Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise

Non-Interventional Study (NIS) in Patients With Restless Legs Syndrome (RLS) to Assess the Effectiveness and Safety of Neupro® in Daily Practise

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01113710

Acronym

RLS-Practise

Enrollment

687

Registered

2010-04-30

Start date

2010-05-31

Completion date

2011-07-31

Last updated

2012-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Restless Legs Syndrome

Keywords

Rotigotine, Neupro®, Restless Legs Syndrome

Brief 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.

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.

Interventions

DRUGNeupro®

Neupro® is the exposure/intervention of interest in this non-interventional study.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Hypersensitivity to the active substance or to any of the excipients * Magnetic resonance imaging or cardioversion (see SmPC)

Design outcomes

Primary

Measure	Time frame	Description
Severity of Restless Legs Syndrome (RLS) at Bedtime	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	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).

Secondary

Measure	Time frame	Description
Satisfaction With Sleep	From Baseline to end of Observation Period (3 months).	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).
Severity of Restless Legs Syndrome (RLS) at Daytime at Rest	From Baseline to end of Observation Period (3 months).	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).
Severity of Restless Legs Syndrome (RLS) at Daytime in Activity	From Baseline to end of Observation Period (3 months).	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).
Daytime Tiredness	From Baseline to end of Observation Period (3 months).	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).

Countries

Germany

Participant flow

Recruitment details

This study started in May 2010 with subjects from Germany. The study completed in July 2011. The Full Analysis Set is used for study outcome measures. The Enrolled Set is reflected in the Participant Flow and Study Demographics. Age demographic information is missing for 1 subject and gender information is missing for 5 subjects.

Pre-assignment details

The Participant Flow contains single and multiple reasons for Other subject discontinuation. Therefore, individual Other reasons are listed below: Augmentation: 7 Problems with adhesiveness of patch: 6 Pruritus: 1 Tiredness: 1 Less effective than previous medication: 1 Application site reactions: 2 Neurotic: 1

Participants by arm

Arm	Count
Neupro® Routine treatment in accordance with the local marketing authorization for Neupro® in RLS	687
Total	687

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	64
Overall Study	Adverse Event/Other	5
Overall Study	Compliance/Efficacy/Adverse Event	1
Overall Study	Compliance/Efficacy/AE/Other	1
Overall Study	Compliance/Efficacy/Subject Withdrawal	1
Overall Study	Compliance/Lost to Follow up/Efficacy/AE	1
Overall Study	Compliance/Lost to Follow up/Pt Withdraw	2
Overall Study	Compliance/Subject Withdrawal/AE	1
Overall Study	Efficacy/Subject Withdrawal/AE	2
Overall Study	Efficacy/Withdrawal by Subject/Other	1
Overall Study	Lack of Efficacy	41
Overall Study	Lack of Efficacy/Adverse Event	3
Overall Study	Lack of Efficacy/Other	4
Overall Study	Lack of Efficacy/Withdrawal by Subject	13
Overall Study	Lack of Patient's Compliance	8
Overall Study	Lack of Patient's Compliance/Other	1
Overall Study	Lost to Follow-up	20
Overall Study	Lost to Follow up/Withdrawal by Subject	2
Overall Study	No Information Available	40
Overall Study	Other	7
Overall Study	Patient Compliance/Withdrawal by Subject	4
Overall Study	Patient's Compliance/Lost to Follow up	5
Overall Study	Subject Did Not Receive Neupro	3
Overall Study	Withdrawal by Subject	28
Overall Study	Withdrawal by Subject/Adverse Event	11

Baseline characteristics

Characteristic	Neupro®
Age Continuous	65.6 years STANDARD_DEVIATION 12.6
Age, Customized <=18 years	0 Participants
Age, Customized >=65 years	408 Participants
Age, Customized Between 18 and 65 years	278 Participants
Age, Customized Missing	1 Participants
Region of Enrollment Germany	687 participants
Sex/Gender, Customized Female	494 Participants
Sex/Gender, Customized Male	188 Participants
Sex/Gender, Customized Missing	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	121 / 684
serious Total, serious adverse events	8 / 684

Outcome results

Primary

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).