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    Summary
    EudraCT Number:2005-000444-84
    Sponsor's Protocol Code Number:EMR62225-030
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-000444-84
    A.3Full title of the trial
    An open-label, multicenter, multinational Phase III
    follow-up study to investigate the long-term safety
    and efficacy of Sarizotan HCl 1 mg b.i.d. in
    patients with Parkinson's disease suffering from
    treatment-associated dyskinesia (PADDY-O)
    A.3.2Name or abbreviated title of the trial where available
    PADDY-O
    A.4.1Sponsor's protocol code numberEMR62225-030
    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
    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
    To demostrate the long term safety of Sarizotan HCl 1mg b.i.d. administered to Parkinson patients with dyskinesia
    E.2.2Secondary objectives of the trial
    To obtain information about the treatment´s long-term afficacy and the impact on management of Parkinson´s disease (treatment with L-dopa and/ or other anti-Parkinson´s disease drugs) in patients undergoing the study treatment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.The patient has participated in and completed the previous PADDY 1 or PADDY 2
    study.
    2. The patient has given his/her informed consent to participate in the PADDY-O study. [Note: The patient must have given written informed consent before any study-related activities are carried out.]
    3. Visit 8 of the PADDY study and the first visit of the PADDY-O study are on the same
    day or, if on different days, they are not separated by a period exceeding one month.
    4. (For females of child-bearing potential) The patient is using a reliable method of
    contraception AND gives a negative result in a serum β−HCG test for pregnancy at
    entry into the study.
    E.4Principal exclusion criteria
    1. The patient 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 patient'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. The patient experienced major tolerability problems during the PADDY study that
    were/are judged by the investigator as being sufficient to preclude participation in the PADDY-O study.
    5. Known hypersensitivity to ACTH. [In establishing this, the investigator should check the patient's records from the PADDY study.]
    6. (For female patients) The patient is pregnant or lactating.
    7. The patient is participating in another clinical study or has done so within the past
    30 days – apart from the PADDY 1 or PADDY 2 study.
    8. The patient has relevant renal impairment as measured by creatinine >2 × ULN (upper limit of normal).
    9. The patient has relevant hepatic impairment as measured by total bilirubin > 2 × ULN or has a history of moderate or severe hepatic insufficiency or has moderate or severe liver cirrhosis.
    10. The patient has received neurosurgical intervention related to PD (e.g. deep brain stimulation, thalamotomy etc.) or is scheduled to do so during the study period.
    11. The patient has any clinically significant illness that, in the investigator's opinion,
    might interfere with the patient's ability to participate in the study.
    12. The patient showed major non-compliance in respect of intake of study medication during the respective PADDY study.
    13. The patient is suffering from dementia, or any other psychiatric illness that prevents him/her from giving informed consent.
    14. The patient has legal incapacity or limited legal capacity.
    E.5 End points
    E.5.1Primary end point(s)
    There is no primary variable as such. Descriptive statistical methods will be applied; no hypostesis testing will be performed. The objective of the statistical processing will be to provide a summary of the safety data acquired in the course of the study, and to provide corresponding processing of the efficacy data.
    Safety variables wil be:- Adverse events- Withdrawals due to adverse events-Laboratory values (chemistry, hematology, endocrine)- Vital signs.
    The efficacy variables to be used are similar to those in the preceding studies PADDY 1 and PADDY 2:- UPDRS (Part IV) sum score of items 32 & 33- responder rate based on the sum score of items 32 & 33 UPDRS (Part IV)- Variables derived from the subject's diary: Time in the state ‘ON without dyskinesia’, Time in the state ‘ON with dyskinesia’, Severity of dyskinesia (mean value of the VAS scores), Cumulative VAS scores divided by total ON time, Time in the state OFF, Time in the state ASLEEP.- Modified AIMS, at rest and with provoked dyskinesia- Clinical and patient's global impression- UPDRS (Parts I to VI) in the ‘best ON’ state, including sub-analysis of Part III.
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 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
    l
    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 months
    E.8.9.1In the Member State concerned days
    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 2006-05-22. 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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 800
    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 Decision2005-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-10-23
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