Trial Outcomes & Findings for Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS) (NCT NCT00654498)
NCT ID: NCT00654498
Last Updated: 2014-06-09
Results Overview
The IRLS was a 10-item self patient's rating scale for assessing severity of restless legs syndrome symptoms with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 (no symptoms) to 40 (worst possible symptoms).
COMPLETED
PHASE3
306 participants
Baseline and 6 weeks of treatment
2014-06-09
Participant Flow
Participant milestones
| Measure |
Pramipexole
4 weeks of individual dose titration starting with 0.125 mg pramipexole, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily
|
Placebo
1 tablet (Pramipexole 0.125 mg matching placebo tablet), or 1 or 2 or 3 tablets (Pramipexole 0.25 mg matching placebo tablet), once daily
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
103
|
|
Overall Study
COMPLETED
|
189
|
91
|
|
Overall Study
NOT COMPLETED
|
14
|
12
|
Reasons for withdrawal
| Measure |
Pramipexole
4 weeks of individual dose titration starting with 0.125 mg pramipexole, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily
|
Placebo
1 tablet (Pramipexole 0.125 mg matching placebo tablet), or 1 or 2 or 3 tablets (Pramipexole 0.25 mg matching placebo tablet), once daily
|
|---|---|---|
|
Overall Study
Not Treated
|
1
|
0
|
|
Overall Study
Adverse Event
|
6
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Other reason not defined above
|
4
|
5
|
Baseline Characteristics
Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)
Baseline characteristics by cohort
| Measure |
Pramipexole
n=202 Participants
|
Placebo
n=103 Participants
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.46 Years
STANDARD_DEVIATION 11.88 • n=99 Participants
|
56.86 Years
STANDARD_DEVIATION 11.89 • n=107 Participants
|
56.6 Years
STANDARD_DEVIATION 11.87 • n=206 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeks of treatmentPopulation: Full Analysis Set (FAS), All patients randomized, treated, having data for primary endpoint
The IRLS was a 10-item self patient's rating scale for assessing severity of restless legs syndrome symptoms with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 (no symptoms) to 40 (worst possible symptoms).
Outcome measures
| Measure |
Pramipexole
n=195 Participants
|
Placebo
n=92 Participants
|
|---|---|---|
|
The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).
|
-15.87 Score on a scale
Standard Error 0.66
|
-11.35 Score on a scale
Standard Error 0.92
|
PRIMARY outcome
Timeframe: 6 weeks of treatmentCGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved)and 2 (much improved.
Outcome measures
| Measure |
Pramipexole
n=193 Participants
|
Placebo
n=92 Participants
|
|---|---|---|
|
The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of "Much Improved" and "Very Much Improved"
|
0.819 Proportion of Patients
|
0.543 Proportion of Patients
|
SECONDARY outcome
Timeframe: 6 weeks of treatmentresponders is defined as the total score in IRLS changed ≥ 50%from baseline calculated in the full analysis set population.
Outcome measures
| Measure |
Pramipexole
n=195 Participants
|
Placebo
n=92 Participants
|
|---|---|---|
|
The Proportion of IRLS Responders
|
0.738 Proportion of Patients
|
0.489 Proportion of Patients
|
SECONDARY outcome
Timeframe: 6 weeks of treatmentPGI was a one-question scale with 7 degrees to assess patient's overall condition, ranging from very much better to very much worse. The responder are defined as patients with their assessment of "much better" or "very much better".
Outcome measures
| Measure |
Pramipexole
n=194 Participants
|
Placebo
n=92 Participants
|
|---|---|---|
|
The Proportion of Patient Global Impression(PGI) Responders
|
0.686 Proportion of participants
|
0.435 Proportion of participants
|
SECONDARY outcome
Timeframe: week 6 of treatmentThe ESS is a self-administered instrument to assess the patients likelihood of falling asleep in various activities of daily living; the maximum score is 24 indicating a very high level of daytime sleepiness and a high likelihood of falling asleep.
Outcome measures
| Measure |
Pramipexole
n=194 Participants
|
Placebo
n=92 Participants
|
|---|---|---|
|
The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10
|
0.108 Proportion of Patients
|
0.054 Proportion of Patients
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks of treatmentRLS-6 rating scales comprises 6 questions Satisfaction of sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the satisfaction of sleep.
