Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02248142
Collaborator
(none)
1,029
Study Details
Study Description
Brief Summary
Study to evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
1029 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Sifrol® (Pramipexole) Impact on RLS: A 12-weeks Observational Study in Patients With Primary RLS
Study Start Date
:
Feb 1, 2006
Actual Primary Completion Date
:
Jan 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| RLS patients
|
Drug: Pramipexole
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Assessment of RLS symptoms (IRLS) on a 4-point rating scale [up to 12 weeks]
- Assessment of RLS severity on a 6-point rating scale [up to 12 weeks]
Secondary Outcome Measures
- Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale [up to 12 weeks]
- Global assessment of efficacy by investigator on a 5-point scale [after 12 weeks]
- Number of patients with adverse events [up to 12 weeks]
- Time to reach maintenance dose of pramipexole [up to 12 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
Patients suffering from primary RLS who are planned to be initiated on treatment with pramipexole as part of the routine care could be included into the study
-
Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pretreated with dopaminergic medication
-
Male or female patients of any age
Exclusion Criteria:
- Treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SPC) for the treatment with pramipexole
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02248142
Other Study ID Numbers:
- 248.623
First Posted:
Sep 25, 2014
Last Update Posted:
Sep 25, 2014
Last Verified:
Sep 1, 2014