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Clinical Trial Summary

This is a multicenter, open-label trial to assess safety and tolerability of rotigotine in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year in subjects who previously participated in SP790 (6-month pivotal trial) or SP794 (sleep lab trial). Subjects who successfully completed the Maintenance Period and the Taper Period of SP790 or SP794 are allowed to enroll in this trial.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00498108
Study type Interventional
Source UCB Pharma
Contact
Status Completed
Phase Phase 3
Start date January 2006
Completion date September 2007

See also
  Status Clinical Trial Phase
Completed NCT00390689 - A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS. Phase 3
Completed NCT01113710 - Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise N/A
Completed NCT00666965 - A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients Phase 2
Completed NCT01084551 - Study of SPM 962 in Patients With Restless Legs Syndrome (RLS) Phase 3
Completed NCT00806026 - Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients Phase 3
Completed NCT01562743 - A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome Phase 2