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    Summary
    EudraCT Number:2006-005509-79
    Sponsor's Protocol Code Number:VR040/2/003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-12-07
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-005509-79
    A.3Full title of the trial
    A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease
    A.4.1Sponsor's protocol code numberVR040/2/003
    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 SponsorVectura Group plc
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/349
    D.3 Description of the IMP
    D.3.1Product nameapomorphine hydrochloride
    D.3.2Product code VR040
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNapomorphine hydrochloride
    D.3.9.1CAS number 41372-20-7
    D.3.9.2Current sponsor codeVR040
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3200 to 9000
    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 placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Parkinson's Disease patients who have motor fluctuations with recognisable motor “off” periods
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To explore the efficacy of VR040 in controlling “off” periods as measured by the primary and secondary efficacy criteria in patients with idiopathic PD who have motor fluctuations with recognisable motor “off” periods.
    •To compare the efficacy of VR040 with that of placebo.
    •To explore the safety/tolerability profile of VR040 as measured by the incidence and severity of spontaneously reported adverse events (AEs), vital signs, electrocardiograms (ECGs), lung function, and laboratory test results.
    •To explore the PK profile of VR040.
    •To verify that patients with idiopathic PD have sufficient dexterity and inspiratory effort to operate the Aspirair® inhaler satisfactorily.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to enter the study, patients must meet all of the following criteria:
    1.Male and female patients between 30 and 90 years of age with a clinical diagnosis of idiopathic PD for at least 5 years duration
    2.Provides voluntary written informed consent
    3.Is willing and able to comply with study procedures
    4.Fulfils steps 1 & 2 of the UK Brain Bank Criteria (Appendix 3)
    5.Classifies as Hoehn & Yahr Stage II-IV in “on” state (Appendix 4)
    6.Experiences motor fluctuations with recognisable “off” periods in control of motor symptoms, as assessed by the Motor Fluctuation Questionnaire. Patients should report at least 1 “Yes” response to the questions in the Motor Fluctuation Questionnaire (Appendix 5)
    7.Has received optimised oral therapy including LD 300-1500 mg per day (in combination with decarboxylase inhibitors) for at least the 30 days before Screening. For patients receiving controlled-release (CR) formulations, the dose range is based on a 70% bioavailability adjustment (ie, 100 mg CR = 70 mg non-CR)
    8.Shows dopaminergic responsiveness as defined by ≥30% improvement (reduction) in UPDRS III score compared to pre-dose value
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    1.Participation in a trial with an investigational product within 3 months prior to Visit 1
    2.Serious uncontrolled disease, including serious psychological disorders likely to interfere with the study and/or likely to cause death within 6 months of the study completion
    3.Previous intolerance to apomorphine
    4.Previous significant complication from oral dopamine agonist therapy including hospitalisation following dopamine agonist introduction and/or the development of hallucinations or other adverse neuropsychiatric features. Specific severe mental side effects include compulsive behaviour, psychosis, or hallucination that led to withdrawal of oral dopamine agonist therapy.
    5.Women during the lactation period, pregnancy or of childbearing potential not using a reliable contraceptive method (eg, barrier, intrauterine device, abstinence)
    6.Known human immunodeficiency virus or active chronic hepatitis B or C infection
    7.Any clinically significant abnormality following review of screening laboratory data, previous medical history/intercurrent illness, and full physical examination, which may compromise the safety of the patient in the study
    8.In the investigator’s opinion, the patient is unsuitable for the study for any reason.
    9.ECG abnormalities that, in the opinion of the investigator, would preclude study entry.
    10.FEV1 ≤ 65% predicted
    11.A postural decrease in systolic blood pressure of ≥20 mmHg, or showing significant clinical symptoms associated with orthostatic hypotension
    12.Persistent arterial hypotension, with average systolic readings of ≤110 mmHg
    13.Persistent elevation of blood pressure, with average systolic readings of ≥160 mmHg or average diastolic readings of ≥100 mmHg
    14.Taking prohibited concomitant medications (Section 7.2)
    15.Consumption of anabolic steroids or antipsychotics. Administration of the following low dose atypical antipsychotics is permitted:
    • Quetiapine (up to and including 50 mg per day)
    • Risperidone (up to and including 1 mg per day)
    • Olanzipine (up to and including 2.5 mg per day)
    16.Consumption of the 5HT3 antagonist class including ondansetron, granisetron, dolasetron, palonosetron, and alosetron
    17.Existing cancer and those in remission for less than 5 years
    18.Evidence as ascertained from examination, tests or history to indicate cardiovascular, gastrointestinal tract, liver, kidneys, central nervous system, pulmonary system or bone marrow disorders that, in the investigator’s opinion, compromises patient safety
    19.Known non-responders to apomorphine treatment for “off” episodes, eg, in previous challenge tests or trials
    20.History of drug or alcohol abuse in the 12 months prior to entry
    21.A history of clinically significant allergies to VR040 formulation constituents (including lactose and opioids) or domperidone
    22.Signs or symptoms suggestive of psychosis, dementia, “Parkinson-plus” syndromes, or unstable systemic disease
    23.History of stroke, seizure, or other neurological conditions
    24.Patients with dyskinesia rated 4 in Item 32 of UPDRS IV assessment at Screening (dyskinesia present ≥76% of a waking day)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is calculated for each patient as the maximum change in the UPDRS III score from pre-dose to post-dose score. This relates to the highest dose received by an individual patient. The UPDRS III data will be collected during Screening and Visits 1 and 2.
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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 concerned8
    E.8.5The trial involves multiple Member States No
    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 No
    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 patient, 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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 42
    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 Decision2006-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-29
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