Restless Legs Syndrome
Conditions
Brief summary
Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study
Detailed description
Study Design:
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Moderate to severe Primary Restless Legs Syndrome 2. Male or female patients aged at least 18 years
Exclusion criteria
1. Any contraindications according to Basic Product Information (Company Core Data Sheet) or local Labelling; hypersensitivity to pramipexole or to any of the excipients. 2. Ongoing treatment with Mirapex 3. Pregnant and breastfeeding women 4. Concomitant pharmacologic treatment with other dopaminergic drugs(including L-dopa) 5. Secondary RLS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Reported Adverse Events | Up to 4 weeks | If there is a dose titration, another 4 weeks should be followed up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment | before and after the treatment with Mirapex (at least 4 weeks after the end of titration) | a change in 10-item scale rated by the patient on 5 levels with a minimum (none) sum score of 0 to maximum (very severe) sum score of 40 |
| Patient-Global Impressions (PGI-I) | before and after the treatment with Mirapex (at least 4 weeks after the end of titration) | PGI comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse. |
| Clinical Global Impressions-Global Improvement (CGI-I) | before and after the treatment with Mirapex (at least 4 weeks after the end of titration) | CGI-I comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Restless Legs Syndrome (RLS) Patients with RLS who had initiated with Mirapex | 651 |
| Total | 651 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Missing efficacy evaluation | 3 |
| Overall Study | Treatment duration is less than 4 weeks | 21 |
Baseline characteristics
| Characteristic | Patients With Restless Legs Syndrome (RLS) |
|---|---|
| Age, Continuous | 60.9 Years STANDARD_DEVIATION 13.2 |
| Sex/Gender, Customized Female | 369 Participants |
| Sex/Gender, Customized Male | 276 Participants |
| Sex/Gender, Customized Not reported | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 651 |
| serious Total, serious adverse events | 0 / 651 |
Outcome results
Primary
Number of Reported Adverse Events
If there is a dose titration, another 4 weeks should be followed up
Time frame: Up to 4 weeks
Population: Patients with RLS who took at least one dose of Mirapex - Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirapex | Number of Reported Adverse Events | Nervous system disorders | 1 cases |
| Mirapex | Number of Reported Adverse Events | Gastrointestinal disorders | 8 cases |
| Mirapex | Number of Reported Adverse Events | General disorders and admin site conditions | 2 cases |
| Mirapex | Number of Reported Adverse Events | Psychiatric disorders | 1 cases |
Secondary
Clinical Global Impressions-Global Improvement (CGI-I)
CGI-I comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse.
Time frame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration)
Population: Patients whose CGI-I were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirapex | Clinical Global Impressions-Global Improvement (CGI-I) | Very much improved | 188 patients |
| Mirapex | Clinical Global Impressions-Global Improvement (CGI-I) | Much improved | 351 patients |
| Mirapex | Clinical Global Impressions-Global Improvement (CGI-I) | Minimally improved | 49 patients |
| Mirapex | Clinical Global Impressions-Global Improvement (CGI-I) | No change | 35 patients |
| Mirapex | Clinical Global Impressions-Global Improvement (CGI-I) | Minimally worse | 3 patients |
| Mirapex | Clinical Global Impressions-Global Improvement (CGI-I) | Much worse | 1 patients |
| Mirapex | Clinical Global Impressions-Global Improvement (CGI-I) | Very much worse | 0 patients |
Secondary
International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment
a change in 10-item scale rated by the patient on 5 levels with a minimum (none) sum score of 0 to maximum (very severe) sum score of 40
Time frame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration)
Population: Patients whose IRLS scores were assessed at the baseline and at 4 weeks after the end of titration. Efficacy data set (Intent to Treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirapex | International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment | -14.7 Units on a scale | Standard Deviation 7.6 |
Secondary
Patient-Global Impressions (PGI-I)
PGI comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse.
Time frame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration)
Population: Patients whose PGI were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirapex | Patient-Global Impressions (PGI-I) | Very much improved | 177 patients |
| Mirapex | Patient-Global Impressions (PGI-I) | Much improved | 360 patients |
| Mirapex | Patient-Global Impressions (PGI-I) | Minimally improved | 45 patients |
| Mirapex | Patient-Global Impressions (PGI-I) | No change | 42 patients |
| Mirapex | Patient-Global Impressions (PGI-I) | Minimally worse | 2 patients |
| Mirapex | Patient-Global Impressions (PGI-I) | Much worse | 1 patients |
| Mirapex | Patient-Global Impressions (PGI-I) | Very much worse | 0 patients |