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    Summary
    EudraCT Number:2014-004902-13
    Sponsor's Protocol Code Number:D0490C00023
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-31
    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 ConcernedFinland - Fimea
    A.2EudraCT number2014-004902-13
    A.3Full title of the trial
    A 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects with Multiple System Atrophy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the effect of AZD3241 in Multiple System Atrophy
    A.4.1Sponsor's protocol code numberD0490C00023
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Desk
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus Astraallen
    B.5.3.2Town/ citySodertalje
    B.5.3.3Post codeSE-151 85
    B.5.3.4CountrySweden
    B.5.6E-mailInformation.center@astrazeneca.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1404
    D.3 Description of the IMP
    D.3.1Product nameAZD3241 100mg
    D.3.2Product code AZD3241
    D.3.4Pharmaceutical form Prolonged-release 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 INNNot available
    D.3.9.1CAS number 890655-80-8
    D.3.9.2Current sponsor codeAZD3241
    D.3.9.3Other descriptive nameIUPAC name: 1-(2-Isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one
    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.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1404
    D.3 Description of the IMP
    D.3.1Product nameAZD3241 300mg
    D.3.2Product code AZD3241
    D.3.4Pharmaceutical form Prolonged-release 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 INNNot available
    D.3.9.1CAS number 890655-80-8
    D.3.9.2Current sponsor codeAZD3241
    D.3.9.3Other descriptive name1-(2-Isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    D.8 Placebo: 2
    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
    Multiple system atrophy (MSA)
    E.1.1.1Medical condition in easily understood language
    A rare, sporadic, progressive, adult-onset neurodegenerative
    disorder of the central and autonomic nervous systems.
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10064060
    E.1.2Term Multiple system atrophy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the safety and tolerability of AZD3241.
    • To determine the effect of AZD3241 on microglia activation, as measured by [11C]PBR28 binding.
    E.2.2Secondary objectives of the trial
    • To determine the biomarker effects of AZD3241
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    2 Optional Sub-studies-
    1) PGt (Pharmacogenetic) analysis - a whole genome or exome analysis or targeted analyses of DNA polymorphisms may be conducted e.g., MPO, α-synuclein, and coenzyme Q2 genotype determination by sequencing.
    Objective: Determination of the association between DNA and protein variation and the response to treatment with AZD3241.
    2) CSF Sampling –
    Objective: To determine the potential effect(s) of AZD3241 on surrogate marker(s) of MPO activity e.g., oxidized apolipoprotein A-1.
    E.3Principal inclusion criteria
    1. Males or females, aged 30-80 years.
    2. Meet criteria for diagnosis of probable or possible MSA according to the consensus criteria (Gilman et al. 2008).
    3. “High-affinity binder” or “mixed-affinity binder” for TSPO, confirmed by prospective genotyping of TSPO polymorphism.
    4. Female subjects of childbearing potential must:
    a. Have a negative serum β-hCG pregnancy test result at screen and a negative urine β-hCG test result at baseline, and
    b. Agree not to become pregnant during participation in the study, and
    c. Agree, if sexually active, to routinely use two methods of contraception during the study, for 40 days after the last dose of AZD3241, and for 3 months after the last administration of [11C]PBR28. One method must be a medically approved contraceptive. The other method must be condom use. Hormonal contraceptives sensitive to CYP3A4 induction are not permitted as a method of
    contraception.
    5. Postmenopausal females must have follicle-stimulating hormone (FSH) ≥ 38 mIU/mL at screen.
    6. Males must agree to refrain from donating sperm during the study, for 100 days following the last dose of AZD3241, and for 3 months after the last administration of [11C]PBR28. Sexually active male subjects must:
    a. Agree to use condoms during the study, for 100 days after the last dose of AZD3241, and for 3 months after the last administration of [11C]PBR28.
    b. Agree to ensure that they and their partners are routinely using a
    medically approved contraceptive method.
    7. Medical treatment of MSA and co-morbid medical conditions must be
    stable for at least 30 days prior to screen and between screen and
    baseline (Day -1). Intermittently administered treatment may be
    considered stable if the dose and dosing frequency have been unchanged
    for the greater of 30 days or three dosing intervals (e.g., a treatment
    given once a month must be at a stable dose and dosing frequency for 3
    months).
