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    Summary
    EudraCT Number:2010-020112-11
    Sponsor's Protocol Code Number:P07037
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-06
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2010-020112-11
    A.3Full title of the trial
    A Phase 3, 12-Week, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P07037)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)
    A.3.2Name or abbreviated title of the trial where available
    P07037
    A.4.1Sponsor's protocol code numberP07037
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01227265
    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 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 supportSchering-Plough Research Institute, a division of Schering Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSchering-Plough Research Institute, a division of Schering Corporation
    B.5.2Functional name of contact pointKenneth Wolski, MD
    B.5.3 Address:
    B.5.3.1Street AddressUG 4C-18, 351 Sumneytown Pike, PO Box 1000
    B.5.3.2Town/ cityNorth Wales, PA
    B.5.3.3Post code19454-2505
    B.5.3.4CountryUnited States
    B.5.4Telephone number001267305-3104
    B.5.5Fax number001267305-6640
    B.5.6E-mailkenneth.wolski@merck.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 namePreladenant
    D.3.2Product code SCH 420814
    D.3.4Pharmaceutical form Coated 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 INNPreladenant
    D.3.9.1CAS number 377727-87-2
    D.3.9.2Current sponsor codeSCH 420814
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 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 INNPreladenant
    D.3.9.1CAS number 377727-87-2
    D.3.9.2Current sponsor codeSCH 420814
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboCoated tablet
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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 the preladenant doses 2 mg twice daily and 5 mg twice daily compared with placebo in
    subjects with moderate to severe PD experiencing motor fluctuations and receiving a stable dose of 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 the preladenant doses 2 mg twice daily and 5 mg twice daily compared with placebo in subjects with moderate to severe PD experiencing motor fluctuations and receiving a stable dose of L-dopa, as measured by the proportion of Responders and by “on” time without troublesome dyskinesia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Each subject must have a diagnosis of idiopathic PD based on the United Kingdom Parkinson’s Disease Society Brain Bank Criteria (see Appendix 1) and the inclusion/exclusion criteria for this protocol. Each subject should have bradykinesia and at least one of the following
    symptoms:
    i. Muscular rigidity
    ii. Resting tremor (4 to 6 Hz; Please note that for the purposes of this
    study, a diagnosis based solely on bradykinesia and postural
    instability is insufficient for diagnosis of idiopathic Parkinson's
    Disease, and subjects diagnosed in this manner cannot be enrolled
    in the study).

    2. Each subject must have received prior therapy with L-dopa for approximately 1 or more years immediately before Screening and must continue to have a beneficial clinical response to L-dopa at Screening.

    3. 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 5 weeks immediately before Randomization.

    4. Subjects receiving the adjunct PD medications listed in Table 1 [Amantadine, Anticholinergics, Dopa decarboxylase inhibitors, Dopamine agonists, Entacapone, L-dopa] are permitted to enroll in this trial. Each subject who is receiving one or more of the adjunct PD medications listed in Table 1 must have been on a stable regimen of treatment for at least the 5 weeks immediately before Randomization.

    5. Each subject’s Hoehn and Yahr stage must be >=2.5 and ≤4 in the optimum “on” state at Screening

    6. Each subject must be experiencing motor fluctuations with or without dyskinesia following optimum titration of treatment medications and within the 5 weeks immediately before Screening.

    7. 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 Randomization.

    8. 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.
    E.4Principal exclusion criteria
    1. A subject must not have a form of drug-induced or atypical parkinsonism, cognitive impairment (ie, MoCA score <22), bipolar disorder, schizophrenia, or other psychotic disorder.

    2. A subject must not have a history of any of the following:
    • repeated strokes; • with stepwise progression of Parkinsonian features; • repeated head injury; • definitive encephalitis; • oculogyric crises; • neuroleptic treatment at onset of symptoms; • more than one first degree relative affected; • sustained remission; • strictly unilateral features after 3 years; • supranuclear gaze palsy; • cerebellar signs; • early severe autonomic involvement; • severe symptomatic autonomic involvement unrelated to medications; • early severe dementia with disturbances of memory, language, and; praxis; • Babinski sign with clear, clinically significant pyramidal tract involvement; • presence of cerebral tumor or communicating hydrocephalus on; neuroimaging (by history); • negative response to large doses of L-dopa (if malabsorption excluded); • MPTP (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine) or known neurotoxin; exposure; • hallucinations unrelated to medications; • stroke within 6 months of Screening or persistent neurological deficit that may; interfere with study assessments; • surgery for PD

    3. 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 or Beck Depression Inventory II] {BDI II} score ≥19. 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 45 weeks immediately before Screening is eligible to enroll in the trial.

    4. 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 Randomization Visits.

    5. In the judgment of the investigator, a subject must not have sleep attacks or compulsive behavior that would interfere with the integrity of the trial or would pose a risk to the subject in participating in the trial.
    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.5.1.1Timepoint(s) of evaluation of this end point
    2,4,8, and 12 weeks
    E.5.2Secondary end point(s)
    - The proportion of Responders, where a Responder is defined as a subject with at least a 30% reduction in mean "off" time from Baseline to Week 12.

    - The change from Baseline to Week 12 in mean "on" time without troublesome dyskinesia in hours per day
    E.5.2.1Timepoint(s) of evaluation of this end point
    2,4,8, and 12 weeks
    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 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 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.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Chile
    Colombia
    Croatia
    Latvia
    Lithuania
    Mexico
    Russian Federation
    Serbia
    South Africa
    Ukraine
    United States
    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 years1
    E.8.9.1In the Member State concerned months6
    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: 234
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 351
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 585
    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)
    No treatment with the IMP beyond the final scheduled visit will be allowed under the current protocol.
    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 Decision2011-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-16
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