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    Summary
    EudraCT Number:2006-002937-20
    Sponsor's Protocol Code Number:E2007-G000-309
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-002937-20
    A.3Full title of the trial
    Multi-centre, Randomised, Double-blind, Placebo-and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson s Disease Patients with Motor Fluctuations.
    A.3.2Name or abbreviated title of the trial where available
    E2007-G000-309
    A.4.1Sponsor's protocol code numberE2007-G000-309
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorEISAI LTD UK
    B.1.3.4CountryUnited Kingdom
    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 nameE2007
    D.3.4Pharmaceutical form Film-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.3.9.2Current sponsor codeER-155055-90
    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) 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.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 Entacapone
    D.2.1.1.2Name of the Marketing Authorisation holderORION CORPORATION
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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.3.4Pharmaceutical 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 INNEntacapone
    D.3.9.1CAS number 130929-57-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated 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
    Levodopa Treated Parkinson s Disease Patients with Motor Fluctuations
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of one dose strenght 4 mg of E2007 with that of placebo on motor function in patients with Parkinson s disease PD who are on optimised and stabilised therapy and experience end-of-dose wearing off motor fluctuations
    E.2.2Secondary objectives of the trial
    To demonstrate that the efficacy of entacapone on motor function in patients with PD who are on optimised and stabilised therapy and experience end-of-dose wearing off motor fluctuations, is consistent with what has been reported in other clinical trials. To compare the safety and tolerability of E2007 to that of placebo. Other To assess the efficacy of E2007 on levodopa iduced dyskinesias as measured by the Unified Parkinson s Disease Rating Scale UPDRS part IV dyskinesia items and the patient diary. To compare the effects of E2007 to that of placebo on levodopa use.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female patients with idiopathic PD fulfilling the UK Parkinson s disease Society Brain Bank diagnostic criteria, with a good response to levodopa. 2. Patients must have diagnosed with idipathic PD at 8805;30 years of age. In addition the onset of symptoms associated with Parkinson s disease must have occurred 8805;30 years of age. 3. Patients must have predictable moto fluctuations of the wearing OFF type with the presence of at least 2 hrs of OFF time during the waking day excluding the morning OFF time as evidenced by diary cards completed at screening and confirmed by diary data collected in the 3-day diaries completed before randomisation. 4. Before patients are randomised, they must be able to show that they are able to accurately complete the diary cards. During the diary-training period at Screeening Visit 1, there must be diary evidence of at least one transition of OFF to ON or from ON to OFF. 5. Patients must rate between II-IV on the Hoehn Yahr scale when in an OFF state. 6. Patients must be taking optimised levodopa plus dopamine decarboxylase inhibitors therapy according to the Investigator s opinion at least 3 times during the waking day not including bedtime/night time dose up to a maximum of 8 doses daily including bedtime/night time dose . 7.Patients who are treated with DA or MAOB inhibitors or other anti-PD drugs must be on optimised and stable doses for at least 4 weeks prior to the baseline visit and must remain stable throughout the study. Only levodopa dosage can be adjusted downwards in the first 6 weeks of the double-blind treatment phase. 8. In the Investigator s opinion, patients must be able to distinguish their own motor states and the absence or presence of troublesome or non-troublesome dyskinesias. 9. In the Investigator s opinion, patients are able to complete the study including the completion of the home diary cards and are capable of giving full written informed consent.
    E.4Principal exclusion criteria
    1. Pregnant or lactating women. 2. Women of child-bearing potential unless infertile including surgically sterile or practicing effective contraception e.g. abstinence, intrauterine device or barrier method plus hormonal method . These patients must have a negative serum 946;-human chorionic gonadotrophin 946;-HCG test at the initial screening visit Visit 1 and a negative urine pregnangy test at the baseline visit Visit 3 . These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of non-child bearing potential as determined by the Investigator. 3. Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual of Mental Disorders 4ht edition; DSM IV cirteria. 4. Patients with a past within 1 year or present history of psychotic symptoms requiring anti-psychotic treatment. Patients may be taking anti-depressant medication; however, the dose must be stable for 4 weeks prior to the Screening visit. Use of anti-psychotic medication including clozapine and quetiapine is prohibited. 5. Patients with a past within 1 year or present history of major depression, suicidal ideation or suicide attempts. 6. Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, haematological, endocrine or metabolic systems that might complicate assessment of the tolerability of the study medication. 7. Patients who have a past or present history of liver impairment, neuroleptic malignant syndrome, non-traumatic rhabdomyolysis or pheochoromocytoma. 8. Patients with significantly elevated liver enzymes abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit . 9. Patients with current or prior treatment within 4 weeks prior to the Screening visit with medication known to induce the enzyme CYP3A4 refer to section 9.8.2 for list of prohibited medications . 10. Current or prior treatment within 4 weeks prior to the Baseline visit with tolcapone, methyldopa, budipine, reserpine, quetiapine or intermittent use of either liquid forms of levodopa or subcutaneous apomorphine. 11. Current treatment with non selective MAOA/B or combination of selective MAOA and selective MAOB inhibitors. 12. Patients with a known hypersensitivity to the active substance or to any of the excipients of entacapone. 13. Patients with previous stereotactic surgery e.g. pallidotomy for PD or with planned stereotactic surgery during the study period. 14. Patients receiving or with planned next 6 months deep brain stimulation. 15. Patients who have received entacapone previously or are currently using entacapone. 16. Patients who have received an investigational product within 4 weeks prior to the screening visit or patients that have participated in a previous study with E2007. 17 Patients with clinically significant cognitive impairment Mini-Mental State Examination 24 or fulfilling DSM IV criteria for dementia due to PD . 18. Patients with conditions affecting the peripheral or central sensory system unless related to PD such as mild sensory or pain syndromes limited to OFF periods that could interfere with the evalutation of any such symptoms caused by the study drug. 19. Patients with any condition that would make the patient, in the opinion of the Investigaotr, unsuitable for the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to the Week 18 assessment in the mean total daily OFF time as measured by patient-completed home diary cards
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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.8.5The 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
    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 months3
    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 months3
    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 2007-01-10. 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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 455
    F.4.2.2In the whole clinical trial 900
    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 Decision2006-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-18
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