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    Summary
    EudraCT Number:2011-003486-15
    Sponsor's Protocol Code Number:SP0934
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-10
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-003486-15
    A.3Full title of the trial
    A multi-center, randomized, double-blind, placebo-controlled, parallel group, polysomnography study to investigate safety and efficacy of the rotigotine transdermal patch in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A sleep laboratory study to investigate the safety and efficacy of the rotigotine skin patch in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis
    A.4.1Sponsor's protocol code numberSP0934
    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 SponsorUCB 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 supportUCB BIOSCIENCES GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number492173 48 1515
    B.5.5Fax number492173 48 1572
    B.5.6E-mailclinicaltrials@ucb.com
    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 nameRotigotine
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    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 INNROTIGOTINE
    D.3.9.1CAS number 99755-59-6
    D.3.9.2Current sponsor codeRotigotine
    D.3.9.4EV Substance CodeSUB21254
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.25
    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.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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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.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 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 nameRotigotine
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    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 INNROTIGOTINE
    D.3.9.1CAS number 99755-59-6
    D.3.9.2Current sponsor codeRotigotine
    D.3.9.4EV Substance CodeSUB21254
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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.IMP: 3
    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 nameRotigotine
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    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 INNROTIGOTINE
    D.3.9.1CAS number 99755-59-6
    D.3.9.2Current sponsor coderotigotine
    D.3.9.4EV Substance CodeSUB21254
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.75
    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.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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 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 placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    D.8 Placebo: 3
    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
    Restless Legs Syndrome in patients with End Stage Renal Disease (ESRD)
    E.1.1.1Medical condition in easily understood language
    Restless Legs Syndrome in patients with End Stage Renal Disease (ESRD)
    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 14.1
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    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
    The primary objective of this trial is to demonstrate superiority of rotigotine against placebo in subjects with RLS and ESRD requiring hemodialysis.
    E.2.2Secondary objectives of the trial
    The secondary objective is to investigate the effect of rotigotine on quality of life and sleep in this patient population. In addition, safety and tolerability of rotigotine will be evaluated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
    2. Subject understands the investigational nature of the trial and is willing and able to comply with the trial requirements. Subject is willing to accept that he/she might be treated with placebo during the treatment period.
    3. Subject is able to apply/remove the trial patches correctly.
    4. Subject is male or female, and is ≥ 18 and ≤ 85 years of age.
    5. Subject has a body mass index (BMI) of ≥ 18kg/m2 and 40kg/m2.
    6. Subject has end-stage renal disease (ESRD) requiring hemodialysis and has been on a regular dialysis schedule for at least 3 months prior to Screening (Visit 1)
    7. Subject has hemoglobin concentration of ≥ 8g/dL(4.97mmol/L) at Screening (Visit 1)
    8. Subject has ferritin concentration of ≥ 100ng/mL at Screening (Visit 1)
    9. Subject has a diagnosis of RLS based on the 4 cardinal diagnostic clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG):
    a. An urge to move legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs (The urge to move can be present without uncomfortable sensations. Arms or other body parts can also be affected.).
    b. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
    c. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
    d. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present.).
    10. Subject has had an initial response to previous dopaminergic treatment for RLS, or has had no previous dopaminergic treatment (ie, de novo).
    11. At Baseline (Visit 2), subject has a score of ≥15 points on the IRLS (indicating moderate to severe RLS).
    12. At Baseline (Visit 2), subject has a score of ≥11 points on the RLS-DI (Diagnostic Index).
    13. At Baseline (Visit 2), subject has a score of ≥4 points on the CGI Item 1 assessment (indicating moderately ill).
    14. At Baseline (Visit 2), subject scores ≥15 PLMs per hour on the PLMI based on PSG (recorded during the second night) as assessed by the investigator.
