Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation (AURORA)

UCB

Status: Completed

Conditions: Restless Legs Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT01386944

SP1009

Details and patient eligibility

About

The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome (RLS) symptoms and augmentation in patients with augmentation associated with previous oral dopaminergic therapy. In addition, the change in treatment regimen used when switching to Neupro® will be evaluated.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The adult patient has a diagnosis of moderate to severe idiopathic Restless Leg Syndrome (RLS)
• The patient must be experiencing augmentation due to a prior dopaminergic treatment
• The decision to prescribe Neupro® has been made by the physician independently of his/her decision to enroll the patient in the study
• Patient is informed and given ample time and opportunity to think about his/her participation in the study and has given written informed data consent

Exclusion criteria

• Patients diagnosed with secondary Restless Leg Syndrome (RLS) should not be enrolled in this observational study

Trial design

102 participants in 1 patient group

Neupro® Treatment

Description:

Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).