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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
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    The EU Clinical Trials Register currently displays   43800   clinical trials with a EudraCT protocol, of which   7272   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.
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    EudraCT Number:2008-007520-26
    Sponsor's Protocol Code Number:PROSPERA (Rasagiline)
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-11-13
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2008-007520-26
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to assess the Efficacy, Tolerability and Safety of Rasagiline in Subjects with Progressive Supranuclear Palsy (Phase III)
    A.4.1Sponsor's protocol code numberPROSPERA (Rasagiline)
    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 SponsorKlinikum der Universität München
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    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 Yes
    D. name Azilect
    D. of the Marketing Authorisation holderTEVA Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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.3.8INN - Proposed INNRasagilin
    D.3.9.1CAS number 161735-79-1
    D.3.9.3Other descriptive nameRASAGILINE MESILATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1 mg
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 placeboTablet
    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
    Progressive Supranuclear Palsy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10036813
    E.1.2Term Progressive supranuclear palsy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of Rasagiline using the PSP rating scale (PSPRS), aiming at a 33 % reduction of the reported deterioration (Golbe et al., 2007), i.e. a mean yearly increase of 6.5 instead of 9.7.
    To assess the need for additional L-DOPA therapy or the need to in-crease the dose of L-DOPA during the trial.
    E.2.2Secondary objectives of the trial
    Reduction of gait disturbances and postural stability (as documented with posturographic measurement)
    Clinical safety and tolerability will be assessed by findings of physical and neurological examination, laboratory variables, adverse events in-cidence, vital signs, ECG, assessment of survival time
    Number of Subjects (%) who discontinue the study
    Number of Subjects (%) who discontinue the study due to AEs
    Assessment of survival time
    Additional endpoints: Secondary efficacy variables also will include inci-dence of dysphagia, gastrostomia, depression and pneumonia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all inclusion criteria to be eligible:
    1.Clinical signs of PSP. Diagnosis will be made for patients with clini-cal probable PSP (Litvan et al., 1996). Patients will be included with PSP stage </= II (Golbe et al., 1997), at least with a PSPRS < 40 (Golbe et al., 2007) and according to the diagnostic criteria resumed after the NNIPPS trial (Bensimon et al., 2009)
    2.Patients, male or female, aged 50 to 80 years
    3.Subjects whose clinical condition at the time of enrolment does not or requires a low [< / = 500 mg /day] stable dose of L-DOPA for at least 2 weeks prior to study entry
    4.Capability and willingness to give written signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
    E.4Principal exclusion criteria
    1. No clinically probable PSP
    2. No written informed consent possible
    3. Age > 80 or < 50 years
    4. Dementia (MMSE  24)
    5. Subjects with clinically significant psychiatric illness, including major depression
    6. Subjects who have taken any experimental drugs within 60 days prior to baseline
    7. Subjects who have used sympathomimetics (including over-the-counter remedies – nasal or oral), dextromethorphan, pethidine or St. John’s wort within 7 days prior to baseline.
    8. Loss of postural reflexes (no independent walking possible, inability to stand unassisted, wheelchair-bound)
    9. Feeding tube / recommendation for a feeding tube
    10. Unintelligible speech
    11. History of brain disease (e.g. repeated strokes, cerebral tumour, hydrocephalus)
    12. MPTP exposure
    13. Oculogyric crisis
    14. Early severe autonomic failure
    15. Systemic disorder affecting the brain
    16. Women who are not postmenopausal (e.g. one year without men-strual periods) or surgically sterilized.
    17. Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
    18. Subjects who have used antidepressants, including selective sero-tonin re-uptake inhibitors, tricyclic and tetracyclic antidepressants (except amitriptyline <= 50 mg/day, trazodone < = 100 mg/day, ci-talopram < = 20 mg/ day, sertaline < = 100 mg/day and paroxetine < = 30 mg/day, escitalopram < = 10 mg/day) within 42 days prior to baseline
    19. Subjects who have used any drugs known to have been involved in a drug interaction via inhibition of hepatic CYP 1A2 within 30 days prior to baseline (cimetidine, ciprofloxacin, clarithromycin, enoxacin, erythromycin, fluvoxamine, isoniazide, nalidixic acid, norfloxacin, troleandomycin, zileuton)
    20. Subjects who have used MAO inhibitors including reserpine and methyldopa within three months prior to baseline
    21. Anti-emetic or antipsychotic medication with central dopamine an-tagonist activity (except quetiapine fumarate) within six months prior to baseline
    22. Participation in a clinical trial within the last 30 days prior to study start
    23. Unstable antiparkinsonian medication within 30 days before base-line
    24. Previous use of Rasagiline or Selegiline
    25. Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study par-ticipation (based on the investigator’s judgment). Such conditions might include cardiovascular, vascular diseases, pulmonary, he-patic impairment (Child-Pugh score > 5), renal, or metabolic diseases or malignancies as determined by medical history, physical examination, laboratory tests, or ECG
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure will be the integral of the PSPRS changes from baseline over time measured during visits at 3, 6, 9, 12 months

    The need for additional L-DOPA therapy or the need to increase the dose of L-DOPA during 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 No
    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. 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    End of study is the final examination of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state112
    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 Decision2009-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-06-14
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