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    Summary
    EudraCT Number:2011-003486-15
    Sponsor's Protocol Code Number:SP0934
    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:2012-03-19
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio multicentrico, in doppio cieco, randomizzato, controllato verso placebo, a gruppi paralleli con polisonnografia, per valutare l'efficacia e la sicurezza di rotigotina transdermica in soggetti con sindrome delle gambe senza riposo e con malattia renale allo stadio terminale che necessitano di emodialisi
    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
    Uno studio sul laboratorio del sonno per valutare la sicurezza e l'efficacia di rotigotina cerotto in soggetti con sindrome delle gambe senza riposo e Malattia renale in stadio terminale che richiedono emodialisi
    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 number49 2173 48 1515
    B.5.5Fax number49 2173 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.3.2Product code NA
    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.3.9.3Other descriptive nameNA
    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.3.2Product code NA
    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.3.9.3Other descriptive nameNA
    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.3.2Product code NA
    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.3.9.3Other descriptive nameNA
    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
    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)
    Sindrome delle gambe senza riposo in pazienti con malattia renale allo stadio terminale
    E.1.1.1Medical condition in easily understood language
    Restless Legs Syndrome in patients with End Stage Renal Disease
    (ESRD)
    Sindrome delle gambe senza riposo in pazienti con malattia renale allo stadio terminale
    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 study is to demonstrate superiority of rotigotine against placebo in subjects with RLS and ESRD requiring hemodialysis.
    l’obiettivo primario del presente studio è quello di dimostrare la superiorità della rotigotina rispetto al placebo in soggetti con sindrome delle gambe senza riposo (RLS, Restless Legs Syndrome) e insufficienza renale terminale (ESRD, End-Stage Renal Disease) che richiede l’emodialisi
    E.2.2Secondary objectives of the trial
    The secondary objectives are to investigate the pharmacodynamics of rotigotine (ie, effect on 24h blood pressure and heart rate) and its effect of rotigotine on quality of life and sleep in this patient population. In addition, safety, tolerability, and plasma concentration of rotigotine will be evaluated.
    gli obiettivi secondari consistono nella valutazione della farmacodinamica della rotigotina (ovvero l’effetto sulla pressione arteriosa e la frequenza cardiaca nelle 24 ore) e degli effetti della rotigotina sulla qualità di vita e del sonno nella popolazione di soggetti esaminata. Verranno inoltre valutate la sicurezza, la tollerabilità e la concentrazione plasmatica della rotigotina.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOKINETIC/PHARMACODYNAMIC:
    Vers:2
    Date:2011/11/18
    Title: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
    Objectives:: The following pharmacokinetic variables will be measured: Plasma concentration of unconjugated and total rotigotine; Plasma concentrations of unconjugated and total rotigotine normalized by dose and by weight; Changes from Baseline to the end of the 2-week Maintenance Period in 24h BP; Changes from Baseline to the end of the 2-week Maintenance Period in 24h Holter ECG

    FARMACOCINETICA/FARMACODINAMICA:
    Vers:2
    Data:2011/11/18
    Titolo:Studio in doppio cieco, randomizzato, controllato verso placebo, a 2 bracci, a gruppi paralleli con polisonnografia, per valutare l'efficacia e la sicurezza di rotigotina transdermica in soggetti con sindrome delle gambe senza riposo e con malattia renale allo stadio terminale che necessitano di emodialisi
    Obiettivi:verranno misurate le seguenti variabili farmacodinamiche: concentrazione plasmatica di rotigotina non coniugata e totale;concentrazioni plasmatiche di rotigotina non coniugata e totale normalizzata in base a dosaggio e peso; cambiamenti dal basale al termine del periodo di mantenimento di 2 settimane nella pressione sanguigna nelle 24 ore; cambiamenti dal basale al termine del periodo di mantenimento di 2 settimane nell’ECG Holter nelle 24 ore.

