Restless Legs Syndrome
Conditions
Brief summary
The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine medical practice.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient with Restless Legs Syndrome
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Drug-related Adverse Events | 12 Months | Number of patients with drug-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS) | after 12 months or at the end of observation | International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient With Restless Legs Syndrome Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day | 510 |
| Total | 510 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | case report form (CRF) not collected | 5 |
Baseline characteristics
| Characteristic | Patient With Restless Legs Syndrome |
|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 16.8 |
| Sex: Female, Male Female | 298 Participants |
| Sex: Female, Male Male | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 510 |
| serious Total, serious adverse events | 10 / 510 |
Outcome results
Primary
Incidence of Drug-related Adverse Events
Number of patients with drug-related adverse events
Time frame: 12 Months
Population: Safety set: all patients who were documented to have taken at least one dose of pramipexole except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient With Restless Legs Syndrome | Incidence of Drug-related Adverse Events | 76 participants |
Secondary
Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)
International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome.
Time frame: after 12 months or at the end of observation
Population: Efficacy set: The patient set included all patients in the safety set with approved indication RLS and had IRLS total score measurement at baseline and at least one post-baseline time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient With Restless Legs Syndrome | Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS) | -13.42 Score on a scale | Standard Error 10.4 |