Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–79
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
provided written informed consent.
Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.
Sleep efficiency \<85% OR Latency to persistent sleep \>20 minutes.
You may not be if
Secondary RLS
Primary sleep disorder
Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
Use of any prohibited medication.
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