Overview

Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects

Status:
Completed

Trial end date:
2007-09-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

UCB Pharma

Treatments:

N 0437
Rotigotine

Criteria

Inclusion Criteria:

- Subject completed the Maintenance Period and Taper Period of SP790 or SP794

Exclusion Criteria:

- Subject has an ongoing serious adverse event (SAE) from SP790 or SP794 that is
assessed to be related to the trial medication by the investigator and/or the sponsor.

- Subject has any medical or psychiatric condition that, in the opinion of the
investigator, can jeopardize or would compromise the subject's ability to participate
in this trial