Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2005-004290-19
    Sponsor's Protocol Code Number:SP873
    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:2006-01-09
    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 number2005-004290-19
    A.3Full title of the trial
    A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease
    A.4.1Sponsor's protocol code numberSP873
    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 SponsorSchwarz Biosciences GmbH
    B.1.3.4CountryGermany
    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 Information not present in EudraCT
    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 nameRotigotine Nasal Spray
    D.3.2Product code ND1421
    D.3.4Pharmaceutical form Nasal spray, solution
    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.3.8INN - Proposed INNRotigotine hydrochloride
    D.3.9.1CAS number 125572-93-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 placeboNasal spray, solution
    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
    advanced-stage, idiopathic 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to assess the tolerability and safety of rotigotine nasal spray in subjects with advanced-stage idiopathic Parkinson’s disease.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the efficacy of rotigotine nasal spray.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Subject is informed and has been given ample time and opportunity to think
    about his/her participation and has given his/her written informed consent.
    2. Subject is willing and able to comply with all trial requirements.
    3. Subject is aged ≥30 years.
    4. Subject has idiopathic Parkinson disease, of more than 3 years in duration, as
    defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the
    following: resting tremor, rigidity, impairment of postural reflexes, and without
    any known or suspected cause of Parkinsonism.
    5. The investigator must observe the subject in both the “on” and “off” state and
    determines that the subject is Hoehn and Yahr stage II -IV in both the “on”
    and “off” state.
    6. Subject has a Mini Mental State Examination (MMSE) score of ≥ 25.
    7. Subject is expected to be on a stable dose of levodopa, either short-acting or
    sustained release (in combination with benserazide or carbidopa) for at least 28
    days prior to baseline (Visit 2) of at least 300mg/day, administered in at least 3
    intakes.
    8. Subject experiences end-of-dose “off” episodes despite attempts to optimize
    levodopa regimen.
    9. Subject has a UPDRS Part III in “off” state of at least 25 points.
    10. If the subject is receiving a dopamine agonist, entacapone, an anticholinergic
    agent (eg, benztropine, trihexyphenidyl, parsitan, procyclidine, biperiden), a
    monoamine oxidase (MAO) - B inhibitor (eg, selegiline, rasagiline), or a N-methyl-
    D-aspartate (NMDA) -antagonist (eg, amantadine), he/she is expected to be on
    a stable dose for at least 28 days prior to baseline (Visit 2).
    E.4Principal exclusion criteria
    1. Subject has previously participated in this trial or was assigned to treatment with
    rotigotine in a previous trial.
    2. Subject has participated in another trial of an investigational drug (or a medical
    device) within the last 30 days or is currently participating in another trial of an
    investigational drug (or a medical device).
    3. Subject has atypical Parkinson syndrome(s), symptomatic Parkinson syndrome(s)
    due to drugs (eg metoclopramide, flunarizine), metabolic neurogenetic disorders
    (eg, Wilson disease), encephalitis, cerebrovascular disease or neurodegenerative
    disease (eg progressive supranuclear palsy).
    4. Subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal
    tissue transplant.
    5. Subject has dementia, active hallucinations or active or treated psychosis. If
    subjects has hallucinations, he/she may participate if hallucinations are treated,
    and no symptoms occurred during the last 28 days.
    6. Subject is receiving therapy with any of the following drugs currently or has done
    so within 3 months prior to the hospital admission visit (Visit 2): MAO-A inhibitors
    (pargyline, phenelzine and tranylcypromine), tolcapone, budipine, reserpine or
    alpha-methyldopa.
    7. Subject is currently receiving CNS active therapy (eg, sedatives, hypnotics, anti-
    depressants, anxiolytics, atypical neuroleptics), unless the dose has been stable
    for at least 28 days prior to Visit 2 and is likely to remain stable until end of Visit 3.
    8. Subject has a current diagnosis of epilepsy, a history of seizures as an adult, a
    history of stroke or had a TIA within 1 year prior to Visit 1.
    9. Subject has clinically relevant hepatic dysfunction (as defined as a total bilirubin
    > 2.0mg/dL or ALT and/or AST greater than 2 times the upper limit of the
    reference range at Visit 1).
    10. Subject has clinically relevant renal dysfunction (serum creatinine > 2.0mg/dL
    [>178µmol/L] at Visit 1).
    11. Subject has clinically relevant cardiac dysfunction (any cardiac disorder which in
    the opinion of the investigator would put the subject at risk of clinically relevant
    arrhythmia) and/or myocardial infarction within 1 year prior to Visit 1.
    12. Subject has a QTc interval of ≥ 500ms at Visit 1 (the Bazett's correction must be
    used for the correction of the QT interval).
    13. Subject has symptoms of rhinitis or local disease or irritation of the nasal mucosa
    at Visit 2 or Visit 3.
    14. Subject has had intra-nasal treatment within 14 days prior to Visit 3.
    15. Subject has a history of symptomatic orthostatic hypotension, or systolic blood
    pressure less than 105mmHg at trial entry.
    16. Subject has a history of chronic alcohol or drug abuse within the last 6 months.
    17. Subject has a known or suspected hypersensitivity to any component of the
    investigational product or other nasal spray products.
    18. Subject is pregnant or nursing, or is of child bearing potential but (i) not
    surgically sterile or (ii) not using adequate birth control methods (including a
    highly effective method of birth control and at least 1 barrier method) or (iii) not
    sexually abstinent or (iv) subject is not at least 2 years post-menopausal
    19. Subject has any medical condition, psychiatric condition or laboratory abnormality
    that, in the opinion of the investigator, could jeopardize or would compromise
    the subject’s ability to participate in this trial.
    E.5 End points
    E.5.1Primary end point(s)
    • Adverse events, as reported spontaneously by the subject or observed by the
    investigator recorded during the trial.
    • Changes in blood pressure and heart rate (with special emphasis on potential
    orthostatic reactions), electrocardiograms, clinical laboratory values.
    • Changes in physical and neurological examination from Visit 2 to the Safety Follow-
    up Visit.
    • Proportion of subjects who complete the trial.
    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 Information not present in EudraCT
    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) 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 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) 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.8.5The 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 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 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
    The end of the trial is defined as the date of the last visit of the last subject completing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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 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 2006-01-09. 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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Following the trial subjects will continue normal treatment for that condition.
    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 Decision2006-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-06-23
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 12:22:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA