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    The EU Clinical Trials Register currently displays   38870   clinical trials with a EudraCT protocol, of which   6391   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2010-023756-82
    Sponsor's Protocol Code Number:TUD-RaSPar-051
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-28
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2010-023756-82
    A.3Full title of the trial
    Rasagiline treatment for Sleep disorders in Parkinson´s disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test influence of parkinson drug of insomnia in parkinson patients
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberTUD-RaSPar-051
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDresden University of Technology
    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 supportTEVA GmbH
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Neurology
    B.5.2Functional name of contact pointStudy Assistence
    B.5.3 Address:
    B.5.3.1Street AddressFetscherstr. 74
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.4Telephone number00493514583876
    B.5.5Fax number00493514585802
    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.2.5The 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 No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 161735-79-1
    D.3.9.3Other descriptive nameRASAGILINE MESILATE
    D.3.9.4EV Substance CodeSUB21334
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    sleep disturbances/sleep disorders in patients with Parkinson´s disease
    E.1.1.1Medical condition in easily understood language
    insomnia in parkinson patients
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Reduction of sleep disturbances
    E.2.2Secondary objectives of the trial
    a) Changes in different sleep variables measured by PSG and clinical assessment
    b) Changes in sleep quality and daytime sleepiness assessed by standardized scales as well as cognitive function, depression indices and Quality of Life indices are measured.
    c) Rasagiline Safety assessment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Idiopathic Morbus Parkinson according United Kingdom BBB-Criterias
    • Male or female patients 50 to 85 years old
    • Hoehn and Yahr Stadium I-III
    • Relevant sleep disorder (> 5 PSQI)
    • Well adjusted antiparkinsonian medication about 4 weeks before inclusion
    • Patients, who are able and willing to complete questionaries
    • Patients who are able and willing to unterstand the relevance of the trial
    • Signed informed consent
    E.4Principal exclusion criteria
    • Known hypersensitivity to Rasagiline or other componets of Azilect or drugs with similar chemical structure
    • Atypical Parkinson syndrome
    • Pregnant or breastfeeding females
    • Females of childbearing potential (FCBP) except those fulfilling the following criterias:
    - post-menopausal (12 months of natural amenorrhea or 6 months of
    amenorrhea with serum FSH > 40 U/ml);
    - post-surgery (6 weeks after bilateral ovarectomy with or without hysterectomy);
    - regular and correct use of contraceptives with a PEARL Index of < 1%
    (e.g. implants, depot formulations of hormones, oral contraceptives, intra uterine device – IUD);
    - sexual abstinence;
    - partner, who had vasectomy
    • Intake, within the last 2 weeks before treatment, of: Amantadin, Monoaminoxidase-
    (MAO) inhibitors, SSRI, SNRI, trizyclical and tetrazyclical antidepressants, all
    neuroleptics except Clozapin and Quetiapin
    • Intake, within 4 weeks before inclusion, of:
    CYP P450 1A2 Inhibitors (e.g. Ciprofloxacin, Cimetidin, Clarithromycin,
    Erythromycin, systemic Estrogene, Fluvoxamin, Isoniazid, Ketokonazol,
    Levofloxacin, Norfloxacin, Mexiletin, Paroxetin, Propafenon, Zileuton, Disulfiram,
    Ginseng, Grapefruitjuice, Ephedrin, Pseudoephedrin)
    • Ongoing or terminated treatment within the last 2 weeks before inclusion
    with Opiates like Pethidin
    • Patients with a history of chronic drug abuse or another illness which does not
    allow the patient to assess the nature and/or possible consequences of the study
    • Neurological (other than PD) or psychiatric disorders which affect the patient´s
    functional status and/or judgement or ability to agree
    • Patients who are not likely to follow the trial protocol (lack of willigness to Cooperate)
    • Legal incapacity or limited legal incapacity
    • Epilepsy or epileptic seizure in the history
    • Known or ongoing alcohol or drug abuse
    • Deep brain stimulation (DBS), condition after deep brain stimulation
    • Significant renal or hepatic impairment
    • Participation in other clinical trial during this trial and within 4 weeks before
    • History of sleep related breathing disorder or severe OSAS as characterized by PSG (AHI >30n/h)
    • Severe depression (MADRS >35)
    • Known history of cardiac arrhythmias and instable angina pectoris

    E.5 End points
    E.5.1Primary end point(s)
    Change in sleep efficacy (TST/TIB %) and change in Parkinsons´s Disease Sleep Scale-2
    E.5.1.1Timepoint(s) of evaluation of this end point
    between evaluation at V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    E.5.2Secondary end point(s)
    Measured by PSG as:
    frequency of slow wave sleep (SWS) and REM sleep,
    sleep latency, REM latency,
    total sleep time (TST), total wake time (WASO),
    sleep fragmentation, arousal index,
    percentage of light sleep (stage 1,2) periodic limb movements in sleep (PLMS),
    Apnoe-Hypopnoe-Index (AHI), Respiratory-Distress Index (RDI) and
    nocturnal mobility assed by PSG video recording.
    Sleep quality and daytime sleepiness assessed by standardized scales (ESS, PSQI, number of diurnal naps) as well as cognitive function (PANDA, TAP), depression indices (MADRS) and QoL index (PDQ-39) are measured.
    Motor symptoms (full version of new Unified Parkinson’s Disease Rating Scale (UPDRS))
    Modified Hoehn&Yahr Scale
    Schwab and England ADL Scale
    Global Clinical Impression (GCI)
    ECG changes
    Safety laboratory values (Liver and renal function, electrolytes, WBC, RBC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    between evaluation at V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    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.8.2.4Number of treatment arms in the trial2
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    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 months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state30
    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)
    normal treatment
    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 Decision2011-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-30
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