Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: N 0437; Rotigotine

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)