Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome

Inclusion Criteria:

- Subject or parent/legal representative is considered reliable and capable of adhering
to the protocol

- Subject is male or female, and is ≥13 and <18 years of age at Visit 2/Baseline

- Subject weighs ≥40 kg at Visit 2/Baseline

- Subject's Body Mass Index (BMI) is less than the 95th percentile for his or her age at
Visit 2/Baseline

- Subject meets the diagnosis of RLS based on the proposed 2011 Revised International
Restless Legs Syndrome Study Group Diagnostic Criteria

- Subject's RLS symptoms cause significant distress or impairment

- At Visit 2/Baseline, subject has a Periodic Limb Movement Index (PLMI) ≥5 during at
least 1 of the 5 nights prior to Baseline as measured by the activity monitors

- At Visit 2/Baseline, subject has a score of ≥15 on the IRLS Rating Scale

- At Visit 2/Baseline, subject scores ≥4 points on the Clinical Global Impression (CGI)
Item 1 assessment

- Subject receiving supplemental iron has been on a stable dose for at least 3 months
prior to Visit 1/Screening Period

Exclusion Criteria:

- Previously participated in this study or received previous treatment with rotigotine

- Participated in another study of an investigational medicinal product (IMP) or a
medical device within the last 3 months prior to Visit 1/Screening Period or is
currently participating in another study of an IMP or a medical device

- Subject's RLS symptoms are restricted only to the ankles or knees

- RLS symptoms are due to renal insufficiency (uremia) or iron deficiency anemia

- Previous treatment with dopamine agonists within a period of 14 days prior to Visit
2/Baseline or L-dopa within 7 days prior to Visit 2/Baseline

- Failed to respond to previous dopaminergic therapy

- 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

- Subject has a lifetime history of suicide attempt or has suicidal ideation in the past
6 months

- Evidence of an impulse control disorder (ICD)

- History or current symptoms of sleep apnea, narcolepsy, sleep attacks/sudden onset of
sleep, or myoclonus epilepsy

- Concomitant diseases such as peripheral neuropathy, muscle fasciculation, painful legs
and moving toes, fibromyalgia, rheumatoid arthritis, or sickle cell disease

- Serum ferritin level <15 ng/mL

- Subject has not attempted at least 1 non-pharmacological intervention for the
management of RLS (eg, sleep hygiene, exercise)

- Prior history of psychotic episodes

- History of chronic alcohol or drug abuse within 12 months prior Screening Period

- Clinically relevant cardiac dysfunction and/or arrhythmias

- Hemoglobin level below the lower limit of normal

- Clinically relevant renal dysfunction (serum creatinine >1.5 mg/dL)

- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin
level greater than or equal to 2 times the upper limit of normal

- History or presence of clinical signs of any malignant neoplasm including suspicious
undiagnosed skin lesion (which may be melanoma), melanoma, or a history of melanoma

- Currently receiving or has received treatment with any of the following within 28 days
prior to Visit 2/Baseline: neuroleptics, antidepressants, anxiolytic drugs, opioids,
monoamine oxidase (MAO) inhibitors, or sedative antihistamines

- Currently receiving treatment with any of the following: benzodiazepines, hypnotics,
anticonvulsants, central alpha-adrenergic agonists, or melatonin; unless treatment is
for RLS only, in which case a Wash-Out Period of at least 14 days prior to Visit
2/Baseline is required

- Currently receiving stimulant therapy for attention deficit hyperactivity disorder
(ADHD); a Wash-Out Period of at least 7 days prior to Visit 2/Baseline is required

- Pregnant, nursing, or is a woman of childbearing potential who is not surgically
sterile, or does not consistently use 2 combined medically acceptable methods of
contraception (including at least 1 barrier method), unless not sexually active

- Unwilling to abstain from caffeine after 4pm each evening within 7 days prior to Visit
2/Baseline and for the duration of the study

- Pursues shift work or performs other continuous non-disease-related life conditions,
which do not allow regular sleep at night

- Subject has a QT correction (QTc) interval of ≥500 ms at Visit 1/Screening Period or
Visit 2/Baseline. Bazett's correction method must be used for the correction of the QT
interval

- 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 blood pressure (DBP) taken from the 5 minute supine and 1 and/or 3 minute
standing measurements

- A known hypersensitivity to any of the components of the study medication, such as a
history of significant skin hypersensitivity to adhesives, known hypersensitive