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    Summary
    EudraCT Number:2006-000391-32
    Sponsor's Protocol Code Number:20102D05
    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:2006-04-21
    Trial 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 number2006-000391-32
    A.3Full title of the trial
    A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD.
    A.3.2Name or abbreviated title of the trial where available
    Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease
    A.4.1Sponsor's protocol code number20102D05
    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 SponsorBritannia Pharmaceuticals Limited
    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 nameApomorphine Nasal Powder
    D.3.4Pharmaceutical form Nasal powder
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive name6aß - apomorphine-10,11-diol hydrochloride hemihydrate
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboNasal powder
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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
    To determine the safety and local tolerability of repeated once daily dosing with Apomorphine Nasal Powder 2 and 4 mg over a period of 12 weeks, in subjects with Parkinson’s disease.
    E.2.2Secondary objectives of the trial
    - To determine the effect of once daily dosing with Apomorphine (APO) Nasal Powder 2 and 4 mg in comparison with Placebo Nasal Powder based on time to alleviate a daily acute episode of Parkinsonian motor symptoms (’off’ episode) over a period of 7 days for each blinded week and compared to Baseline, in subjects with Parkinson's Disease (PD).
    - To determine the effect of once daily dosing with APO Nasal Powder 2 and 4 mg in comparison with Placebo Nasal Powder based on the UPDRS (Sections 18-31) rating scale recorded in the clinic at 15 and 30 min post dose at Visits 1, 2 and 3, in subjects with PD.
    - To determine the efficacy, safety and local tolerability of repeated once daily dosing with APO Nasal Powder 2 and 4 mg over a period of 48 weeks, in subjects with PD.
    - To assess changes in quality of life at Visit 7 and Visit 16 and compared to Baseline in subjects with PD.
    - To assess changes in non-motor symptoms between Baseline, Visit 7 and Visit 16 in subjects with PD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Screening Visit:

    1. Ability and willingness to give written informed consent

    2. Males and females aged 18 years and over

    3. History of Parkinson’s disease for at least 1 year prior to screening

    4. Documented medication for Parkinson’s disease for at least 6 months prior to screening

    5. Currently on established, stable treatment for Parkinson’s disease (i.e. unchanged in the last 4 weeks)

    6. Subjects naïve to subcutaneous apomorphine therapy. Subjects who have undergone apomorphine challenge for diagnostic purposes (but who have not used subcutaneous apomorphine therapy) may be included.

    7. At least one documented predictable or unpredictable daily acute episode of Parkinsonian motor symptoms (’off’ episode) that persists for longer than 30 minutes and resolves the same day

    8. Willingness to take oral domperidone as anti-emesis prophylaxis for the duration of the blinded phase of the study and if required during open label

    9. Willingness to agree not to change the dose of their usual Parkinsonian medication for the duration of blinded phase (except in the event of an emergency such as hospitalisation)

    10. Ability to communicate well with the Investigator and comply with the requirements of the study

    At Baseline Visit:

    1. Ability to complete the diary card satisfactorily

    At Visit 1:

    1. One documented predictable or unpredictable daily acute episode of Parkinsonian motor symptoms (’off’ episode) that persists for longer than 30 minutes and resolves the same day - as demonstrated by the mean duration of the monitored acute episode of motor symptoms for the last 6 days in the completed Screening and Baseline diary cards, respectively

    2. No clinically significant abnormal laboratory values or ECG findings which the Investigator considers would make the subject unsuitable for the study
    E.4Principal exclusion criteria
    At Screening and Baseline Visit:

    1. Participation in any clinical study within the 12 weeks prior to screening

    2. Subjects with respiratory depression, dementia, psychotic disease or hepatic insufficiency

    3. Subjects with known hypersensitivity to apomorphine, its derivatives or any excipients of the product (mannitol and ascorbic acid)

    4. Subjects who have an ‘on’ response to levodopa, which is marred by severe dyskinesia or dystonia

    5. Pregnant or lactating females, or those likely to become pregnant

    Additional Advice: The Investigator should exercise caution when administering apomorphine to subjects:

    · With renal, pulmonary or cardiovascular disease
    · Prone to nausea and vomiting
    · If elderly or debilitated
    · With pre-existing cardiac disease or taking vasoactive medicinal products
    · With Postural hypotension
    · Who have neuropsychiatric disturbances

    Apomorphine has been associated with somnolence, therefore subjects who experience somnolence must refrain from driving or operating machines.
    Coombs positive haemolytic anaemia has been reported in patients treated with levodopa. Haematology tests will therefore be performed regularly during the study.
    Women of child bearing potential entered into the the study should be using adequate contraception and instructed to inform the Investigator if at any time they suspect they are pregnant or intend to become pregnant.
    E.5 End points
    E.5.1Primary end point(s)
    The main efficacy endpoint is:· The time to initial improvement in the acute ‘off’ episode of Parkinsonian motor symptoms, as recorded in the diary card and in clinical assessments. The mean time for each subject in each treatment period will be calculated from the available data.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    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 Decision2006-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-01
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