    E.3Principal inclusion criteria
    To be eligible to participate in this study, all of the following criteria must be met:
    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 study and is willing and able to comply with the study 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 study patches correctly.
    4. Subject is male or female, and is ≥18 and ≤80 years of age.
    5. Subject has a body mass index (BMI) of ≥18kg/m2 and ≤35kg/m2.
    6. Subject has ESRD requiring hemodialysis and has been on a regular dialysis schedule of 3 times per week for at least 6 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:
    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.
    Per essere idonei a partecipare al presente studio, è necessario soddisfare tutti i criteri seguenti:
    1. Il soggetto deve essere informato, deve avere abbastanza tempo e la possibilità per considerare la propria partecipazione e deve aver consegnato il proprio consenso informato scritto.
    2. Il soggetto comprende la natura investigativa dello studio ed è disposto e in grado di soddisfare i requisiti dello studio. Il soggetto è disposto ad accettare il fatto che potrebbe essere sottoposto a trattamento con placebo durante il periodo di trattamento.
    3. Il soggetto è in grado di applicare/rimuovere correttamente i cerotti per lo studio.
    4. Il soggetto è un maschio o una femmina di età ≥ 18 e ≤ 80.
    5. Il soggetto ha un indice di massa corporea (IMC) ≥ 18kg/m2 e ≤ 35kg/m2.
    6. Il soggetto è affetto da ESRD richiedente emodialisi ed è stato sottoposto a un programma di dialisi regolare di 3 volte alla settimana per almeno 6 mesi precedenti allo screening (Visita 1).
    7. Il soggetto presenta una concentrazione di emoglobina ≥ 8g/dl (4,97mmol/l) allo screening (Visita 1).
    8. Il soggetto presenta una concentrazione di ferritina ≥ 100ng/ml allo screening (Visita 1).
    9. Al soggetto è stata diagnosticata la RLS sulla base dei 4 sintomi clinici cardinali stabiliti dal Gruppo di studio della sindrome delle gambe senza riposo:
    e. bisogno irresistibile di muovere le gambe associato o causato da sensazioni spiacevoli nelle gambe (il bisogno irresistibile di movimento può essere presente anche in assenza di sensazioni spiacevoli. Possono essere interessate anche altre parti del corpo);
    f. il bisogno impellente di movimento o le sensazioni spiacevoli compaiono o peggiorano nei periodi di riposo o inattività, come quando il paziente è disteso o seduto;
    g. il bisogno impellente di movimento o le sensazioni spiacevoli vengono attenuate parzialmente o totalmente dal movimento, quali la deambulazione o lo stiramento degli arti, e il sollievo perdura almeno fino alla cessazione del movimento;
    h. il bisogno impellente di movimento o le sensazioni spiacevoli peggiorano o compaiono la sera o durante la notte (in caso di sintomatologia molto grave, il peggioramento notturno può apparire trascurabile, ma deve essere stato presente in precedenza).
    10. Il soggetto ha inizialmente risposto a un trattamento con dopaminergici per la RLS oppure non è stato mai sottoposto a trattamento a base di dopaminergici (ovvero de novo).
    11. Al basale (Visita 2), il paziente ha riportato un punteggio di ≥ 15 punti sulla scala IRLS (che indica una RLS da moderata a grave).
    12. Al basale (Visita 2), il paziente ha riportato un punteggio di ≥ 11 punti sul RLS-DI (Diagnostic Index, Indice diagnostico).
    13. Al basale (Visita 2), il paziente ha riportato un punteggio di ≥ 4 punti sulla valutazione CGI (Clinical Global Impression, Impressione clinica globale) posizione 1 (che indica patologia di grado moderato).
    14. Al basale (Visita 2), il paziente riporta un valore di ≥ 15 PLM/ore sull’indice PLMI (Periodic Limb Movements Index, Indice di movimenti limbici periodici) basato sulla PSG (registrata durante la seconda notte) o stabilito dallo sperimentatore.
