dose escalating study of rotigotine in pediatric subjects with restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: this was a multicenter, open-label, dose-escalation, phase 2a study with multiple administrations of the rotigotine transdermal system. the study was conducted in adolescent subjects (13 to \<18 years of age) with idiopathic restless legs syndrome (rls).


Eligibility criteria:
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

Keywords: rotigotine restless legs syndrome rls children adolescents