    E.4Principal exclusion criteria
    2. Subject has narcolepsy or other hypersomnia (including sleep attacks/sudden onset of
    sleep), either observed during local PSG, Multiple Sleep Latency Test (MSLT), or
    Maintenance of Wakefulness Test (MWT) or evidenced by subject history.
    3. Subject has clinically relevant polyneuropathy or varicosis which cannot be clearly differentiated from RLS symptoms in the opinion of the Investigator.
    4. Subject has additional clinically relevant concomitant diseases, such as attention deficit hyperactivity disorder, akathisia, painful legs and moving toes.
    5. Subject has other central nervous system diseases such as Parkinson’s disease, dementia, progressive supranuclear paresis, multisystem atrophy, Huntington’s Chorea, amyotrophic lateral sclerosis, or Alzheimer’s disease.
    6. Subject has evidence of an impulse control disorder according to the modified Minnessota Impulsive Disorders Interview (mMIDI) at Screening (Visit 1).
    7. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (‘Yes’) to either Question 4 or Question 5 of the C-SSRS at Screening. (Visit1) or Baseline (Visit 2).
    8. Subject has a prior history of psychotic episodes.
    9. Subject has a history of chronic alcohol or drug abuse within the last 12 months.
    10. Subject has any medical or psychiatric condition, which in the opinion of the investigator, can jeopardize or would compromise the subject’s well-being or ability to participate in this trial.
    11. Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to Baseline (Visit 2).
    12. Subject has clinically relevant cardiovascular disease which in the opinion of the Investigator could compromise the subject’s well-being or ability to participate in this trial.
    13. Subject has clinically relevant venous or arterial peripheral vascular disease.
    14. Subject has a malignant neoplastic disease requiring therapy within 12 months prior to Screening (Visit 1).
    15. Subject is currently receiving treatment with any of the following drug classes: neuroleptics, norepinephrine and dopamine reuptake inhibitors (bupropion), gabapentin, budipine, dopamine antagonist antiemetics (except domperidone), opioids, monoamine oxidase (MAO) inhibitors, catechol O methyltransferase (COMT) inhibitors, or psychostimulants (eg, amphetamines). If subject has received such therapy, a Washout Period of at least 7 days prior to Baseline (Visit 2) is required before starting treatment in this study.
    16. Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combined effective methods of contraception (including at least 1 barrier method), unless sexually abstinent.
    17. Subject pursues shift work or performs other continuous non-disease-related life conditions which do not allow regular sleep at night.
    18. Subject has had previous treatment with dopamine agonists within a period of 14days prior to Baseline (Visit 2), or L-dopa within 7 days prior to Baseline (Visit 2).
    19. Subject has a medical history indicating intolerability to dopaminergic therapy (if pre-treated) or has experienced augmentation when previously treated with any dopaminergic agent.
    20. Subject has received previous treatment with rotigotine.
    21. Subject has participated in another trial of an investigational drug within the last 28 days prior to Baseline (Visit 2) or is currently participating in another trial of an investigational drug.
    22. Subject has a known hypersensitivity to any of the components of the trial medication, such as a history of significant skin hypersensitivity to adhesives, known hypersensitivity to other transdermal medications or has unresolved contact dermatitis.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of the Periodic Limb Movements Index (PLMI) at the end of the Maintenance Period compared to Baseline in terms of the ratio from Baseline to the end of the 2-week Maintenance Period in PLMI (periodic limb movements [PLMs]/total time in bed) as
    measured by PSG
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to the end of the 2-week Maintenance Period
    E.5.2Secondary end point(s)
    • PLMI (PLMs/total time in bed)
    • International Restless Legs Scale (IRLS) sum score
    • Clinical Global Impressions (CGI)-Item 1score
    • Individual RLS-6 Rating Scales
    • Periodic Limb Movement during Sleep Arousal Index (PLMSAI)
    • Sleep efficiency (%)
    • RLS-QoL
    • SF-36
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary variables will be measured as Change from Baseline to the end of the 2-week Maintenance Period.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Finland
    France
    Germany
    Italy
    United States
    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
    last visit of the last subject (LVLS)
    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 months1
    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 months1
    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.1.2.1Number of subjects for this age range: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 48
    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)
    Please refer to the following sections of the protocol:

    - 5.1.1 Study duration per subject

    - 8.6 Safety Follow-up visit

    - 11.1.4 Follow up on adverse events
    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 Decision2012-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-29
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