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

NCT ID: NCT01386944

Last Updated: 2018-04-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Restless Legs Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neupro® Treatment

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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12

Berlin, , Germany

Site Status

4

Bremen, , Germany

Site Status

18

Dresden, , Germany

Site Status

20

Flensburg, , Germany

Site Status

1

Kassel, , Germany

Site Status

11

Marburg, , Germany

Site Status

17

Marburg, , Germany

Site Status

2

Mönchengladbach, , Germany

Site Status

6

Münster, , Germany

Site Status

7

Regensburg, , Germany

Site Status

21

Remscheid, , Germany

Site Status

15

Schriesheim, , Germany

Site Status

10

Schwalmstadt, , Germany

Site Status

3

Schwerin, , Germany

Site Status

8

Tübingen, , Germany

Site Status

16

Ulm, , Germany

Site Status

9

Ulm, , Germany

Site Status

19

Westerstede, , Germany

Site Status

Countries

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Germany

References

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Trenkwalder C, Canelo M, Lang M, Schroeder H, Kelling D, Berkels R, Schollmayer E, Heidbrede T, Benes H. Management of augmentation of restless legs syndrome with rotigotine: a 1-year observational study. Sleep Med. 2017 Feb;30:257-265. doi: 10.1016/j.sleep.2015.10.006. Epub 2015 Nov 11.

Reference Type RESULT
PMID: 26896370 (View on PubMed)

Other Identifiers

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SP1009

Identifier Type: -

Identifier Source: org_study_id

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