N/A
Completed N=651
Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS
Source: ClinicalTrials.gov NCT01170091 ↗Enrolled (actual)
651
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Number of Reported Adverse Events — 8; 1; 2; 1 cases
Summary
Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Reported Adverse Events |
8; 1; 2; 1 | — |
| SECONDARY International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment |
-14.7 | — |
| SECONDARY Patient-Global Impressions (PGI-I) |
177; 360; 45; 42; 2; 1 | — |
| SECONDARY Clinical Global Impressions-Global Improvement (CGI-I) |
188; 351; 49; 35; 3; 1 | — |
Eligibility Criteria
Inclusion criteria
- Moderate to severe Primary Restless Legs Syndrome
- Male or female patients aged at least 18 years
Exclusion criteria
- Any contraindications according to Basic Product Information (Company Core Data Sheet) or local Labelling; hypersensitivity to pramipexole or to any of the excipients.
- Ongoing treatment with Mirapex
- Pregnant and breastfeeding women
- Concomitant pharmacologic treatment with other dopaminergic drugs(including L-dopa)
- Secondary RLS
Data sourced from ClinicalTrials.gov (NCT01170091). 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. Informational only — not medical advice.