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    Summary
    EudraCT Number:2012-002608-42
    Sponsor's Protocol Code Number:PD0004
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-01
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-002608-42
    A.3Full title of the trial
    A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease
    A.4.1Sponsor's protocol code numberPD0004
    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 pointSigrid Nilius
    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 number492173481284
    B.5.5Fax number492173481572
    B.5.6E-mailsigrid.nilius@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 Yes
    D.2.1.1.1Trade name Neupro
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Manufacturing Ireland Ltd.
    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.3.1Product 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.3.9.4EV Substance CodeSUB21254
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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 Yes
    D.2.1.1.1Trade name Neupro
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Manufacturing Ireland Ltd.
    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.3.1Product 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.3.9.4EV Substance CodeSUB21254
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number13.5
    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 Yes
    D.2.1.1.1Trade name Neupro
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Manufacturing Ireland Ltd.
    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.3.1Product 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.3.9.4EV Substance CodeSUB21254
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson’s disease
    E.1.1.1Medical condition in easily understood language
    Degenerative disease of the nervous system
    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 PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    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
    To assess the effects of Rotigotine over placebo on improvement of Parkinson’s disease associated chronic pain in subjects with advanced-stage Parkinson’s disease experiencing Parkinson’s disease associated chronic pain.
    E.2.2Secondary objectives of the trial
    To demonstrate that Rotigotine is effective on Parkinson’s disease associated chronic pain intensity and characterization, quality of life, depression, anxiety, and motor function in subjects with advanced-stage Parkinson’s disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject.
    2. Subject is considered reliable and capable of adhering to the protocol, visit schedule, completion of the diary, and medication application according to the judgment of the investigator.
    3. Subject is male or female and ≥18 years of age at the Screening Visit.
    4. Subject has idiopathic Parkinson’s disease, defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes, and without any other known or suspected cause of Parkinsonism.
    5. Subject is taking levodopa (either immediate or sustained release, in combination either with benserazide or carbidopa) with a stable daily dose of at least 200mg for at least 21 days prior to starting the documentation in the diary. The dose is expected to be maintained for the duration of the study.
    6. Subject has a Hoehn and Yahr stage score of II to IV in the “on” state at the Screening Visit.
    7. Subject is experiencing chronic pain associated with Parkinson’s disease for at least 3 months and of at least 4 points on an 11-point Likert Pain Scale (average pain experienced during last 7 days) at the Screening Visit. Pain characteristics with at least 1 kind of Parkinson’s disease pain to be included:
     Dystonia
     Musculoskeletal pain
     Central neuropathic pain
     Other pains worsened by Parkinson’s disease (except dyskinesia)
    8. Subject has a Mini-Mental State Examination (MMSE) score ≥25 at the Screening Visit.
    9. If the subject is taking a monoamine oxidase (MAO)-B inhibitor, an anticholinergic agent, the catechol-O-methyl transferase (COMT) inhibitor entacapone or the N-methyl-D aspartate (NMDA) antagonist amantadine, he/she must have been on a stable dose for at least 21 days prior to starting the documentation in the diary, and the dose is expected to be maintained for the duration of the study.
    10. If the subject is taking an antidepressant drug such as a selective serotonin reuptake inhibitor, serotonin norepinephrine reuptake inhibitor, bupropion, or tricyclic antidepressants, he/she must have been on a stable dose for at least 21 days prior to starting the documentation in the diary, and the dose is expected to be maintained for the duration of the study.
    11. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of rotigotine (or longer, if required by local regulations).
    E.4Principal exclusion criteria
    1. Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study.
    2. Subject has participated in another study of an investigational medicinal product (IMP) (or a medical device) within the last 28 days prior to the Screening Visit or is currently participating in another study of an IMP or a medical device.
    3. Subject has had therapy with a dopamine agonist within 21 days prior to starting the documentation in the diary.
    4. Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator.
    5. Subject is receiving therapy with any of the following medications within 21 days prior to starting the documentation in the diary: dopamine modulating substances (eg, reserpine), dopamine releasing substances (eg, methylphenidate, amphetamine), alpha-methyldopa, metoclopramide, budipine, tolcapone, Duodopa®, neuroleptics (including atypical neuroleptics), MAO-A inhibitors, opioids, and opiates.
    6. Subject is receiving analgesics for the treatment for pain, unless the dose has been stable for at least 21 days prior to starting the documentation in the diary and the dose is likely to remain stable for the duration of the study.
    7. Subject has a history of chronic alcohol or drug abuse within the last 6 months.
    8. Subject has any medical or psychiatric condition (eg, bipolar disorder, dementia, hallucinations, or psychosis) that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate in this study.
    9. Subject has a known hypersensitivity to any components of the IMP or comparative drugs as stated in the protocol.
    10. Subject has a lifetime history of suicide attempt (including an actual 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 Columbia-Suicide Severity Rating Scale (C-SSRS) at the Screening Visit.
    11. Subject has an atypical Parkinson’s disease syndrome due to drugs (eg, neuroleptics, metoclopramide, flunarizine), metabolic neurogenetic disorders (eg, Wilson Disease), encephalitis, cerebrovascular disease, or degenerative diseases (progressive supranuclear palsy).
    12. Subject has a history of deep brain stimulation.
    13. Subject has a significant skin disease that would make transdermal drug use inappropriate, including a history of skin sensitivity to adhesives or transdermal medications.
    14. Subject has received electroconvulsive therapy within 12 weeks prior to the Screening Visit.
    15. Subject has evidence of an Impulse Control Disorder (ICD) according to the modified Minnesota Impulse Disorders Inventory (mMIDI) at the Screening Visit confirmed by a positive structured clinical interview.
    16. Subject has a previous diagnosis of severe restless legs syndrome.
    17. Subject has chronic migraine (>15 days per month).
    18. Subject currently has severe depression.
    19. Subject is currently lactating or pregnant or planning to become pregnant during the duration of the study.
    20. Subject has symptomatic orthostatic hypotension at the Screening Visit.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to the end of the Maintenance Period in pain severity “average pain experienced in the last 7 days” assessed by an 11-point Likert Pain Scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following titration (7 weeks) and maintainance (12 weeks) periods, 19 weeks total
    E.5.2Secondary end point(s)
    • Percentage of responders at the end of the Maintenance Period, with responders defined as “2 point reduction on an 11-point Likert Pain Scale”
    • Change from Baseline to the end of the Maintenance Period in the sum score of the 8-item Parkinson’s Disease Questionnaire (PDQ-8)
    • Change from Baseline to the end of the Maintenance Period of the 7-item depression subscore of the Hospital Anxiety and Depression Scale (HADS)
    • Change from Baseline to the end of the Maintenance Period of the 7-item anxiety subscore of the HADS
    • Change from Baseline to the end of the Maintenance Period in the combined score of the Unified Parkinson’s Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] subscale) and III (motor subscale)
    • Change from Baseline to the end of the Maintenance Period in the total score of classification of pain in Parkinson’s disease <<TBC if algorithm is available to calculate total score>>
    E.5.2.1Timepoint(s) of evaluation of this end point
    Following titration (7 weeks) and maintainance (12 weeks) periods, 19 weeks total
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Argentina
    France
    Germany
    Hungary
    Korea, Republic of
    Mexico
    Poland
    Russian Federation
    Slovakia
    Ukraine
    United Kingdom
    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 patient, last visit
    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 months5
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days20
    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: 319
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 159
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 478
    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)
    Following final visit, subjects will return to standard of care treatment as defined by their regular physician
    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 Decision2012-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-30
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