    E.4Principal exclusion criteria
    1.Subject has RLS associated with previous or concomitant therapy with dopamine D2 receptor antagonists, butyrophenones, metoclopramide, atypical antipsychotics antidepressants, mianserine, or lithium or H2-blockers 2.Subject has a history of any sleep disorder other than RLS, such as sleep apnea syndrome (including obstructive sleep apnea) not treated by a controlled Continuous Positive Airway Therapy (CPAP) for at least 1 month prior to Screening (Visit 1), or 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, painful legs, and moving toes.5.Subject has other central nervous system diseases.6.Subject has evidence of an impulse control disorder according to (mMIDI).7.Subject has a lifetime history of suicide.8.Subject has a prior history of psychotic episodes.9.Subject has a history of chronic alcohol or drug abuse within the prior 12 months.
    10.Subject has any medical or psychiatric condition which in the opinion of the investigator, can jeopardize or compromise the subject’s wellbeing.11.Subject has a history of symptomatic 12.Subject has clinically relevant cardiovascular disease which, in the opinion of the investigator, can compromise the subject’s wellbeing or ability to participate in this study.
    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, hypnotics, antidepressants, anxiolytic drugs, anticonvulsive therapy, budipine, dopamine antagonist antiemetics (except domperidone), opioids, benzodiazepines (zolpidem and zopiclone may be considered as rescue medication in case of inability to sleep), monoamine oxidase (MAO) inhibitors, catechol O methyltransferase (COMT) inhibitors, sedative antihistamines, psychostimulants, or amphetamines.. 16 is pregnant, nursing, or is a woman of childbearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combined effective methods of contraception.
    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 14 days 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.
    20.Subject has received previous treatment with rotigotine.21.Subject has participated in another study of an investigational drug within the 28 days prior to Baseline.22.Subject has a known hypersensitivity to any of the components of the study medication,
    1) Il soggetto ha una RLS associata a trattamento terapeutico precedente o concomitante a base di antagonisti di recettori dopaminergici D2, butirofenoni, metoclopramide, antipsicotici atipici antidepressivi, mianserina, litio o H2-bloccanti 2.Il soggetto presenta una storia di disturbi del sonno diversi dalla RLS, come la sindrome delle apnee del sonno (compresa l’apnea ostruttiva del sonno) non trattati mediante trattamento con pressione continua positiva (CPAP, Continuous Positive Airway Therapy) per almeno un mese precedente allo screening (Visita 1), oppure se è affetto da narcolessia o altra ipersonnia (compresi attacchi di sonno/addormentamenti improvvisi) osservate durante la PSG locale, durante il test ripetuto della latenza del sonno (MSLT, Multiple Sleep Latency Test), durante il test di mantenimento della veglia (MWT, Maintenance of Wakefulness Test) o evidenziate dall’anamnesi del soggetto. 3.Il soggetto presenta una polineuropatia clinicamente rilevante o una varicosi che a detta dello sperimentatore non possono essere differenziate chiaramente dalla sintomatologia della RLS. 4.Il soggetto è affetto da patologie concomitanti clinicamente rilevanti, quali il disturbo da deficit d’attenzione e iperattività, gambe doloranti e dita dei piedi irrequiete.5.Il soggetto ha altre patologie del sistema nervoso centrale.6.Il soggetto presenta sintomi di un disturbo del controllo degli impulsi in base alla (mMIDI)).7.Il soggetto presenta una lunga storia di tentati suicidi. 8.Il soggetto presenta una storia pregressa di episodi psicotici.9.Il soggetto ha una storia di alcolismo cronico o di abuso di droghe negli ultimi 12 mesi.10.Il soggetto è affetto da una malattia medica o psichiatrica che secondo lo sperimentatore potrebbe mettere a rischio o compromettere il benessere del soggetto 11.Il soggetto ha una storia di ipotensione ortostatica sintomatica
    12.Il soggetto ha una patologia cardiovascolare clinicamente rilevante che secondo lo sperimentatore potrebbe mettere a rischio o compromettere il benessere del soggetto e la sua capacità di partecipazione allo studio. 13Il soggetto è affetto da malattia vascolare periferica arteriosa o venosa clinicamente rilevante.
