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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01386944
First received: June 29, 2011
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

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.


Condition
Restless Legs Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non Interventional Observational Study to Collect Data for the Effect of Switching to Neupro® on Severity of Restless Leg Syndrome (RLS) Symptoms and Augmentation as Well as the Change in Treatment Regimen Used, in RLS Patients With Previous Augmentation

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Change from baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - severity of illness) to Visit 2 [ Time Frame: From baseline up to 7 days ] [ Designated as safety issue: No ]
  • Change from baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - severity of illness) to Visit 3 [ Time Frame: From baseline up to 28 days ] [ Designated as safety issue: No ]
  • Change from baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - severity of illness) to Visit 4 [ Time Frame: From baseline up to 4 months ] [ Designated as safety issue: No ]
  • Change from baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - severity of illness) to Visit 5 [ Time Frame: From baseline up to 7 months ] [ Designated as safety issue: No ]
  • Change from baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - severity of illness) to Visit 6 [ Time Frame: From baseline up to 10 months ] [ Designated as safety issue: No ]
  • Change from baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - severity of illness) to Visit 7 [ Time Frame: From baseline up to 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in treatment regimen used for switching to Neupro® up to 28 days after entering in the study [ Time Frame: From baseline up to 28 days ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: July 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Neupro® Treatment
Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patient with a diagnosis of moderate to severe idiopathic Restless Leg Syndrome (RLS).

Patient must be experiencing augmentation due to a prior dopaminergic treatment.

Every consecutive, eligible patient to be treated with Neupro® as per physician's decision.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386944

Locations
Germany
12
Berlin, Germany
4
Bremen, Germany
18
Dresden, Germany
20
Flensburg, Germany
1
Kassel, Germany
11
Marburg, Germany
17
Marburg, Germany
2
Mönchengladbach, Germany
6
Münster, Germany
7
Regensburg, Germany
21
Remscheid, Germany
15
Schriesheim, Germany
10
Schwalmstadt, Germany
3
Schwerin, Germany
8
Tuebingen, Germany
9
Ulm, Germany
16
Ulm, Germany
19
Westerstede, Germany
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01386944     History of Changes
Other Study ID Numbers: SP1009
Study First Received: June 29, 2011
Last Updated: September 2, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:
Rotigotine
Neupro®
Augmentation
Restless Legs Syndrome
Moderate to severe
idiopathic
adults

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014