long-term open-label trial in idiopathic restless legs syndrome (rls)

Conditions: Restless Legs Syndrome

Summary: this is a multi-center, open-label extension trial conducted at the same european sites that participated in trial sp 709 (nct00243217). the trial is designed to collect long-term safety and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic restless leg syndrome (rls). the duration of treatment is approximately 5 years. subject will be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses and patch sizes).


Eligibility criteria:
inclusion criteria: * subject has completed the preceding trial sp709 (nct00243217) exclusion criteria: * subject did suffer from a serious adverse event during trial sp709 (nct00243217) which is ongoing at the end of that trial and is assessed to be related to the study medication by the investigator and/or the sponsor * sleep disturbances * further clinically relevant concomitant diseases such as polyneuropathy, akathisia, claudication, varicosis, muscle fasciculation, painful legs and moving toes, or radiculopathy * other central nervous diseases * one psychotic episode since start of study sp709 * any medical or psychiatric condition, which in the opinion of the investigator can jeopardize or would compromise the subject's ability to participate in this trial * clinically relevant cardiac dysfunction and arrhythmias * the subject has at entry in study sp710, a qtc interval ≥ 500 msec and/or a qtc interval which has increased by ≥ 60 msec as compared to the average baseline (visit 2) qtc interval of study sp709 * subject has clinically relevant renal dysfunction (serum creatine ≥ 2.0 mg/dl) * subject has clinically relevant hepatic dysfunction (total bilirubin \> 2.0 mg/dl or alt and/or ast greater than two times the upper limit of the reference range * subject has a newly diagnosed or relapsing neoplastic disease since the start of study sp709 * subject has a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol * subject needs drugs prohibited in the course of this trial: neuroleptics, bupidine, hypnotics, antidepressants, anxiolytic drugs, anticonvulsive therapy, psychostimulatory drugs, other l-dopa or dopamine agonist therapy, opioids, benzodiazepines, mao inhibitors, sedative antihistamines, amphetamines * subject is abusing alcohol or drug since start of sp709 * subject is pregnant or nursing or woman of child-bearing potential who is not surgically sterile, two years postmenopausal, or does not practice two combined methods of contraception, unless sexually abstinent * subject pursues shift work or is subject to other continuous non-disease-related life conditions which do not allow regular sleep at night * subject has clinically relevant vasculopathies (eg, varix or arteriosclerosis) * subject has significant skin hypersensitivity to adhesive or other transdermals or recent unresolved contact dermatitis * subject has symptomatic orthostatic hypotension, or a systolic blood pressure (sbp) less tham 105mmhg and/or a drop in sbp of \> 20mmhg or a drop of \> 10mmhg in diastolic bp (dbp) on standing at baseline visit (visit 1)

Keywords: rotigotine neupro®