N/A
N=549
Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
Restless Legs Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00721279 ↗Enrolled (actual)
549
Serious AEs
0.4%
Results posted
Jan 2010
Primary outcome: Primary: Frequency Analysis for Baseline Pattern of RLS Symptoms — 0.7; 2.4; 19.3; 18.1 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sifrol® (pramipexole dihydrochloride) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency Analysis for Baseline Pattern of RLS Symptoms |
0.7; 2.4; 19.3; 18.1; 62.0; 55.4 | — |
| PRIMARY Change in Total Scores of IRLS (International Restless Legs Rating Scale) |
17; 16 | — |
| PRIMARY Change in Global Clinical Impression - Improvement (CGI-I) Scale |
47.0; 44.6; 45.5; 42.2; 3.0; 8.4 | — |
| PRIMARY Frequency of Adverse Events |
25; 7; 2 | — |
| PRIMARY Correlation of the Change in IRLS at End of Titration and at Final Visit |
0.0; 19.7; 80.3; 0.2; 5.4; 94.5 | — |
Summary
The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time to reaching maintenance dose of pramipexole
Eligibility Criteria
Inclusion Criteria
- Primary Restless Legs Syndrome (i.e. idiopathic RLS)
- Indication for treatment with pramipexole
- Male or female patients older than 18 years
Exclusion Criteria
- Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients
- Current treatment with pramipexole
Data sourced from ClinicalTrials.gov (NCT00721279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.