Restless Legs SyndromeAURORANCT01386944

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

An observational study of Restless Legs Syndrome, run by UCB Pharma at 18 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Restless Legs Syndrome
How many people: 102 participants
Where: 18 sitesGermany
Study dates: Jul 2011to Aug 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

Germany18 sites

12
Berlin
4
Bremen
18
Dresden
20
Flensburg
1
Kassel
11
Marburg
17
Marburg
2
Mönchengladbach
6
Münster
7
Regensburg
21
Remscheid
15
Schriesheim
10
Schwalmstadt
3
Schwerin
8
Tübingen
16
Ulm
9
Ulm
19
Westerstede

Other trials in Germany

About this study

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

Conditions: Restless Legs Syndrome
Keywords: Rotigotine, Neupro®, Augmentation, Restless Legs Syndrome, Moderate to severe, idiopathic, adults
Medical subject headings: Restless Legs Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01386944
Study group	Role	What they receive
Neupro® Treatment		Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
1. = Normal, not ill at all
2. = Borderline ill
3. = Mildly ill
4. = Moderately ill
5. = Markedly ill
6. = Severely ill
7. = Among the most extremely ill subjects
A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1.
Measured: From Baseline up to 7 days
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
1. = Normal, not ill at all
2. = Borderline ill
3. = Mildly ill
4. = Moderately ill
5. = Markedly ill
6. = Severely ill
7. = Among the most extremely ill subjects
A negative change from Baseline to Visit 3 indicates an improvement in CGI Item 1.
Measured: From Baseline up to 28 days
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
1. = Normal, not ill at all
2. = Borderline ill
3. = Mildly ill
4. = Moderately ill
5. = Markedly ill
6. = Severely ill
7. = Among the most extremely ill subjects
A negative change from Baseline to Visit 4 indicates an improvement in CGI Item 1.
Measured: From Baseline up to 4 months
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
1. = Normal, not ill at all
2. = Borderline ill
3. = Mildly ill
4. = Moderately ill
5. = Markedly ill
6. = Severely ill
7. = Among the most extremely ill subjects
A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1.
Measured: From Baseline up to 7 months
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
1. = Normal, not ill at all
2. = Borderline ill
3. = Mildly ill
4. = Moderately ill
5. = Markedly ill
6. = Severely ill
7. = Among the most extremely ill subjects
A negative change from Baseline to Visit 6 indicates an improvement in CGI Item 1.
Measured: From Baseline up to 10 months
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
1. = Normal, not ill at all
2. = Borderline ill
3. = Mildly ill
4. = Moderately ill
5. = Markedly ill
6. = Severely ill
7. = Among the most extremely ill subjects
A negative change from Baseline to Visit 7 indicates an improvement in CGI Item 1.
Measured: From Baseline up to 13 months

Secondary outcomes (1)

Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study
Case reports from clinical practice refer to different switching regimens for patients taking oral dopaminergics who experienced augmentation and then switched to Neupro®. The previous dopaminergic treatment might have been partly or completely down-titrated prior to switching to Neupro®. Physicians were requested to document the change of treatment at each recommended visit in the electronic Case Report Form (eCRF) considering their total clinical experience with this particular Restless Legs Syndrome (RLS) patients population. Documentation comprised changes in the RLS medication last prescribed, and the dosage of Neupro® and concomitant medications. The change of treatment regimen was entirely at the physicians' discretion.
Measured: From Baseline up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Aug 2013

First posted1 Jul 2011 (estimated)
Study startJul 2011
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01386944
Sponsor's protocol ID: SP1009
Acronym: AURORA
Status last verified: Mar 2018
First submitted: 29 Jun 2011
Last updated: 4 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26896370

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01386944
Acronym / sponsor ID: AURORA / SP1009
Conditions: Restless Legs Syndrome
Keywords: Rotigotine, Neupro®, Augmentation, Restless Legs Syndrome, Moderate to severe, idiopathic, adults
Study type: Observational
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 1 Jul 2011 (estimated)
Results: Posted 15 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Neupro® Treatment	–	–Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: 1. = Normal, not ill at all 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1.
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
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: 1. = Normal, not ill at all 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects A negative change from Baseline to Visit 3 indicates an improvement in CGI Item 1.
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
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: 1. = Normal, not ill at all 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects A negative change from Baseline to Visit 4 indicates an improvement in CGI Item 1.
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
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: 1. = Normal, not ill at all 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1.
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
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: 1. = Normal, not ill at all 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects A negative change from Baseline to Visit 6 indicates an improvement in CGI Item 1.
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
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: 1. = Normal, not ill at all 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects A negative change from Baseline to Visit 7 indicates an improvement in CGI Item 1.

1 secondary outcome

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

Results and safety

Results posted to the registry on 15 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Neupro® Treatment	102	46

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	Neupro® Treatment n = 89
Value	-0.8 (1.1)

Neupro® Treatment: Hodges-Lehmann Estimate: -0.5 (95% CI -1.0 to -0.5)

Population analysed: The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	Neupro® Treatment n = 77
Value	-1.4 (1.3)

Neupro® Treatment: Hodges-Lehmann Estimate: -1.5 (95% CI -1.5 to -1.0)

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	Neupro® Treatment n = 58
Value	-1.8 (1.2)

Neupro® Treatment: Hodges-Lehmann Estimate: -2.0 (95% CI -2.0 to -1.5)

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	Neupro® Treatment n = 52
Value	-2.0 (1.4)

Neupro® Treatment: Hodges-Lehmann Estimate: -2.0 (95% CI -2.5 to -1.5)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events were reported from Day 1 up to 13 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neupro® Treatment	9 of 99 (9.1%)	40 of 99 (40.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26896370Trenkwalder 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Restless Legs Syndrome, run by UCB Pharma at 18 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01386944, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.