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    Summary
    EudraCT Number:2004-001594-25
    Sponsor's Protocol Code Number:EMR62225-019
    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:2004-10-26
    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 ConcernedFinland - Fimea
    A.2EudraCT number2004-001594-25
    A.3Full title of the trial
    A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia
    A.3.2Name or abbreviated title of the trial where available
    PADDY 2
    A.4.1Sponsor's protocol code numberEMR62225-019
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 Information not present in EudraCT
    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.3.2Product code EMD128130
    D.3.4Pharmaceutical form Tablet
    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 INNSarizotan hydrochloride
    D.3.9.1CAS number 195068-07-6
    D.3.9.2Current sponsor codeEMD128130
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    Treatment-Associated Dyskinesia in Parkinson's Disease
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate efficacy of 1 mg Sarizotan HCl b.i.d. after 12 weeks and after 24 weeks (maintenance of efficacy) in the treatment of dyskinesia in Parkinson's disease.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to collect safety and tolerability data for 1 mg Sarizotan HCl b.i.d. in Parkinson patients.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.The subject has given his/her written informed consent to participate in the study.
    2.The subject is an out-patient aged 30 years or above.
    3.(For female subjects of child-bearing potential) The subject is using a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
    4.The subject presents with a diagnosis of idiopathic Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
    5.The subject presents with Stage 2.5 or above on the Hoehn and Yahr staging system.
    6.The subject's dyskinesia is present during more than 25% of the waking day (historical information in agreement with the assessment of the investigator according to item 32 of UPDRS).
    7.The subject's dyskinesia is at least moderately disabling (historical information in agreement with the assessment of the investigator according to item 33 of UPDRS).
    8.The subject has at least 4 ticks/day “ON time with dyskinesia” on each of the two days the diary was completed before the inclusion visit.
    9.The subject has participated successfully in a diary-card training session.
    10.All registered Parkinson drugs are allowed. The subject has been on a stable dose of anti-Parkinsonian drugs except L-dopa for a period of at least 8 weeks up to the screening visit.
    11.In the judgment of the investigator based on the subject’s history, previous treatments, and the investigator’s overall knowledge of PD, the subject is considered as being optimally treated at the present time (i.e., further adjustments of current medication will not further improve the subject's symptoms of Parkinson's disease).
    12.The subject has at least 4 ticks/day “ON time with dyskinesia” on each of the two days the diary was completed before the baseline visit.
    13.The subject shows adequate compliance with the instructions for filling in the diary.
    14.The subject shows adequate compliance with the schedule for intake of investigational product.
    E.4Principal exclusion criteria
    1.The subject has, within the four weeks up to inclusion, started treatment with any classical or atypical neuroleptics (including metoclopramide) and/or antidepressants and/or anxiolytics (including buspirone).
    2.The subject's dosage with any of the medications listed in (1) above has changed within the four weeks up to inclusion.
    3.Any commencement or change of dosage with any of the medications listed in (1) above during the study period is anticipated.
    4.(For female subjects) The subject is pregnant or lactating.
    5.The subject is participating in another clinical study or has done so within the past 30 days.
    6.The subject has participated in the SPLENDID study (EMR 62 225-001) or the SPIRID study (EMR 62 225-006).
    7.The subject has received neurosurgical intervention related to PD (e.g. deep brain stimulation, thalamotomy etc.) or is scheduled to do so during the study period.
    8.The subject has any clinically significant illness that, in the investigator's opinion, might interfere with the subject's ability to participate in the study.
    9.The subject has relevant renal impairment as measured by Creatinine >2 X ULN.
    10.The subject has relevant hepatic impairment as either measured by total bilirubin > 2 X ULN or by a history of moderate or severe hepatic insufficiency or of moderate or severe liver cirrhosis.
    11.The subject is suffering from any dementia or other psychiatric illness that prevents him/her from giving informed consent.
    12.The subject has legal incapacity or limited legal capacity.
    13.The subject has a history of allergic asthma. (Note: This is to minimize the risk of severe allergic reactions to ACTH following the stimulation test.)
    E.5 End points
    E.5.1Primary end point(s)
    A subject is defined as a responder if he improves at least 25% in the sum score of item 32 and 33 of the UPDRS compared to baseline at visit 3.
    The primary target variable is defined as a responder rate assessed at Visit 5 (Endpoint 1) and at Visit 7 (Endpoint 2).
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Date of last contact with subject; no study-specific examination or administration of investigational product after that date.
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2004-10-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 600
    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)
    An open follow-up study will be offered to participating subjects.
    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 Decision2004-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-03-22
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