylocaine (which is be used as a local anesthetic for the placement of the arterial catheter).

    PARKINSON`S DISEASE PATIENTS
    1. Subject has parkinsonism not caused by idiopathic Parkinson’s disease (e.g. drug-induced, metabolic disorders, encephalitis, vascular parkinsonism, atypical parkinsonian syndromes such as multiple system atrophy, progressive supranuclear palsy and corticobasal degeneration).
    2. Subject has a history of another major neurological disorder or history of significant brain lesion (e.g. tumor, stroke).
    3. Subject has significant structural brain lesions on T1 or T2 MRI, unrelated to IPD.
    4. Subject has a history of any major disease that may interfere with radiotracer investigations (especially severe liver and kidney disease, or uncontrolled diabetes).
    5. Subject is unable to lie sufficiently still in the PET system, or has tremor with significant head movements.
    6. Subject consumes excessive alcohol (average > 4 units/day) or has recreational/illicit drug use (including cannabis).
    7. Subject chronically uses anti-inflammatory medication including systemic steroids.
    8. Subject has known allergy to lidocaine (which may be used as a local anesthetic for the placement of the arterial catheter).
    9. Uncontrolled hypertension judged by the investigator. .
    10. Previous repetitive use of psychotropic medication.
    11. Pregnancy or lactation (only for women).
    12. Administration of any investigational product within 3 months before the start of the present study.
    13. Known or suspected drug, alcohol or other abuse, or positive urine drug screen which may interfere with the study objective as judged by the investigator.
    14. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator.
    15. Subject has a contra-indication for MRI scanning.
    16. Subject suffers from claustrophobia or cannot tolerate confinement during PET scanning procedures.
    17. Subject does not understand the study procedure.
    18. Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Completion of PET imaging of patients with Parkinson´s disease and healthy controls with [11C]SMW139
    E.5.1.1Timepoint(s) of evaluation of this end point
    The end point will be evaluated after all study procedures in all Parkinson´s disease patients and healthy controls have been completed.
    E.5.2Secondary end point(s)
    Completion of study procedures other than PET imaging of patients with Parkinson´s disease and healthy controls with [11C]SMW139
    E.5.2.1Timepoint(s) of evaluation of this end point
    The end point will be evaluated after all study procedures in all Parkinson´s disease patients and healthy controls have been completed.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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
    To gain knowledge on the pathophysiology of Parkinson´s disease.
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    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 months3
    E.8.9.1In the Member State concerned 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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients 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 state14
    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)
    The study involves no treatment or administration of IMPs that have pharmacological effects. The study participants will continue their regular medication and planned normal treatment and follow-up of their condition.
    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 Decision2018-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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