Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation (AURORA)
This study is ongoing, but not recruiting participants.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01386944
First received: June 29, 2011
Last updated: April 25, 2013
Last verified: April 2013
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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:
MedlinePlus related topics:
Restless Legs
Drug Information available for:
Rotigotine
U.S. FDA Resources
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 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 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
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: | April 25, 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 May 16, 2013