A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
Restless Legs Syndrome
About this trial
This is an interventional treatment trial for Restless Legs Syndrome focused on measuring RLS, Rotigotine, Neupro
Eligibility Criteria
Inclusion Criteria:
- Subject is male or female, and is >=13 and <18 years of age at Baseline
- Subject's Restless Legs Syndrome (RLS) symptoms cause significant daytime symptoms or significant distress or impairment in social, occupational, educational, or other important areas of functioning by the impact on sleep, energy/vitality, daily activities, behavior, cognition or mood
- At Baseline, subject has a score of >=15 on the International Restless Legs Rating Scale (IRLS) (indicating moderate-to-severe RLS)
- At Baseline, subject scores >=4 points on the Clinical Global Impressions (CGI) Item 1 assessment (indicating at least moderately ill)
- If subject is receiving supplemental iron, subject has been on a stable dose for at least 3 months prior to Screening
- Female subjects must be surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of study medication.
Exclusion Criteria:
- Subject has a serum ferritin level <50 ng/mL at Visit 1/Screening
- Subject has a hemoglobin level below the lower limit of normal at Visit 1/Screening
- Subject has had previous treatment with dopamine agonists or L-dopa within 7 days prior to Visit 2/Baseline
- Subject has any medical or psychiatric condition, which in the opinion of the investigator, would jeopardize or compromise the subject's well-being or ability to participate in this study
- Subject is pregnant or nursing
- Subject is not willing to abstain from caffeine after 4 pm each evening within 7 days prior to Visit 2/Baseline and for the duration of the study
- At Visit 1/Screening, subject has symptomatic orthostatic hypotension with a decrease of blood pressure (BP) from supine to standing position of >=20 mmHg in systolic blood pressure (SBP) or of >=10 mmHg in diastolic
Sites / Locations
- Sp1006 101
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
2 milligram/24 hours rotigotine
3 milligram/24 hours rotigotine
Placebo
Subjects randomized to this arm will be initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine, which is the assigned dose level throughout the 12-week Maintenance Period.
Subjects randomized to this arm will be initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine, which is the assigned dose level throughout the 12-week Maintenance Period.
Subjects randomized to this arm will receive matching placebo patches to maintain the blinding.