Trial Outcomes & Findings for Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome (NCT NCT01174459)
NCT ID: NCT01174459
Last Updated: 2014-08-29
Results Overview
Number of patients with drug-related adverse events
Recruitment status
COMPLETED
Target enrollment
571 participants
Primary outcome timeframe
12 Months
Results posted on
2014-08-29
Participant Flow
Participant milestones
| Measure |
Patient With Restless Legs Syndrome
Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
|
|---|---|
|
Overall Study
STARTED
|
571
|
|
Overall Study
COMPLETED
|
566
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Patient With Restless Legs Syndrome
Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
|
|---|---|
|
Overall Study
case report form (CRF) not collected
|
5
|
Baseline Characteristics
Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome
Baseline characteristics by cohort
| Measure |
Patient With Restless Legs Syndrome
n=510 Participants
Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
|
|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 16.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
298 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: 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.
Number of patients with drug-related adverse events
Outcome measures
| Measure |
Patient With Restless Legs Syndrome
n=510 Participants
Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
|
|---|---|
|
Incidence of Drug-related Adverse Events
|
76 participants
|
SECONDARY outcome
Timeframe: after 12 months or at the end of observationPopulation: 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.
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.
Outcome measures
| Measure |
Patient With Restless Legs Syndrome
n=407 Participants
Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
|
|---|---|
|
Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)
|
-13.42 Score on a scale
Standard Error 10.40
|
Adverse Events
Patient With Restless Legs Syndrome
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patient With Restless Legs Syndrome
n=510 participants at risk
Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
|
|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
|
Gastrointestinal disorders
Ileus
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
|
Hepatobiliary disorders
Cholangitis
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
|
Nervous system disorders
Cerebral infarction
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
|
Psychiatric disorders
Impulse-control disorder
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
|
Psychiatric disorders
Somatic hallucination
|
0.20%
1/510 • During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER