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    Summary
    EudraCT Number:2009-013670-41
    Sponsor's Protocol Code Number:SYN118-CL03
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-07
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2009-013670-41
    A.3Full title of the trial
    A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson‟s Disease
    A.4.1Sponsor's protocol code numberSYN118-CL03
    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 SponsorSynosia Therapeutics AG
    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 Yes
    D.2.1.1.1Trade name Orfadin
    D.2.1.1.2Name of the Marketing Authorisation holderSWEDISH ORPHAN INTERNATIONAL AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Capsule*
    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.3.8INN - Proposed INNNITISINONE
    D.3.9.1CAS number 104206-65-7
    D.3.9.2Current sponsor codeSYN118
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboCapsule*
    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 inadequately controlled on a stable regimen of anti-Parkinsonian medications.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    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 safety, tolerability and efficacy of SYN118 when administered to subjects with PD who are inadequately controlled on a stable regimen of anti-Parkinson‟s medications.
    E.2.2Secondary objectives of the trial
    To improve control of PD symptoms for subjects inadequatelly treated with antiparkinsonian medication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects with a confirmed diagnosis of
    idiopathic Parkinson‟s disease (PD), meeting the UK
    Parkinson‟s Disease Society Brain Bank diagnostic criteria
    [Daniel et al., 1993], of a greater than 1 year duration, who
    are otherwise healthy and fulfill all of the inclusion criteria
    and none of the exclusion criteria.
    2. Age range 40 – 85 years.
    3. Modified Hoehn and Yahr Stage 2-4.
    4. Subjects in the “fluctuating” stage of PD with an average of at
    least 2 hours and no more than 6 hours “off” time during
    awake hours from the 24-hour patient diaries taken during the
    2 consecutive days directly preceding the scheduled
    Baseline/Day 1 visit.
    5. Subjects who have been levodopa-responsive for at least
    1 year and taking at least 4 doses per day (or at least 3 doses
    per day if 2 or more are a sustained-release formulation).
    Note: Combination products containing levodopa and
    levodopa/carbidopa with a COMT inhibitor in one fixed
    dosage form (Stalevo®) are permitted.
    6. If receiving allowed anti-Parkinson‟s medication(s) other than
    levodopa, subjects must have been clinically stable on the
    same dose for a minimum of 30 days before randomization.
    7. A Unified Parkinson‟s Disease Rating Scale (UPDRS) III
    Motor Examination score greater than 25 in defined “off”
    state at the screening and baseline assessment.
    8. Mini-mental state examination (MMSE) score greater than 24
    to rule out dementia.
    9. Good general health, free from significant co-morbid illnesses
    that could interfere with evaluation of study drug, as
    ascertained by detailed medical history and physical and
    laboratory examinations.
    10. Able to provide and have signed an Institutional Review
    Board/Independent Ethics Committee-approved written
    informed consent form to participate in this study.
    11. Plasma creatinine less than or equal to 2.2 mg/dL or
    194 μmol/L.
    12. Women with no childbearing potential; ie, woman who are
    surgically sterile or woman who have been post-menopausal
    for at least 1 year as confirmed by follicle-stimulating
    hormone (FSH) greater than or equal to 40 mIU/mL or
    40 IU/L.
    Men who have a sterile or post-menopausal sexual partner or
    have agreed to use contraception (eg, use of a condom with
    spermicide or use by partner of oral, implantable or injectable
    contraceptives, intrauterine device [IUD], diaphragm with
    spermicide), starting at the time of study drug administration
    and for a period of 1 month after the end of the study.
    13. Achieved the following results for PD diary training and
    baseline diary recordings:
    a. Completed the protocol-specified diary training during the
    screening period and achieved at least 75% diary
    concordance with the site trainer/rater.
    b. Returned diary recordings for the 2 consecutive days (ie, 2
    consecutive 24-hour periods) directly preceding the
    Baseline/Day 1 visit that have not more than 4 invalid
    entries per 24-hour period. An invalid diary entry is
    defined as more than 1 entry recorded in a given half-hour
    interval or the absence of an entry in a given half-hour
    interval.