Outcome measures
| Measure |
Pramipexole
n=194 Participants
|
Placebo
n=92 Participants
|
|---|---|---|
|
the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales
|
-4.52 Score on a scale
Standard Deviation 0.21
|
-3.04 Score on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks of treatmentRLS-6 rating scales comprises 6 questions. The severity of RLS at time of falling sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS at time of falling sleep
Outcome measures
| Measure |
Pramipexole
n=194 Participants
|
Placebo
n=92 Participants
|
|---|---|---|
|
The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales.
|
-4.9 Score on a scale
Standard Deviation 0.21
|
-3.53 Score on a scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks of treatmentRLS-6 rating scales comprises 6 questions. The severity of RLS during the night is one of the 6 questions. The patient should give a rate between 0 ("none/Not at all") to 10 ("very severe") for the severity of RLS during the night.
Outcome measures
| Measure |
Pramipexole
n=194 Participants
|
Placebo
n=92 Participants
|
|---|---|---|
|
The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales.
|
-4.68 Score on a scale
Standard Deviation 0.21
|
-3.32 Score on a scale
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks of treatmentRLS-6 rating scales comprises 6 questions. The severity of RLS during the test at day is one of the 6 questions. The patient should give a rate between 0 ("none/Not at all") to 10 ("very severe") for the severity of RLS during the rest at day.
Outcome measures
| Measure |
Pramipexole
n=194 Participants
|
Placebo
n=92 Participants
|
|---|---|---|
|
The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales.
|
-2.9 Score on a scale
Standard Deviation 0.17
|
-2.36 Score on a scale
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks of treatmentRLS-6 rating scales comprises 6 questions. The severity of RLS during the activities at day is one of the 6 questions. The patient should give a rate between 0 ("none/Not at all") to 10 ("very severe") for the severity of RLS during the activity at day.
Outcome measures
| Measure |
Pramipexole
n=194 Participants
|
Placebo
n=92 Participants
|
|---|---|---|
|
The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale
|
-0.93 Score on a scale
Standard Deviation 0.12
|
-0.61 Score on a scale
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks of treatmentRLS-6 rating scales comprises 6 questions. The intensity of tiredness and sleepiness at day is one of the 6 questions. The patient should give a rate between 0 ("none/Not at all") to 10 ("very severe") for the intensity of tiredness and sleepiness at day.
Outcome measures
| Measure |
Pramipexole
n=194 Participants
|
Placebo
n=92 Participants
|
|---|---|---|
|
The Mean Change From Baseline in the Intensity of Tiredness and Sleepiness at Day of RLS-6 Rating Scale
|
-2.96 Score on a scale
Standard Deviation 0.16
|
-2.25 Score on a scale
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks of treatmentVAS is for assessment of RLS-associated pain. The patient was asked "How severe was your RLS associated pain in legs or arms during the past week?". No pain:0; very worst pain:10
Outcome measures
| Measure |
Pramipexole
n=194 Participants
|
Placebo
n=92 Participants
|
|---|---|---|
|
The Change From Baseline in Visual Analogue Scales (VAS)
|
2.6 Score on a scale
Standard Deviation 2.5
|
3.9 Score on a scale
Standard Deviation 3
|
Adverse Events
Pramipexole
Placebo
Serious adverse events
| Measure |
Pramipexole
n=202 participants at risk
|
Placebo
n=103 participants at risk
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.50%
1/202 • 6 Weeks
|
0.00%
0/103 • 6 Weeks
|
|
Injury, poisoning and procedural complications
Injury
|
0.50%
1/202 • 6 Weeks
|
0.00%
0/103 • 6 Weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.50%
1/202 • 6 Weeks
|
0.00%
0/103 • 6 Weeks
|
Other adverse events
| Measure |
Pramipexole
n=202 participants at risk
|
Placebo
n=103 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.9%
26/202 • 6 Weeks
|
7.8%
8/103 • 6 Weeks
|
|
Nervous system disorders
Dizziness
|
17.3%
35/202 • 6 Weeks
|
8.7%
9/103 • 6 Weeks
|
|
Nervous system disorders
Headache
|
9.9%
20/202 • 6 Weeks
|
1.9%
2/103 • 6 Weeks
|
|
Nervous system disorders
Somnolence
|
13.9%
28/202 • 6 Weeks
|
8.7%
9/103 • 6 Weeks
|
|
Psychiatric disorders
Insomnia
|
2.0%
4/202 • 6 Weeks
|
5.8%
6/103 • 6 Weeks
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
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