NCT02248155

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,644

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

7 months

First QC Date

September 22, 2014

Last Update Submit

September 22, 2014

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • 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

    up to 12 weeks

  • Time to reach pramipexol maintenance dose

    up to 12 weeks

Study Arms (1)

RLS patients

Drug: Pramipexole

Interventions

PramipexoleDRUG
Also known as: Sifrol®
RLS patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2014

First Posted

September 25, 2014

Study Start

April 1, 2006

Primary Completion

November 1, 2006

Last Updated

September 25, 2014

Record last verified: 2014-09