Restless Legs Syndrome (RLS) MedDRA version: 14.1 Level: PT Classification code 10058920 Term: Restless legs syndrome System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: NEUPRO 1mg/24h, transdermal patch
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: ROTIGOTINE
CAS Number: 99755-59-6
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
UCB Biosciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is informed and given ample time and opportunity to think about her/his participation and give 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 patch correctly. 4. Subject is male or female, and is =18 and =75 years of age. 5. Subject meets the diagnosis of idiopathic RLS based on the 4 essential clinical features according to the International Restless Legs Syndrome Study Group (Allen et al, 2003): 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.) 6. Subject has a score of =11 on the RLS-Diagnostic Index (RLS-DI) (Benes and Kohnen, 2009). 7. Subject has an initial response to previous dopaminergic treatment for RLS or has no previous dopaminergic treatment (ie, de novo). 8. The subject’s body mass index (BMI) is =18kg/m2 and =35kg/m2. 9. At Baseline (Visit 2), subject has a score of =15 on the IRLS (indicating moderate to severe RLS). 10. At Baseline (Visit 2), subject has a score of =4 points on the CGI Item 1 assessment (indicating moderately ill). 11. At Baseline (Visit 2), subject has a score of =15 PLM/h on the PLMI based on polysomnography (PSG) (recorded during the second night) as assessed by the investigator. 12. Subjects are on a concomitant dose of antihypertensives that is at a stable dose for at least 4 weeks prior to Baseline (Visit 2) and hypertension is reasonably controlled while the subject agrees to continue at this dose for the duration of the study, or subject has not received concomitant treatment with antihypertensives for at least 4 weeks prior to Baseline (Visit 2) and does not intend to start such use during the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 47 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Subject has RLS due to renal insufficiency (uremia), iron deficiency anemia, or rheumatoid arthritis. 2. Subject has RLS associated with previous or concomitant therapy with dopamine D2 receptor antagonists, butyrophenones, metoclopramide, atypical antipsychotics (eg, olanzapine), tri- and tetra-cyclic antidepressants, mianserine, or lithium or H2-blockers (eg, cimetidine), or due to withdrawal from drugs such as anticonvulsants, benzodiazepines, barbiturates, and other hypnotics. 3. Subject has a history of sleep disturbances, such as sleep apnea syndrome (including obstructive sleep apnea), narcolepsy, sleep attacks/sudden onset of sleep, or myoclonus epilepsy either observed during PSG (local PSG evaluations) or evidenced by subject history. 4. Subject has uncontrolled hypertension according to the judgment of the investigator. 5. Subject has additional clinically relevant concomitant diseases, such as attention deficit hyperactivity disorder, polyneuropathy, akathisia, claudication, varicosis, muscle fasciculation, painful legs and moving toes, or radiculopathy. 6. 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. 7. Subject has a prior history of psychotic episodes. 8. Subject has a history of chronic alcohol or drug abuse within the previous 12 months. 9. Subject has any medical or psychiatric condition, which in the opinion of the investigator, can jeopardize or would compromise the subject’s ability to participate in this study. 10. Subject has clinically relevant cardiac dysfunction and/or arrhythmias (eg, suspected conduction system dysregulations, second or third degree atrioventricular block, complete left or right bundle branch block, sick sinus syndrome, New York Heart Association Class III or IV congestive heart failure, or had a myocardial infarction within 12 months prior to Screening [Visit 1]). 11. Subject has clinically relevant venous or arterial peripheral vascular disease. 12. Subject has a malignant neoplastic disease requiring therapy within 12 months prior to Screening (Visit 1). 13. 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, monoamine oxidase (MAO) inhibitors, catechol-O-methyltransferase (COMT) inhibitors, sedative antihistamines, psychostimulates, or 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. 14. Subject 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, including at least 1 barrier method, unless sexually abstinent. 15. Subject is a shift worker or performs other continuous non–disease-related life conditions which do not allow regular sleep at night. 16. At Screening Visit (Visit 1) or Baseline Visit (Visit 2), subject has symptomatic orthostatic hypotension with a decrease of BP from supine to standing position of =20mmHg in systolic BP or of =10mmHg in diastolic BP taken from the 5-minute supine and 1- and/or 3-m
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from Baseline in the total number of elevations of systolic BP during the night • Change from Baseline in the Periodic Limb Movements Index (PLMI) • Change from Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) • Change from Baseline in RLS-QoL • Clinical Global Impressions (CGI) Item 2 (change of condition) • Clinical Global Impressions Item 1 (severity of illness) • Clinical Global Impressions Item 3 (therapeutic efficacy) • Change from Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) ;Timepoint(s) of evaluation of this end point: end of the 4-week Maintenance Period | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate that rotigotine decreases the number of elevations of nocturnal Blood Pressure (BP) associated with Periodic Limb Movements (PLMs) in patients with idiopathic Restless Legs Syndrome (RLS).;Secondary Objective: The secondary objectives are to examine effects of rotigotine on the total number of elevations of nocturnal BP, on standard measures of cardiovascular risk surrogate markers, on standard RLS measures of disease severity, and on quality of life (QoL) measurements.;Primary end point(s): Change from Baseline in the number of elevations of systolic BP during the night that are associated with Periodic Limb Movements;Timepoint(s) of evaluation of this end point: end of the 4-week Maintenance Period | — |
Countries
Germany
Contacts
Public ContactCT Registries + Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed