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    Summary
    EudraCT Number:2006-003732-30
    Sponsor's Protocol Code Number:NbT 01-06 / TULEP 1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-13
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-003732-30
    A.3Full title of the trial
    Transdermal Use of Lisuride in Early ParkinsonĊ½s Disease:
    A double blind, randomized,
    Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS
    A.3.2Name or abbreviated title of the trial where available
    Tulep I
    A.4.1Sponsor's protocol code numberNbT 01-06 / TULEP 1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number2006-003732-30
    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 SponsorNEUROBIOTEC GMBH
    B.1.3.4Country
    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 namelisuride TTS
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLisuride
    D.3.9.1CAS number 18016-80-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.1
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 2
    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.2.1.1.1Trade name mirapexin
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule, hard
    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 INNPramipexole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.088
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Diagnosys of Early-stage idiopathic Parkinson's Disease for longest 1 year
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    The first primary study objective is to investigate the superior efficacy of an optimized individual dose of transdermal Lisuride (dose range: 0.2 to 0.4 mg/24 h nominal release rate with patch sizes: 10 cm2 to 40cm2 every second evening) with placebo after 26 weeks, using a sum score of UPDRS parts II (activity of daily living) and III (motor symptoms).
    The second primary study objective is to demonstrate non-inferior efficacy of optimized individual dosages of transdermal Lisuride compared with oral Pramipexole (dose range: 1.1 mg to 3.3 mg / day) after 26 weeks, using a sum score of UPDRS parts II and III. The third primary study objective is to investigate the superior efficacy of optimized individual dosages of transdermal Lisuride compared to oral Pramipexole after 26 weeks, using a sum score of UPDRS parts II and III.The fourth primary study objective is to investigate the superior efficacy of optimized individual dosages of transdermal Lisuride compared to oral Pramipexole.
    E.2.2Secondary objectives of the trial
    to evaluate further efficacy criteria, quality of life, tolerability and safety of Lisuride TTS patch treatment in comparison to placebo and Pramipexole after 26 weeks of double-blind treatment;
    to evaluate efficacy criteria, quality of life, tolerability and safety of Lisuride TTS patch after 26 week open-label treatment between week 27 and week 52) by comparing two treatment regimens with the Lisuride patch (every second day vs. twice a week) as well as with the pooled data.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    QUALITA DELLA VITA
    ALTRI SOTTOSTUDI: Questionari e diari del paziente:
    1)UPDRS
    2)CGI
    3)PDSS
    4)MADRS
    5)PDQ 39
    6)EQ-5D
    7)ESS

    E.3Principal inclusion criteria
    a) Patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent
    b) Patient is willing and able to comply with all trial requirements
    c) Male or female outpatients
    d) Age > 30 years
    e) Patients with newly diagnosed early-stage of idiopathic Parkinson’s disease for longest 1 year (diagnosis based on the UK Parkinson Brain Bank Diagnostic Criteria for PD, see Appendix 16.3.8) who have not yet received Levodopa therapy (except Levodopa test)
    f) Minimum UPDRS motor score of > 12 points at Baseline Visit BL
    g) Mini Mental State Examination (MMSE) score of &#8805; 27
    h) Concomitant diseases are stable and well controlled by medication
    i) Female patients must have a negative pregnancy test within 7 days prior to or at Baseline and are required to practice an effective method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility. Effective method of birth control is defined as those which result in a low failure rate (i.e. Pearl Index less than 1% per year) when used consistently and correctly such as:
    &#61485; A hormonal oral, transdermal, or injectable contraceptive agent with a double-barrier method
    &#61485; An implantable contraceptive device with a failure rate less than 1% for at least 3 months prior to screening
    &#61485; Tubal Ligation,
    &#61485; Vasoectomized partner
    E.4Principal exclusion criteria
    a) Patient has non-idiopathic PD due to drugs (e.g. flunarizine, metoclopramide), metabolic neurogenetic disoders (e.g., Wilson’s disease), encephalitis, cerebrovascular disease or other forms of secondary or atypical Parkinsonism such as multisystem atrophy (MSA) or progressive supranuclear palsy)
    b) Significant neurological symptoms not accounted for by Parkinson’s disease
    c) Current diagnosis of epilepsy, history of seizures as an adult, history of stroke, or transitory ischemic attacks (TIA) within one year prior to the screening visit (visit VS)
    d) Patient has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplantation or other neurosurgery for Parkinson’s disease
    e) History of or active hallucinations or delusions including drug-induced hallucinations, e.g. by dopaminergic therapy
    f) Treatment with dopamine agonists within 28 days of the baseline visit (BL)
    g) Pre-treatment with Levodopa (except for diagnostic challenge)
    h) Pre-treatment during the last 3 months prior to baseline visit 2 or current treatment with MAO-A inhibitors (pargyline, phenelzine, tranylcypromine), reserpine, budipine, alpha-methyldopa
    i) Current treatment with CNS active therapy (e.g., sedatives, hypnotics, anti-depressants, anxiolytics, antipsychotics) unless the dose has been stable for at least 28 days prior to the baseline visit (BL) and is likely to remain stable for the duration of Part A of the study.
