Restless Leg Syndrome Clinical Trial
Official title:
Efficacy and Safety of the RESTIFFIC™ Brand Pressure Application System, the Restless Leg Relaxer to Reduce the Symptoms of Moderate to Severe Restless Leg Syndrome
The purpose of this study is to determine the safety and efficacy of RESTIFFIC™, a foot wrap that produces adjustable targeted pressure on specific muscles in the feet, to reduce the symptoms of moderate to severe primary Restless Legs Syndrome.
Restless legs syndrome (RLS), or Willis-Ekbom Disease, is a neurologic disorder causing
unpleasant sensations and an urge to move the legs when the person is at rest. The
sensations are relieved by movement. Loss of sleep associated with RLS can cause extreme
fatigue, affecting concentration, which may produce anxiety and depression, resulting in a
poor quality of life. Prevalence in the general population is 5% to 10%. In approximately
3%, symptoms are so severe that treatment is sought. Potent drugs, such as opioids, central
nervous system depressants, anticonvulsants, and dopamine agonists have been used to ease
symptoms, each with several side effects.
Anecdotal evidence suggested that pressure on specific foot muscles decreases symptoms of
moderate to severe primary restless legs syndrome. In the RESTIFFIC™ study, patients served
as their own negative controls, wearing the RESTIFFIC™ devices intermittently, while
completing surveys related to RLS throughout the study. Physicians also completed surveys
related to quality of life. Meta-analysis was used to compare RESTIFFIC™ to historic reports
of ropinirole and placebo pill. Demographics, disease severity,inclusion/exclusion criteria,
assessment tools were similar among studies.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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