Observational Study of Sifrol® in Patients With Primary R... | NCT02248155

Studies
Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)

NCT02248155

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 25, 2014Estimated

Enrollment

2,644Actual

Phase

Not provided

Conditions

Restless Legs Syndrome

Interventions

Pramipexole

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Not provided

First Submitted Date

Sep 22, 2014

First Submission Date that Met QC Criteria

Sep 22, 2014

First Posted Date

Sep 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2014

Last Update Posted Date

Sep 25, 2014Estimated

Description Module

Brief Summary

The objectives of this Post Marketing Surveillance (PMS) are:

Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical Global Impression Improvement scale (CGI- I)
Evaluation of the time to reaching maintenance dose of pramipexole
Evaluation of work productivity impairment associated with RLS based on the Work Productivity and Activity Impairment Questionnaire (WPAI) questionnaire

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,644Actual

Label	Type	Description	Intervention Names
RLS patients			Drug: Pramipexole

Name	Type	Description	Arm Group Labels	Other Names
Pramipexole	Drug		RLS patients	Sifrol®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of RLS symptoms (IRLS) on a 4-point rating scale		up to 12 weeks
Change from Baseline in WPAI by means of a patient questionnaire		Baseline, 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with adverse drug reactions		up to 12 weeks
Global assessment of efficacy by investigator on a 5-point scale		after 12 weeks
Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients suffering from primary RLS who are eligible for Pramipexol (PPX) treatment could be included into the study
Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pre-treated with dopaminergic medication
Male of female patients of any age

Exclusion Criteria:

The treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients suffering from moderate to severe RLS recruited at office-based general practitioners and interists

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D012148	Restless Legs Syndrome

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077487	Pramipexole

Ancestor Terms

ID	Term
D052160	Benzothiazoles
D013844	Thiazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided