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    The EU Clinical Trials Register currently displays   44257   clinical trials with a EudraCT protocol, of which   7344   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-015161-31
    Sponsor's Protocol Code Number:P04938
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-29
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-015161-31
    A.3Full title of the trial
    A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's Disease
    A.4.1Sponsor's protocol code numberP04938
    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 holderTeva Pharma Gmb
    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.3.1Product 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 mesilate
    D.3.9.3Other descriptive nameRASAGILINE MESILATE
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    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 moderate to severe Parkinson's disease (PD) experienceing motor fluctuations and receiving a stable dose of levodopa (L-dopa), as measured by "off" time.
    E.2.2Secondary objectives of the trial
    The Key Secondary Efficacy Objectives for this trial are to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with moderate to severe PD experiencing motor fluctuations and receiving a stable dose of L-dopa as measured by "on" time without troublesome dyskinesia and by the proportion of Responders.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    • Each subject must have a diagnosis of idiopathic PD based on the following criteria:
    Each 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 (impairment of postural reflexes, eg, as assessed by the pull test) unrelated to primary visual, cerebellar, vestibular, or proprioceptive dysfunction
    • Each subject must have received prior therapy with L dopa for approximately 2 or more years immediately before Screening and must continue to have a beneficial clinical response to L dopa at Screening.
    • Each subject must have been on a stable, optimal dopaminergic treatment regimen, defined as maximum therapeutic effect achieved with available anti parkinsonian treatment, for at least the 4 weeks immediately before Randomization.
    • Subjects receiving the adjunct PD medications are permitted to enroll in this trial. Each subject who is receiving one or more of the adjunct PD medications listed below must have been on a stable regimen of treatment for at least the 4 weeks immediately before Randomization.
    Amantadine
    Anticholinergics
    COMT inhibitors
    Dopa decarboxylase inhibitors
    Dopamine agonists
    Entacapone
    L-dopa
    COMT: catechol-O-methyl-transferase
    • Each subject’s Hoehn and Yahr stage must be ≥ 2.5 to ≤4 when in the “off” state following optimum titration of treatment medications at Screening.
    • Each subject must be experiencing motor fluctuations AND dyskinesias following optimum titration of treatment medications and within the 4 weeks immediately before Screening.
    • Each subject must be experiencing a minimum of 2 hours/day of “off” time as estimated by the investigator and supported by the 3 day symptom diary (Daily Diary) at the Diary Training Visit.
    • Each subject, with or without the help of a caregiver, must be capable of maintaining an accurate and complete symptom diary (Daily Diary) as assessed at the Diary Training Visit.
    • Each subject (or subject’s legal representative) must be willing and able to provide written informed consent for the trial. For a subject who is unable to provide independent consent, a legal representative may provide written informed consent. Subjects who are unwilling to provide written informed consent for exploratory pharmacogenetic testing may be included in the trial; however, exploratory pharmacogenetic samples must not be obtained.
    • Each subject must be ≥30 to ≤85 years of age. A subject may be of either sex, any race/ethnicity.
    • Each subject must have results of Screening clinical laboratory tests (hematology, blood chemistries, and urinalysis) drawn within 3 weeks prior to Randomization, clinically acceptable to the investigator, and not within the parameters specified for exclusion (below).
    • Each subject must have results of a physical examination within normal limits or clinically acceptable limits to the investigator.
    • Each subject must be able to adhere to dose and visit schedules.
    • Each subject is either a male or:
    a) A sexually active female of reproductive potential and agrees to use (or have their partner use) one of the listed highly effective methods of birth control within the projected duration of the study: intrauterine device (IUD), condoms, diaphragm, vasectomy. The use of barrier contraceptive (condom or diaphragm) should always be supplemented with the use of a spermicide.
    Patients taking hormonal contraceptives may continue to use them during the trial, but must use one additional form of highly effective non hormonal contraception throughout the study period.
    OR
    b) A female not of reproductive potential.
    A female patient who is not of reproductive potential is defined as:
    One who has either (1) reached natural menopause (defined as ≥ 46 years old with
    (a) 12 months spontaneous amenorrhea or (b) 6 months of spontaneous amenorrhea with serum follicle stimulating hormone [FSH] levels in the postmenopausal range [> 40 IU/L] as determined by the central laboratory), (2) 6 weeks post surgical bilateral oophorectomy, (3) hysterectomy, or (4) bilateral tubal ligation.
    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. (Subjects with non-troublesome hallucinations, stable on low dose quetiapine or clozapine are allowed to enroll.)
    • 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 had surgery for PD.
    • A subject must not have an untreated major depressive disorder meeting Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM IV TR) criteria. (A subject who is successfully treated [Beck Depression Inventory II {BDI II} score < 19] with stable doses of allowed antidepressant medications for at least the 4 weeks immediately before Screening is eligible to enroll in the trial.)
    • 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). Subjects must be excluded if they report suicidal ideation of Type 4 or 5 in the past 2 months or suicidal behavior in the past 6 months as measured by the CSSRS during Screening or at Baseline.
    Blood Pressure: A subject must not have a systolic blood pressure (BP) >= 150 mm Hg OR diastolic BP >= 100 mm Hg at Screening and at a BP recheck prior to Randomization. Should the BP remain elevated, the subject may not enter the trial until the BP has been adequately controlled as demonstrated by 2 BP measurements meeting this criterion at consecutive separate visits within 3 weeks weeks 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, including, but not limited to, myocardial infarction, angioplasty, unstable angina, or heart failure; and a subject must not have heart failure staged New York Heart Association Class III or IV.
    • 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. Should a liver function test (LFT) be abnormal (AST/ALT > ULN but < 3 x ULN, T-BIL > ULN but < 1.5 x ULN) at Screening, the investigator should attempt to characterize at entry the reason(s) for elevation(s), eg, alcohol abuse (see next exclusion criterion), metabolic syndrome with fatty liver, etc. No repeat testing allowed.
    • 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. Types of serology assays to be performed are specified in the table of Laboratory Tests in the section on Trial Procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The Change from Baseline to End of Treatment (Week 12) in mean "off" time in hours per day.
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA73
    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
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 750
    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 Decision2010-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-20
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