    j) Current treatment with medications which will be eliminated through the renal tubulus system or which inhibit the active renal tubulus secretion (e.g., cimetidine, amantadine)
    k) History or presence of dementia demonstrated by the Mini-mental status examination or clinically
    l) Presence of major depression according to DSM IV criteria
    m) Any evidence or suspicion of any cardiac valvulopathy or any other cardiac disorder which in the opinion of the investigator would put the patient at risk of clinically relevant arrhythmia and/or myocardial infarction, within the last 12 months
    n) Clinically relevant hepatic dysfunction as defined as total bilirubin > 2.0 mg/dl or ALT and/or AST greater than two times the upper limit of normal range
    o) Clinically relevant renal dysfunction as defined as creatinine > 2.0 mg/dl (> 178 &#956;mol/l)
    p) History of syncope and/or severe otherwise symptomatic orthostatic hypotension within the last year or a systolic blood pressure less than 105 mmHg at Screening Visit VS
    q) History of significant skin hypersensitivity to adhesive or other transdermal applications, or recent unresolved contact dermatitis
    r) Any medical or psychiatric condition or any other clinically significant laboratory abnormalities that, in the opinion of the investigator, would interfere with the appropriate conduct of the study
    s) Alcohol or drug abuse in the past three years
    t) Females of childbearing potential who are planning to become pregnant, who are pregnant or lactating and/or who are unwilling to use effective means of contraception
    u) Patient has previously participated in this trial or patient has previously been assigned to treatment in a trial with Lisuride TTS
    v) Participation in other clinical studies in the previous four weeks
    w) Pregnancy or lactation
    x) QTc > 470 ms at Visit 1 (Bazett correction must be used)
    E.5 End points
    E.5.1Primary end point(s)
    Primary:
    Unified Parkinson’s Disease Rating Scale (UPDRS): sum score of parts II+III:
    Absolute change from baseline (Visit BL) to Visit V26.
    Secondary:
    - UPDRS: scores of parts I, II, III, IV-A, IV-B, IV-C: changes from baseline to Visit V26
    - Responder defined by a > 30% improvement between baseline and Visit V26 in the sum score of UPDRS part II + III.
    - Parkinson’s Disease Sleep Scale (PDSS) total score: changes from baseline to Visit V26
    - Clinical Global Impressions (CGI): CGI-1: global ratings of severity, (difference Visit V26 – baseline (BL), frequency distributions of item 2 “change in condition“ (CGI 2) and “therapeutic effect” (CGI 3)
    - Montgomery-Asberg Depression Rating Scale (MADRS) changes from baseline to Visit V26
    - EQ-5D: Changes in the Health State score and the EQ-VAS between PDQ 39 baseline and Visit V26
    - Parkinson’s Disease Questionnaire (PDQ-39, quality of life) total score: Change from baseline to Visit V26
    The same efficacy outcome measures will be analyzed at Visit V52 (end of open-label long-term treatment), compared both to baseline of part A (Day 1, Visit BL) and B (Visit V27).
    - Epworth Sleepiness Scale (ESS): Changes in the total score between baseline and Visit.V26 / V52
    - Adverse event reporting
    - Clinical laboratory tests (hematology, blood chemistry, urinalysis)
    - Physical and neurological examination
    - Vital signs including symptomatic orthostatic hypotension
    - 12-lead ECG including QTc evaluation
    - Global rating of tolerability by the investigator (CGI)
    - Patients’ ratings of daytime sleepiness by use of the Epworth Sleepiness Scale (ESS): change from baseline and rate of patients with a post-baseline total score between 11 and 15 and > 15 (excessive daytime sleepiness)
    - Time to dropout due to intolerability until Visit V26 (double-blind phase) and Visit V52 (open-label long-term 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 No
    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.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 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) Yes
    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 concerned6
    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 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
    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 years2
    E.8.9.2In all countries concerned by the trial months0
    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) No
    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 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 2008-02-13. 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 350
    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 Decision2007-12-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-15
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