At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of idiopathic RLS meeting 4 essential International RLS Study Group clinical features (urge to move legs with uncomfortable sensations, symptoms worse at rest, relieved by movement, worse at night)
- ✓RLS-Diagnostic Index score ≥11
- ✓IRLS score ≥15 at baseline (moderate to severe RLS)
- ✓CGI-1 score ≥4 at baseline (moderately ill)
- ✕RLS secondary to renal insufficiency (uremia), iron deficiency anemia, or rheumatoid arthritis
- ✕RLS associated with dopamine D2 receptor antagonists, butyrophenones, metoclopramide, atypical antipsychotics, tri-/tetra-cyclic antidepressants, mianserine, lithium, H2-blockers, or withdrawal from anticonvulsants, benzodiazepines, barbiturates, or other hypnotics
- ✕History of sleep apnea syndrome, narcolepsy, sleep attacks/sudden onset of sleep, or myoclonus epilepsy on PSG or by history
- ✕Uncontrolled hypertension per investigator judgment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Double-Blind, Placebo-Controlled, Two-Arm, Randomized, Parallel, Treatment Intervention, Sleep Lab Phase 4 Study to Assess the Effect of Rotigotine on Nocturnal Blood Pressure in Patients With Idiopathic Restless Legs Syndrome
In Brief
A Phase 4 clinical trial evaluating Rotigotine and Placebo for Restless Legs Syndrome. Completed, enrolled 81 participants across 6 sites.
Detailed Summary
Periodic Limb Movements (PLMs) during sleep in patients with Restless Legs Syndrome (RLS) have been shown to be associated with elevations in Blood Pressure (BP). Rotigotine has been shown to effectively reduce the incidence of PLMs in patients with RLS. The current study aims to demonstrate that treatment with Rotigotine could help reduce the number of nocturnal BP elevations associated with PLMs in patients with RLS.
Study Details
Timeline
Interventions
Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.
Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.