    Note: Subjects who are otherwise eligible but do not meet the
    criteria for proper diary completion may be retrained and can
    return for another baseline assessment within the 3-week
    window of the screening period.
    14. Able to understand study requirements and able and willing to
    follow instructions, attend all required study visits, and
    undergo all planned tests.
    E.4Principal exclusion criteria
    1. Atypical or secondary parkinsonism.
    2. Prior neurosurgical operation for Parkinson‟s disease (PD).
    3. Subjects being treated concomitantly with both a COMT and a
    MAO-B inhibitor.
    4. Subjects taking or requiring adjunctive therapy for
    Parkinson‟s disease (PD) with apomorphine.
    5. Subjects treated with intraduodenal preparations of levodopa
    (eg, Duodopa) or with intradermal levodopa delivered with a
    pump.
    6. Subjects with a dyskinesia score of 3 or 4 on UPDRS subscale
    IV, Item 33 at the screening or baseline assessment; peak-dose
    dyskinesia will not exclude otherwise eligible subjects.
    7. Any 12-lead ECG with any of the following abnormalities at
    screening: 2nd or 3rd degree heart block, conduction
    disorders, ventricular and/or atrial arrhythmias; (1st degree
    bradycardia: non-specific ST and T wave changes are
    acceptable if reviewed, approved and documented as not
    clinically significant [NCS] by the Investigator).
    8. Subjects with active ocular disease (not including cataracts)
    including but not limited to: infection, inflammation, macular
    degeneration, optic nerve degeneration.
    9. History of conjunctivitis, corneal opacity, keratitis,
    photophobia, or blepharitis in the past 2 years.
    10. Subjects who have been diagnosed and/or require therapy to
    treat a psychiatric disorder other than depression including but
    not limited to Parkinson‟s dementia or drug induced
    hallucinations/paranoia, dementia, schizophrenia or bipolar
    disorder.
    11. Geriatric Depression Scale (short form) score greater than 8.
    12. Subjects receiving treatment for depression with antidepressants
    if they have not been on a stable dose for 30 days
    prior to randomization.
    13. Any other condition or clinically significant abnormal
    findings on the physical or neurological examination (eg,
    multiple system atrophy, recent stroke), medical and
    psychiatric history, or clinical laboratory results at screening
    that, in the opinion of the Investigator, make the subject
    unsuitable for the study or put the subject at additional risk.
    14. Potential exposure to SYN118 (Orfadin®, nitisinone) outside
    the context of the present trial.
    15. Subjects who require drugs that are inducers of the P450
    CYP3A4 isoenzyme including, HIV antivirals (efavirenz,
    nevirapine), barbiturates, carbamazepine, glucocorticoids,
    modafinil, phenobarbital, phenytoin, rifampin, St. John's
    wort, troglitazone, oxcarbazepine, pioglitazone, rifabutin.
    The following site may be referred to in determining whether
    drugs not listed can induce this enzyme:
    http://medicine.iupui.edu/clinpharm/ddis/table.asp
    16. Preparations containing iron and/or amino acids, for example
    some multi-vitamin/mineral preparations or nutritional
    supplements.
    17. Received treatment with any other investigational drug within
    5 half-lives or 30 days prior to signature of informed consent,
    whichever is longer, or any investigational device within 30
    days prior to signature of informed consent.
    18. Pregnant or lactating females.
    E.5 End points
    E.5.1Primary end point(s)
    This is an exploratory study, no primary endpoints defined.
    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 No
    E.6.12Pharmacoeconomic No
    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 concerned8
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Last patient last visit
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 126
    F.4.2.2In the whole clinical trial 126
    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)
    Subjects will continue with their previous treatment with approved medication according local practise.
    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 Decision2009-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-07
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