| Study summary: |
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Childhood RLS is estimated to affect almost 1 million school-age children, with one-third having moderate to severe symptoms. It affects about 2% of the pediatric population today.
Only a few medications have been studied in a rather limited number of children and adolescents, leaving many unanswered questions for researchers and physicians. No approved treatment for RLS in children/adolescents exists. More data is needed to advance the understanding and treatment of RLS in children and adolescents.
By enrolling in the study, you will help researchers evaluate how to assess the safety and efficacy of rotigotine to lessen moderate-to-severe RLS symptoms in adolescents. What we learn from this study and your participation may also help to determine the safest and most effective dose of study medication.
Although there is no guarantee that rotigotine will benefit participants directly or help relieve RLS symptoms, every participant's safety and comfort are our top priorities.
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| Qualified participants must: |
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• Be at least 13 years of age and younger than 18 years old (participants may turn 18 during the study)
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Weigh at least 88 pounds
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Have RLS symptoms that cause significant distress or impairment in social, occupational, academic, or other important areas of functioning by its impact on sleep, mood, cognition, health, daily activities, or energy/vitality
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| Participants may receive: |
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Visits with the doctor each week for a period of approximately 13 weeks. During these visits, you will receive your study medication and be asked to complete questionnaires about your RLS symptoms and other study related topics. The study doctor will also perform tests and procedures that may include vital signs, an ECG, and urine and blood samples. |