| Participants |
Male and female patients aged 18 to 85 years Inclusion criteria: ESKD requiring haemodialysis. Diagnosis of RLS based on the 4 cardinal diagnostic clinical features according to the IRLSSG. Initial response to previous dopaminergic treatment for RLS, or has had no previous dopaminergic treatment (ie, de novo). Score of ≥ 15 points on the IRLS (indicating moderate to severe RLS) at baseline score of ≥ 11 points on the RLS‐Diagnostic Index at baseline score of ≥ 4 points on the CGI Item 1 assessment (indicating moderately ill) at baseline. Scores ≥ 15 PLM/h on the PLMI based on polysomnography (recorded during the second night) as assessed by the investigator at Baseline.
Exclusion criteria: clinically relevant polyneuropathy or varicosis which cannot be clearly differentiated from RLS symptoms in the opinion of the investigator; clinically relevant concomitant diseases; other central nervous system diseases; evidence of an impulse control disorder according to the modified Minnesota Impulsive Disorders Interview; lifetime history of suicide attempt, or has suicidal ideation in the past 6 months; prior history of psychotic episodes; history of symptomatic (not asymptomatic) orthostatic hypotension; clinically relevant CVD; clinically relevant venous or arterial peripheral vascular disease malignant neoplastic disease requiring therapy within 12 months of visit 1; treatment with any of the following drug classes: neuroleptics, norepinephrine and dopamine reuptake inhibitors, gabapentin, budipine, dopamine antagonist antiemetics (except domperidone), opioids, monoamine oxidase (MAO) inhibitors, catechol‑O‑methyltransferase inhibitors, or psychostimulants; pregnancy, nursing, childbearing potential who is not surgically sterile, 2 years postmenopausal, or does not use 2 combined effective methods of contraception; previous treatment with dopamine agonists within a period of 14 days prior to baseline, or L‐dopa within 7 days prior to baseline; medical history indicating intolerability to dopaminergic therapy (if pretreated) or has experienced augmentation when previously treated with any dopaminergic agent; subject has received previous treatment with rotigotine; known hypersensitivity to any of the components of the study medication, such as a history of significant skin hypersensitivity to adhesives, known hypersensitivity to other transdermal medications, or unresolved contact dermatitis
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