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   43851   clinical trials with a EudraCT protocol, of which   7283   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:2004-001589-42
    Sponsor's Protocol Code Number:Tulir 02/01
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2004-11-19
    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 ConcernedAustria - BASG
    A.2EudraCT number2004-001589-42
    A.3Full title of the trial
    Transdermal lisuride:
    Phase II/III study (efficacy and tolerance) of transdermal lisuride (patches) in patients with Restless Legs Syndrome (RLS)
    A.4.1Sponsor's protocol code numberTulir 02/01
    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.1.3.4CountryGermany
    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.2.1.1.1Trade name Dopergin
    D.2.1.1.2Name of the Marketing Authorisation holderSchering
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.2Product code NBt P 102 DZ
    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.3.9.2Current sponsor codeLisuride
    D.3.9.3Other descriptive nameLisuride TTS
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients suffering from Restless Legs Syndrome (RLS)
    MedDRA Classification
    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 study objective is to investigate the efficacy of three different dosages of Lisuride TTS patches compared to placebo after 12 weeks of treatment in patients with idiopathic or uremic RLS. Changes in the IRLS total score are used as primary efficacy outcome measure.
    E.2.2Secondary objectives of the trial
    The secondary study objectives are:
    1) to evaluate quality of life, tolerability and safety of Lisuride TTS patch treatment in comparison to placebo after 12 weeks of double-blind treatment
    2) to assess long-term efficacy, quality of life, tolerability, and safety of open-labeled treatment with Lisuride TTS patches after 12 months, and to determine the effective dosage of Lisuride TTS in open-labeled application.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Male and female patients, between 18 and 80 (inclusive) years of age.
    - Diagnosis of idiopathic or uremic restless legs syndrome based on the four essential clinical features according to the International Restless Legs Study Group (IRLSSG).
    - RLS Diagnostic Index (RLS-DI) >= 10
    - Total score in the IRLS Rating Scale >= 15 at baseline
    - RLS-6 score “severity during the day at rest) >= 3
    - Patient has no previous treatment for RLS (de novo patients) or patient is not well controlled with current therapy.
    E.4Principal exclusion criteria
    1. Secondary restless legs syndrome due to, eg, iron deficiency anemia, rheumatoid arthritis. However, patients with secondary RLS due to renal insufficiency (uremia) are allowed to participate in this study.
    2. Secondary Restless Legs Syndrome due to previous or concomitant therapy with dopamine D2 receptor antagonists, butyrophenones, metoclopramide, atypical antipsychotics (eg, olanzapine), tri- and tetracyclic antidepressants, mianserine, lithium or H2-blockers (eg, cimetidine), or due to withdrawal from drugs such as anticonvulsants, benzodiazepines, barbiturates and other hypnotics.
    3. History of sleep disturbances like sleep apnea syndrome, narcolepsy, myoclonus epilepsy observed during PSG or explored in patient history.
    4. Further clinically relevant concomitant diseases: polyneuropathy, akathisia, claudication, varicosis, painful leg and moving toes, radiculopathy, fibromyositis, severe chronic lung disease, insulin-dependent diabetes mellitus, leukemia, anemia, primary amyloidosis.
    5. Other central nervous diseases such as: dementia, progressive supranuclear palsy, multi-system atrophy, Chorea Huntington, amyotrophic lateral sclerosis, dementia (eg, Alz-heimer’s disease), Isaac’s syndrome, Stiff-Man syndrome.
    6. Use of drugs likely to influence sleep architecture or motor manifestations during sleep within the last week before baseline visit. These include levodopa, other dopamine ago-nists, neuroleptics, hypnotics (except oxazepam, see Section 8.6.3), benzodiazepines, MAO inhibitors, antidepressants (except SSRI and NARI), anxiolytic drugs, anticonvul-sants, psychostimulant medications, and opioides. Inclusion is possible, if a >= one week wash-out is performed (if medically acceptable) before baseline; for pre-treatments with dopamine agonists, a four-week washout period is required.
    7. Myocardial infarction within 3 months before randomization; other clinically significant heart conditions (eg, instable coronary artery disease or other severe disturbances of pe-ripheral circulation and coronary insufficiency) and other severe health conditions for which it can be assumed that the effect of the study drugs will not be normal (eg, severe respiratory problems, hypothyreosis, active neoplastic disease).
    8. History of hallucinating or psychotic episodes which had needed treatment (including schizophrenia).
    9. Severe acute disease within the last 4 weeks prior to the first study drug administration.
    10. Clinically relevant presence of iron deficiency (as a rule as indicated by measures of ferri-tine below the lower boundary of the central laboratory).
    11. Clinically significant liver failure (total bilirubin >2.0mg/dl or SGOT and/or SGPT greater than two times the upper limit of the reference range).
    12. Clinically relevant renal dysfunction (serum creatinine >2.0 mg/dl) except in patients with uremic RLS who need at least two, usually three hemodialyses per week.
    13. Known hypersensitivity to lisuride or patches (band-aid, Leukoplast, Tesafilm (Scotch tape), etc).
    14. Pretreatment with lithium carbonate within 2 months prior to screening.
    15. Patients doing shift-work or is subject to other continuous non-disease-related life condi-tions which do not allow regular sleep at night .
    16. Pregnancy or lactation.
    17. Use of experimental drugs and/or participation in another clinical trial within 4 weeks be-fore study.
    18. Suspected irregular application of medication.
    19. Suspicion of present drug or alcohol abuse.
    20. Inability to understand the planned study.
    21. Clinically relevant ECG findings.
    22. Clinically relevant findings, especially skin disorders on application area (eg, psoriasis).
    E.5 End points
    E.5.1Primary end point(s)
    Changes between Baseline and Visit 6 (Week 12 / Day 85)
    in the total score of the IRLS total score will be analyzed
    as a primary endpoint, and compared against the 4 different groups.
    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 No
    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) 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 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
    Not applicable
    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 months4
    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 months8
    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 2004-11-19. 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 200
    F.4.2.2In the whole clinical trial 200
    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)
    Not applicable
    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 Decision2004-12-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-25
    P. End of Trial
    P.End of Trial StatusOngoing
    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-Sat Apr 20 03:37:36 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA