Idiopathic Restless Legs SyndromeRLS-PractiseNCT01113710
Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise
An observational study of Idiopathic Restless Legs Syndrome, run by UCB Pharma at 80 sites in Germany.
Trial summary
This non-interventional observational study is designed to gain data for Neupro® in restless legs syndrome (RLS) under real life conditions in line with the summary of product characteristics (SmPC) related to effectiveness, tolerability and switching practice from other dopaminergic drugs as well as titration schemes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Restless Legs Syndrome
- What is being tested?
- Neupro®
- How many people
- 687 participants
- Where
- 80 sitesGermany
- Study dates
- May 2010to Jul 2011
- 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 patients with a diagnosis of moderate to severe idiopathic RLS treated with Neupro® in routine daily practice.
Who may be able to join
- It was recommended that the patient's treatment was in accordance with the local marketing authorization (MA) for Neupro®
- The patient must have a diagnosis of moderate to severe idiopathic RLS
- The patient is considered reliable and capable of adhering to the visit schedule or medication administration according to the judgment of the investigator
- The decision to prescribe the drug has been made by the physician independently of his/her decision to include the patient in the study
- Subject 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
- Hypersensitivity to the active substance or to any of the excipients
- Magnetic resonance imaging or cardioversion (see SmPC)
Trial locations and contacts
80 sites in 1 country.
80 sites in 1 country
Germany80 sites
Study site
Abensburg
Study site
Altenholz
Study site
Alzenau in Unterfranken
Study site
Anklam
Study site
Aschaffenburg
Study site
Bad Neustadt an der Saale
Study site
Berlin
Study site
Bielefeld
Study site
Bischofswerda
Study site
Böblingen
Study site
Bochum
Study site
Bonn
Study site
Bremen
Study site
Cologne
Study site
Cottbus
Study site
Delbrück
Study site
Dippoldiswalde
Study site
Dortmund-Kirchhörde
Study site
Dresden
Study site
Düren
Study site
Ellwangen
Study site
Erbach im Odenwald
Study site
Freiburg im Breisgau
Study site
Fulda
Study site
Gelsenkirchen
Study site
Gera
Study site
Gladenbach
Study site
Göttingen
Study site
Greifswald
Study site
Gütersloh
Study site
Halle
Study site
Heidenheim
Study site
Ilmenau
Study site
Jülich
Study site
Karlsruhe
Study site
Karlstadt am Main
Study site
Kassel
Study site
Kaufbeuren
Study site
Kleve
Study site
Königsbrück
Study site
Leipzig
Study site
Lemgo
Study site
Leun-Biskirchen
Study site
Lippstadt
Study site
Lohr a. Main
Study site
Ludwigsfelde
Study site
Malchin
Study site
Mannheim
Study site
Marburg
Study site
Marburg-Cappel
Study site
München
Study site
Neuburg an der Donau
Study site
Neusäß
Study site
Oberursel
Study site
Oelde
Study site
Osnabrück
Study site
Osterode am Harz
Study site
Paderborn
Study site
Potsdam
Study site
Remscheid
Study site
Rheda-Wiedenbrück
Study site
Rostock
Study site
Schriesheim
Study site
Schwäbisch Gmünd
Study site
Schwalmstadt-Treysa
Study site
Schwedt
Study site
Schwerin
Study site
Senftenberg
Study site
Soest
Study site
Stadtroda
Study site
Stralsund
Study site
Stuttgart
Study site
Teupitz
Study site
Ulm
Study site
Westerstede
Study site
Wiesbaden
Study site
Wismar
Study site
Wolfsburg
Study site
Zschadrass
Study site
Zwickau
About this study
Official title: Non-Interventional Study (NIS) in Patients With Restless Legs Syndrome (RLS) to Assess the Effectiveness and Safety of Neupro® in Daily Practise
This non-interventional observational study is designed to gain data for Neupro® in restless legs syndrome (RLS) under real life conditions in line with the summary of product characteristics (SmPC) related to effectiveness, tolerability and switching practice from other dopaminergic drugs as well as titration schemes.
Read the detailed description
There is a total of 64 subjects recorded as having discontinued due to Adverse Events. Documentation of Visit 2 and Visit 3, where the reason for discontinuation was documented, was not available for all subjects. From the documentation on the Adverse Events page in the Case Report Form, it is known that 100 subjects discontinued due to Adverse Events.
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
- Conditions
- Idiopathic Restless Legs Syndrome
- Being tested
- Neupro®
- Keywords
- Rotigotine, Neupro®, Restless Legs Syndrome
- 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.
Neupro®Drug
Neupro® is the exposure/intervention of interest in this non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Neupro® | Routine treatment in accordance with the local marketing authorization for Neupro® in RLS Receives: Drug: Neupro® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Restless Legs Syndrome (RLS) at Bedtime
Severity of RLS at bedtime measured as change from baseline to end of observation period (Item 2 RLS-6 scale).
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Measured: From Baseline to end of Observation Period (3 months).
Severity of Restless Legs Syndrome (RLS) During the Night
Severity of RLS during the night measured as change from baseline to end of observation period (Item 3 RLS-6 scale).
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Measured: From Baseline to end of Observation Period (3 months).
Secondary outcomes (4)
Satisfaction With Sleep
Satisfaction with sleep measured as change from baseline to end of observation period (Item 1 RLS-6 scale).
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Measured: From Baseline to end of Observation Period (3 months).
Severity of Restless Legs Syndrome (RLS) at Daytime at Rest
Severity of RLS at daytime at rest measured as change from baseline to end of observation period (Item 4 RLS-6 scale).
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Measured: From Baseline to end of Observation Period (3 months).
Severity of Restless Legs Syndrome (RLS) at Daytime in Activity
Severity of RLS at daytime in activity measured as change from baseline to end of observation period (Item 5 RLS-6 scale).
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Measured: From Baseline to end of Observation Period (3 months).
Daytime Tiredness
Daytime tiredness measured as change from baseline to end of observation period (Item 6 RLS-6 scale).
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Measured: From Baseline to end of Observation Period (3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2011
- Study completionJul 2011
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 Idiopathic 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
- 687 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113710
- Sponsor's protocol ID
- SP0948
- Acronym
- RLS-Practise
- Status last verified
- Aug 2012
- First submitted
- 28 Apr 2010
- Last updated
- 28 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Stiasny-Kolster K, Berg D, Hofmann WE, Berkels R, Grieger F, Lauterbach T, Schollmayer E, Bachmann CG. Effectiveness and tolerability of rotigotine transdermal patch for the treatment of restless legs syndrome in a routine clinical practice setting in Germany. Sleep Med. 2013 Jun;14(6):475-81. doi: 10.1016/j.sleep.2013.02.013. Epub 2013 May 11.
PubMed 23668924
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study (NIS) in Patients With Restless Legs Syndrome (RLS) to Assess the Effectiveness and Safety of Neupro® in Daily Practise
- ClinicalTrials.gov ID
- NCT01113710
- Acronym / sponsor ID
- RLS-Practise / SP0948
- Conditions
- Idiopathic Restless Legs Syndrome
- Keywords
- Rotigotine, Neupro®, Restless Legs Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 687 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Posted 28 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-interventional observational study is designed to gain data for Neupro® in restless legs syndrome (RLS) under real life conditions in line with the summary of product characteristics (SmPC) related to effectiveness, tolerability and switching practice from other dopaminergic drugs as well as titration schemes.
Detailed description
There is a total of 64 subjects recorded as having discontinued due to Adverse Events. Documentation of Visit 2 and Visit 3, where the reason for discontinuation was documented, was not available for all subjects. From the documentation on the Adverse Events page in the Case Report Form, it is known that 100 subjects discontinued due to Adverse Events.
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neupro® | – | Drug: Neupro®Routine treatment in accordance with the local marketing authorization for Neupro® in RLS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a diagnosis of moderate to severe idiopathic RLS treated with Neupro® in routine daily practice.
Key inclusion criteria (5 listed)
- It was recommended that the patient's treatment was in accordance with the local marketing authorization (MA) for Neupro®
- The patient must have a diagnosis of moderate to severe idiopathic RLS
- The patient is considered reliable and capable of adhering to the visit schedule or medication administration according to the judgment of the investigator
- The decision to prescribe the drug has been made by the physician independently of his/her decision to include the patient in the study
- Subject 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 (2 listed)
- Hypersensitivity to the active substance or to any of the excipients
- Magnetic resonance imaging or cardioversion (see SmPC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neupro®Neupro® is the exposure/intervention of interest in this non-interventional study. | Drug | Neupro® |
Primary outcome
Severity of Restless Legs Syndrome (RLS) at Bedtime
Time frame: From Baseline to end of Observation Period (3 months).
Severity of RLS at bedtime measured as change from baseline to end of observation period (Item 2 RLS-6 scale). The Last Observation Carried Forward (LOCF) method was utilized for all outcomes. The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Severity of Restless Legs Syndrome (RLS) During the Night
Time frame: From Baseline to end of Observation Period (3 months).
Severity of RLS during the night measured as change from baseline to end of observation period (Item 3 RLS-6 scale). The Last Observation Carried Forward (LOCF) method was utilized for all outcomes. The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
4 secondary outcomes
Satisfaction With Sleep
Time frame: From Baseline to end of Observation Period (3 months).
Severity of Restless Legs Syndrome (RLS) at Daytime at Rest
Time frame: From Baseline to end of Observation Period (3 months).
Severity of Restless Legs Syndrome (RLS) at Daytime in Activity
Time frame: From Baseline to end of Observation Period (3 months).
Daytime Tiredness
Time frame: From Baseline to end of Observation Period (3 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23668924Stiasny-Kolster K, Berg D, Hofmann WE, Berkels R, Grieger F, Lauterbach T, Schollmayer E, Bachmann CG. Effectiveness and tolerability of rotigotine transdermal patch for the treatment of restless legs syndrome in a routine clinical practice setting in Germany. Sleep Med. 2013 Jun;14(6):475-81. doi: 10.1016/j.sleep.2013.02.013. Epub 2013 May 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)
80 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Restless Legs Syndrome, run by UCB Pharma at 80 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 5 inclusion and 2 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 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 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 28 Sep 2012). 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?
Severity of Restless Legs Syndrome (RLS) at Bedtime (time frame: From Baseline to end of Observation Period (3 months).). The study lists 2 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 NCT01113710, 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 28 Sep 2012.