    14.Il soggetto presenta una patologia neoplastica maligna che ha richiesto trattamenti terapeutici nei 12 mesi precedenti lo screening (Visita 1).15.Il soggetto è attualmente sottoposto a trattamento con una delle seguenti classi farmacologiche: neurolettici, ipnotici, antidepressivi, farmaci ansiolitici, terapia anticonvulsiva, budipina, antagonistici dopaminergici antiemetici (tranne domperidone), oppioidi, benzodiazepine (zolpidem e zopiclone possono essere considerati farmaci di emergenza in caso di insonnia), inibitori delle monoamminossidasi (MAO), inibitori della catecol-O-metiltrasferasi (COMT), antistaminici sedativi, psicostimolanti o anfetamine16.Il soggetto è gravido, in allattamento o è una donna potenzialmente fertile non sterilizzata chirurgicamente, nei due anni postmenopausa o che non impiega in modo coerente due metodi contraccettivi efficaci in combinazione.17.Il soggetto lavora in turni o abbia altre condizioni perduranti non patologiche che non permettano il sonno regolare durante la notte.18.Il soggetto è stato sottoposto a un trattamento a base di agonisti dopaminergici in un periodo di 14 giorni precedenti il basale (Visita 2), o di L-dopa nei 7 giorni precedenti il basale (Visita 2).
    19.Il soggetto ha un’anamnesi clinica che evidenzia intolleranza alla terapia dopaminergica.20.Il soggetto è già stato trattato in precedenza con rotigotina.21.Il soggetto ha partecipato a un altro studio farmacologico sperimentale nei 28 giorni precedenti il basale.22.Il soggetto ha un’ipersensibilità nota verso uno dei componenti del farmaco oggetto dello studio,
    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
    riduzione dell’indice di movimenti limbici periodici (PLMI) al termine del periodo di mantenimento rispetto al basale, paragonando il rapporto dal basale fino al termine del periodo di mantenimento di 2 settimane nel PLMI (movimenti limbici periodici [PLM]/tempo totale a letto), come misurato tramite PSG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to the end of the 2-week Maintenance period
    Baseline al termine delle due settimane del periodo di mantenimento
    E.5.2Secondary end point(s)
    -PLMI (PLMs/total time in bed);
    -International Restless Legs Syndrome Study Group Rating Scale (IRLS) sum score;
    -Clinical Global Impressions (CGI) Item 1 score;
    -Individual RLS-6 Rating Scales (RLS-6) score;
    -Periodic Limb Movement during Sleep Arousal Index (PLMSAI);
    -Sleep efficiency (%);
    -RLS-QoL;
    -SF-3
    -PLMI (PLM/tempo totale a letto),
    -punteggio complessivo in base alla scala di valutazione International Restless Legs Syndrome Study Group Rating Scale (IRLS),
    -punteggio Clinical Global Impressions (CGI) posizione 1,
    -punteggio scale di valutazione RLS-6 individuale (RLS-6),
    -indice del movimento limbico periodico durante microrisvegli nel sonno (PLMSAI, Periodic Limb Movement during Sleep Arousal Index),
    -efficacia del sonno (%),
    -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
    Le variabili secondarie saranno misurate come variazione dal basale al termine del periodo di 2 settimane di mantenimento
    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 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 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 concerned3
    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
    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
    LVLS
    LVLS
    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 months13
    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 months13
    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.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
    Si prega di fare riferimento alle seguenti sezioni del protocollo: - 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 Decision2012-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-29
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