    8. Able to swallow tablets whole.
    E.4Principal exclusion criteria
    -Prior participation in any AZD3241 studies
    -MRI performed during screen not consistent with MSA diagnosis
    -ET scan or other procedure with administration of a radiopharmaceutical in the last 12 months
    -Negative Allen test in both hands unless brachial artery used for
    arterial cannulation
    - Subjects determined as low affinity binders by TSPO genotyping
    - Claustrophobia contraindicating brain MRI or PET scans
    -Pregnancy, lactation or positive serum β-hCG at screen or positive
    urine β-hCG at baseline
    - Initiation or change in pharmacologic therapy for MSA symptoms
    within 30 days prior to screen or between screen and baseline
    - Other significant neurological disease affecting CNS , that may affect
    motor or autonomic function or ability to complete the study including
    Alzheimer's, idiopathic Parkinson's, other Parkinson plus syndromes or
    secondary parkinsonism
    - History of brain surgery for parkinsonism
    - History of stem cell treatment
    - Seizure disorder unless well controlled, for which treatment has been stable for at least 30 days prior to screen and between screen and
    baseline
    - Presence of any clinically significant medical condition that is clinically
    unstable, is likely to deteriorate during the study, could put the patient
    at risk because of participation, affect ability to complete the study or
    influence study results
    - History or presence of thyroid disease
    - An abnormal TSH or FT4 test result at screen or baseline
    - History or presence of GI or other disease or history of surgery known
    to interfere with absorption, distribution, metabolism, or excretion of drugs
    - Evidence of acute suicidal ideationHistory of suicidal behavior
    - History of alcohol, drug abuse, dependence (except nicotine
    dependence) within 1 year prior to screen
    - Urine drug screen positive for a drug of abuse.
    - Myocardial infarction; hospitalization for congestive heart failure or
    symptoms of unstable angina; syncope not related to MSA within 1 year
    prior to screen or between screen and baseline
    - Moderate or severe congestive heart failure or known ejection fraction
    < 40%
    - History or presence of renal disease or impaired renal function
    - Estimated creatinine clearance < 60 mL/min according to the
    Cockcroft-Gault equation at screen
    - A QT interval corrected by the Fridericia procedure (QTcF) > 450 msec at screen (single ECG measurement) or baseline (Day -1) (mean of three
    ECG measurements), or a family history of long-QT syndrome
    - Uncontrolled hypertension, 2 or more systolic readings > 220 mmHg or
    diastolic readings > 105 mmHg
    - History or presence of diabetes unless glucose levels have been well
    controlled and treatment has been stable for at least 30 days prior to
    screen and between screen and baseline
    - HbA1c ≥ 6.5% at screen
    - Clinically significant infection within 30 days prior to screen or
    between screen and baseline
    - History of cancer within the last 5 years except nonmetastatic basal
    cell skin carcinoma
    - Any clinically important abnormality on physical examination or vital
    signs, ECG, or clinical laboratory test other than abnormality due to a
    stable, well-controlled medical condition or any abnormality that could be detrimental to the subject or compromise the study
    - Aspartate aminotransferase, alanine aminotransferase, or alkaline
    phosphatase > 2 x upper limit of normal at screen or baseline
    - Positive serologic findings for HIV, HBsAg or HCV antibodies
    - History of 2 or more clinically important drug allergies
    - Clinically significant blood clotting or bleeding disorder
    - Use of antipsychotic medication within 3 months prior to screen or
    between screen and baseline
    - Use of any anticoagulant or oral glucocorticoid within 30 days prior to
    baseline PET scan
    - Use of metoclopramide, thyroid medication or regular use of narcotic
    pain medication within 30 days prior to baseline
    - Use of potent inhibitors of CYP3A4 or CYP1A2 within 14 days prior to
    baseline
    - Use of potent inducers of CYP3A4 or CYP1A2 or drugs mainly
    metabolized by CYP3A4 or CYP2B6 that are sensitive to potential
    induction by AZD3241 within 30 days prior to baseline
    - Treatment with any investigational drug or device within 60 days or 5
    half-lives prior to screen, whichever is longer, or between screen and
    baseline
    - Plasma donation within 1 month prior to screen or between screen and
    baseline
    - Blood donation/blood loss > 500 mL within 3 months prior to screen
    - AstraZeneca employee or 1st degree relative, participating clinical trial
    site employee
    - Presence of MRI contraindications
    PGt testing sub-study:
    - Previous allogenic bone marrow transplant
    - Non-leukocyte-depleted whole blood transfusion within 4 months prior
    to testing CSF sampling sub-study:
    - Any spinal malformations or other aspects (eg tattoos) or other clinical
    findings (eg papilledema) that may complicate or contraindicate lumbar puncture
    - Neoplasm or other space-occupying intracranial lesion on MRI
    E.5 End points
    E.5.1Primary end point(s)
    1) [11C]PBR28 binding to translocator protein as measured by PET
    2) Incidence of adverse events (AEs) and serious adverse events (SAEs) including frequency and severity
    3) Change from baseline in vital signs (supine and standing blood pressure and pulse), oral temperature, weight, clinical laboratory tests, and ECG
    4) Physical Exam
    5) Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C SSRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Screening and after 12 weeks of study medication
    2) Screening, baseline, after 1, 2, 3, 4, 8, and 12 weeks of study medication and 14 ± 7 days after the last dose of study medication
    3) Screening, baseline, after 1, 2, 3, 4, 8, and 12 weeks of study medication and 14 ± 7 days after the last dose of study medication
    4) Screening and after 12 weeks of study medication
    5) Screening, baseline, after 1, 2, 3, 4, 8, and 12 weeks of study medication and 14 ± 7 days after the last dose of study medication
    E.5.2Secondary end point(s)
    Biomarker analysis - MPO activity
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Baseline and after 12 weeks of study medication
    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 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.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Austria
    Finland
    France
    Italy
    Sweden
    United Kingdom
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months21
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months21
    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: 41
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 64
    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
    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 Decision2015-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-29
    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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