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    Summary
    EudraCT Number:2011-005054-59
    Sponsor's Protocol Code Number:SYN115-CL02
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-13
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2011-005054-59
    A.3Full title of the trial
    A double-blind, randomized, placebo-controlled study of the safety and efficacy of SYN115 as adjunctive therapy in levodopa-treated Parkinson’s subjects with end of dose wearing off
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SYN115 in Parkinson’s disease
    A.3.2Name or abbreviated title of the trial where available
    (none)
    A.4.1Sponsor's protocol code numberSYN115-CL02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01283594
    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 SponsorBiotie Therapies 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 supportBiotie Therapies Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiotie Therapies AG
    B.5.2Functional name of contact pointUwe Meya
    B.5.3 Address:
    B.5.3.1Street AddressAeschenvorstadt 36
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4051
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number41612069205
    B.5.5Fax number41612069201
    B.5.6E-mailuwe.meya@biotie.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 nameSYN115 Tablets, 60 mg
    D.3.2Product code SYN115
    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 INNtozadenant
    D.3.9.1CAS number 870070-55-6
    D.3.9.2Current sponsor codeSYN115
    D.3.9.3Other descriptive nametozadenant
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    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
    To assess the efficacy of different fixed doses of SYN115 for reducing the mean total hours of awake time per day spent in the OFF state in patients with Parkinson's disease (PD) treated with levodopa who have end of dose wearing off
    E.2.2Secondary objectives of the trial
    To assess the effects of SYN115 on dyskinesia; to assess the effects of SYN115 on UPDRS scores; to assess investigator and patient impressions of PD severity and change
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of Parkinson’s Disease, consistent with the UK Parkinson’s Disease Society Brain Bank diagnostic criteria;
    Between 30 and 80 years of age at the time of study enrollment;
    Hoehn & Yahr stages 2-4 when in OFF state and less than or equal to 3 in the ON state;
    Must have a good response to levodopa in the opinion of the investigator and be taking at least 4 doses of a levodopa containing preparation per day;
    Must have been taking levodopa continuously for at least the previous 12 months and currently experiencing end-of dose “wearing-off” fluctuations with at least 2 ½ hours of OFF per day;
    Maintained on a regimen of anti Parkinson’s medications which has been stable for at least 4 weeks prior to screening;
    Dopamine agonists, COMT inhibitors and MAOB inhibitor are permitted;
    Achieved the following results for PD diary training, practice diary collection and baseline diary recordings- Achieved at least 75% diary concordance with an approved site trainer/rater in the 2 hour training session; Returned a valid 2-day (ie, 2 consecutive 24-hour periods) practice diary; Returned valid diary recordings for the 2 consecutive days preceding the baseline visit that indicate at least 2 ½ hours of OFF time on each of the 2 day
    Contraception: - Women of childbearing potential must use an acceptable method* of contraception starting 4 weeks prior to study drug administration and for a minimum of 1 month after study completion). Otherwise, women must be post menopausal (at least 1 year absence of vaginal bleeding or spotting) as confirmed by FSH greater than or equal to 40 mIU/mL or 40 IU/L or be surgically sterile; Men with a potentially fertile partner
    Able to understand and have signed an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form to participate in this study;
    Able to understand study requirements and able and willing to follow instructions, attend all required study visits, undergo all planned tests.
    E.4Principal exclusion criteria
    Any secondary or atypical Parkinsonism (eg, drug-induced, post stroke etc.);

    History of neurosurgical intervention for Parkinson’s disease;

    Treatment with apomorphine in the 30 days prior to screening;

    Current treatment with antipsychotics, however, quetiapine administered at doses of less than 100 mg per day is permitted if the patient has been on a stable dose for a minimum of 4 weeks prior to screening.

    Treatment with any other investigational drug within 5 half-lives or 30 days prior to screening (whichever is longer) or any investigational device within 30 days;

    Any other condition or clinically significant abnormal findings on the physical or neurological examination, medical and psychiatric history, at screening or at baseline that, in the opinion of the investigator, would make the subject unsuitable for the study or put the subject at additional risk or prejudice evaluation of safety and efficacy of study drug;

    A score of < 26 on the Mini-Mental State Examination (MMSE) at the screening visit;

    Subjects with a current episode of major depression (Subjects receiving treatment for depression with antidepressants may be enrolled if they have been on a stable dose of the anti-depressant for 4 weeks prior to randomization);

    Exposure to neuroleptics (antipsychotic drugs) > 1 month within the past 5 years, or any exposure within the past year (except for quetiapine, see exclusion criterion number 4);

    Women who are pregnant or lactating;

    History of hepatitis (B or C) or cholangitis of any origin;

    Hyperthyroidism or hypothyroidism, unless they meet all of the following conditions:
    a) They have received a stable dose of thyroid medication for at least 3 months prior to Baseline visit.
    b) TSH concentrations are normal or within 10% of the upper or lower limit of the normal range
    c) They are clinically euthyroid

    Orthostatic hypotension requiring medication;

    Any out-of-range laboratory value (other than liver function tests) at screening that have not been reviewed, approved, and documented as not clinically relevant by the investigator;

    Liver function tests must be within approximately 1.5X of the upper limit of normal range for AST, ALT, GGT and alkaline phosphatase;

    Have a known allergy or sensitivity to SYN115 components;

    Suicidal ideation on the C-SSRS of type 4 or type 5 in the past 3 months;

    Finding of malignant melanoma on full body skin examination;
    Subjects who are positive (give any positive answer after the gateway question) for a disorder on the modified Minnesota Impulsive Disorders Interview (mMIDI)
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Week 12 in the 2-day average of total awake time (hours/day) spent in the OFF state for the modified Intent To Treat (mITT) analysis set.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 12
    E.5.2Secondary end point(s)
    Change from baseline to Week 12 in:
    Number of hours spent in the ON state while awake based on subject-completed home diaries; Number of hours spent in the ON state without troublesome dyskinesia while awake based on subject-completed home diaries; UPDRS Part I; UPDRS Part II (Activities of Daily Living) score; UPDRS Part III score (ON), assessed approximately 2 to 3 hours after the last dose of levodopa; UPDRS total score from Part I, II and III; Clinical Global Impressions – Severity; Clinical Global Impression-Improvement; Patient Global Impression-Improvement
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Week 12
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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.8.2.4Number of treatment arms in the trial5
    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 concerned4
    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 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
    Argentina
    Canada
    Chile
    Ukraine
    United States
    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 years0
    E.8.9.1In the Member State concerned months8
    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.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    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 state75
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 400
    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 anti-Parkinson’s medications; IMP is not available for continued use after the study is completed.
    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 Decision2012-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-17
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