Restless Leg's Syndrome MedDRA version: 7.0 Level: LLT Classification code 10058920
Conditions
Interventions
Product Name: Rotigotine
Product Code: SPM 936
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: [99755-59-6]
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Schwarz 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 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 patch correctly and consistently. 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 IRLSSG (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 had an initial response to previous dopaminergic treatment for RLS or has had no previous dopaminergic treatment (ie, de novo). 7. The subject’s body mass index (BMI) is =18kg/m2 and =35kg/m2. 8. At Baseline (Visit 2), subject has a score of =15 on the IRLS Rating Scale (indicating moderate to severe RLS). 9. At Baseline (Visit 2), subject scores =4 points on the CGI Item 1 assessment (indicating mildly ill). 10. At Baseline (Visit 2), subject scores =15 PLM/h on the PLMI based on PSG (recorded during the second night) as assessed by the investigator. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has secondary RLS (eg, due to renal insufficiency [uremia], iron deficiency anemia, or rheumatoid arthritis). 2. Subject has secondary RLS associated with previous or concomitant therapy with dopamine D2 receptor antagonists, butyrophenones, metoclopramide, atypical antipsychotics (eg, olanzapine), tri- and tetra-cyclic antidepressants, mianserine, 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 like 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 additional clinically relevant concomitant diseases such as attention deficit hyperactivity disorder, polyneuropathy, akathisia, claudication, varicosis, muscle fasciculation, painful legs and moving toes, or radiculopathy. 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 a prior history of psychotic episodes. 7. Subject has a history of chronic alcohol or drug abuse within the last 12 months. 8. 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 trial. 9. Subject has clinically relevant cardiac dysfunction and/or arrhythmias (eg, suspected conduction system dysregulations, second or third degree AV block, complete left or right bundle branch block, sick-sinus-syndrome, New York Heart Association Class III or IV congestive heart failure, or has had a myocardial infarction within 12 months prior to Screening [Visit 1]). 10. Subject has clinically relevant venous or arterial peripheral vascular disease. 11. Subject has clinically relevant renal dysfunction (serum creatinine >2.0mg/dL). 12. Subject has clinically relevant hepatic dysfunction (total bilirubin >2.0mg/dL or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 2 times the upper limit of the reference range). 13. Subject has a malignant neoplastic disease requiring therapy within 12 months prior to Screening (Visit 1). 14. Subject is currently receiving treatment with any of the following drug classes: neuroleptics, hypnotics, antidepressants, anxiolytic drugs, anticonvulsive therapy, budipine, dopamine antagonist anti-emetics (except domperidone), opioids, benzodiazepines, monoamine oxidase (MAO) inhibitors, catechol-O-methyl-transferase (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 trial. 15. 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. 16. Subject pursues shift work or performs other continuous non-disease-related life conditions which do not allow regular sleep at night. 17. At Screening (Visit 1), subject has a QT interval in ECG, corrected for heart rate (QTc), in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to demonstrate that rotigotine is effective in subjects with idiopathic RLS based on the PLMI (PLMs/total time in bed) as measured by PSG;Secondary Objective: ;Primary end point(s): Primary variable: The primary variable is the reduction of PLMI at the end of the Maintenance Period compared to Baseline. PLMI data will be obtained from PSGs. | — |
Countries
Austria, Finland, Germany, Italy, Spain
Outcome results
None listed