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    Summary
    EudraCT Number:2009-013552-72
    Sponsor's Protocol Code Number:P05664
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-08-11
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-013552-72
    A.3Full title of the trial
    A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease
    A.3.2Name or abbreviated title of the trial where available
    PARADYSE - Monotherapy
    A.4.1Sponsor's protocol code numberP05664
    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 SponsorSchering-Plough Research Institute, a division of Schering Corporation
    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 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 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 namePreladenant
    D.3.2Product code SCH 420814
    D.3.4Pharmaceutical form Coated 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 INNPreladenant
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 10
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Azilect
    D.2.1.1.2Name of the Marketing Authorisation holderLundbeck (Schweiz) AG
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameAzilect
    D.3.4Pharmaceutical form Capsule, hard
    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 INNRasagiline mesylate
    D.3.9.1CAS number 161735-79-1
    D.3.9.3Other descriptive nameRASAGILINE MESYLATE
    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 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 placeboCoated tablet
    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 placeboCapsule, hard
    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
    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 efficacy objective of this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with early Parkinson's disease as measured by the sum of UPDRS Parts 2 and 3 scores. The primary safety objective of this trial is to evaluate the safety and tolerability of preladenant compared to placebo in subjects with early PD.
    E.2.2Secondary objectives of the trial
    The key secondary efficacy objective of this trial is to evaluate the efficacy of a range of preladenant doses compared to placebo in subjects with early PD as measured by the proportion of responders and by the UPDRS Part 2 scores.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects with a diagnosis of idiopathic PD for less than 5 years.
    a. Subject should have bradykinesia and at least one of the following symptoms:
    i. Muscular rigidity
    ii. Resting tremor (4 to 6 Hz)
    iii. Postural instability unrelated to primary visual, cerebellar, vestibular, or proprioceptive dysfunction
    b. If resting tremor is not present at screening, the rigidity and/or bradykinesia must be asymmetric.
    • Subject who is receiving amantadine and/or anticholinergics must have been on a stable regimen of treatment for at least the 4 weeks before Screening.
    • UPDRS Part 3 score of >= 10.
    • Hoehn and Yahr Stage must be <= 3.
    • 30 to 90 years of age. A subject may be of either gender and any race/ethnicity.
    • Results of Screening clinical laboratory tests (hematology, blood chemistries, and urinalysis) drawn within 3 weeks prior to Randomization, clinically acceptable to the investigator
    • Patient is either a male or a female of reproductive potential and agrees to use (or have their partner use) one of the listed highly effective methods of birth control or a female not of reproductive potential.
    E.4Principal exclusion criteria
    • A subject must not have a form of drug induced or atypical parkinsonism, cognitive impairment (ie, Montreal Cognitive Assessment [MoCA] score < 26), bipolar disorder, schizophrenia, or other psychotic disorder.
    • A subject must not have a history of repeated strokes with stepwise progression, repeated head injury, encephalitis and/or oculogyric crises on no drug treatment.
    • A subject must not have experienced a stroke within 6 months of Screening or have a persistent neurological deficit that may interfere with study assessments.
    • A subject must not have definite encephalitis, strictly unilateral features 3 years after being diagnosed with PD, other neurological features such as supranuclear gaze palsy, cerebellar signs, a Babinski sign with clear, clinically significant pyramidal tract involvement, frequent falls, hallucinations unrelated to medications, or presence of cerebral tumor or communicating hydrocephalus on neuroimaging (by history).
    • A subject must not have severe, symptomatic autonomic involvement unrelated to medications.
    • A subject must not have exposure to a known neurotoxin.
    • A subject must not have a history of sustained remission of their Parkinson’s symptoms.
    • A subject must not have failed to show a therapeutic response if a diagnostic levodopa (L dopa) challenge had been done with a large test dose ( > 500 mg) of L dopa (if malabsorption excluded).
    • A subject must not have been treated with L dopa or dopamine agonists for other than diagnostic purposes. If a subject has received L dopa or dopamine agonists for diagnostic purposes, he/she must not have received the L dopa or dopamine agonist within 30 days before Screening.
    • A subject must not have an untreated major depressive disorder meeting Diagnostic and Statistical Manual of Mental Disorders IV Text Revision criteria. (A subject who is successfully treated [Beck Depression Inventory, Version II {BDI II} score < 19] with stable doses of allowed antidepressant medications for at least the 4 weeks immediately before Screening is eligible.
    • A subject must not be at imminent risk of self-harm or harm to others, in the investigator’s opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).
    • A subject must not have a systolic blood pressure (BP) >=150 mm Hg OR diastolic BP >= 100 mm Hg at Screening or at a BP recheck prior to Randomization. Subjects may be on stable antihypertensive medication.
    • Cardiovascular Disease: A subject must not have had any clinically significant cardiovascular event or procedure for 6 months prior to Randomization.
    • Liver Enzymes: A subject must not have an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3 x the upper limit of normal (ULN) or total bilirubin (T BIL) >= 1.5 x ULN.
    • Liver Disease: A subject must not have a history of serologically confirmed hepatic dysfunction (defined as viral infection [Hepatitis A, B, or C; Epstein Barr virus {EBV}; cytomegalovirus {CMV}]) or a history of diagnosis of drug or alcohol induced hepatic toxicity or frank hepatitis. (If the subject has a negative history of any form of viral induced hepatitis, and if the LFTs meet the liver enzymes exclusion criterion, no serological tests for viral hepatitis are required for entry into the trial.) A subject who has a history of serologically confirmed EBV or CMV may be enrolled in the trial as long as his/her viral infection was not associated with hepatitis in the past, and his/her LFTs are normal at Screening.
    • Prohibited Concomitant Medications: A subject must not have received any treatment listed more recently than the indicated period before Randomization, or continue to receive any treatment listed during the trial, unless expressly prescribed by the investigator during the trial. (see table in protocol)
    • A subject must not have an average daily consumption of more than three 4 ounce glasses (180 mL) of wine or the equivalent.
    • A subject must not have poorly controlled diabetes ( eg, HbA1c > 8.5) or significantly abnormal renal function (eg, creatinine > 2.0 mg/dL) in the opinion of the investigator.
    • A subject must not have a severe or ongoing unstable medical condition (eg, any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence).
    • A subject must not have participated in any studies using preladenant.
    • A female subject must not be breast-feeding or considering breast-feeding.
    • A female subject must not be pregnant or intending to become pregnant.
    • A subject must not have been participating in any other clinical trial within 90 days, inclusive, of signing the informed consent form of the current trial.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Week 26 (End of Part 1 treatment) in the sum of the UPDRS Parts 2 and 3 scores.
    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 Yes
    E.6.10Pharmacogenetic Yes
    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 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) Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 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
    The overall trial ends when the last remaining subject has ended participation in the trial, by completing the trial, being discontinued from the trial, or being lost to follow-up. A subject is considered to have fulfilled participation when he/she has completed the last protocol-specified contact (eg, visits or telephone contacts).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 1000
    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 Decision2010-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-05-23
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