Trial · NCT00654498
Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)
NCT00654498, Phase 3, Completed, Boehringer Ingelheim; results first posted 2010-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS). Trials, record NCT00654498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00654498
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)
- NCT number
- NCT00654498
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 306 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Restless Legs Syndrome
- Interventions
- Pramipexole, Placebo
- First posted
- 2008-04-08
- Last updated
- 2014-06-09
- Results first posted
- 2010-03-03
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). | Baseline and 6 weeks of treatment | 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). |
| Primary | The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of "Much Improved" and "Very Much Improved" | 6 weeks of treatment | CGI-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. |
| Secondary | The Proportion of IRLS Responders | 6 weeks of treatment | responders is defined as the total score in IRLS changed ≥ 50%from baseline calculated in the full analysis set population. |
| Secondary | The Proportion of Patient Global Impression(PGI) Responders | 6 weeks of treatment | PGI 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". |
| Secondary | The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10 | week 6 of treatment | The 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. |
| Secondary | the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales | Baseline and 6 weeks of treatment | RLS-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. |
| Secondary | The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales. | Baseline and 6 weeks of treatment | RLS-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 |
| Secondary | The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales. | Baseline and 6 weeks of treatment | RLS-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. |
| Secondary | The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales. | Baseline and 6 weeks of treatment | RLS-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. |
| Secondary | The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale | Baseline and 6 weeks of treatment | RLS-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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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). | Baseline and 6 weeks of treatment | Full Analysis Set (FAS), All patients randomized, treated, having data for primary endpoint | Score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of Much Improved and Very Much Improved | 6 weeks of treatment | Proportion of Patients | NUMBER | |
| SECONDARY | The Proportion of IRLS Responders | 6 weeks of treatment | Proportion of Patients | NUMBER | |
| SECONDARY | The Proportion of Patient Global Impression(PGI) Responders | 6 weeks of treatment | Proportion of participants | NUMBER | |
| SECONDARY | The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10 | week 6 of treatment | Proportion of Patients | NUMBER | |
| SECONDARY | the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales | Baseline and 6 weeks of treatment | Score on a scale | MEAN | |
| SECONDARY | The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales. | Baseline and 6 weeks of treatment | Score on a scale | MEAN | |
| SECONDARY | The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales. | Baseline and 6 weeks of treatment | Score on a scale | MEAN | |
| SECONDARY | The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales. | Baseline and 6 weeks of treatment | Score on a scale | MEAN | |
| SECONDARY | The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale | Baseline and 6 weeks of treatment | Score on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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). | Pramipexole | -15.87 | Standard Error 0.66 | Score on a scale | |
| 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). | Placebo | -11.35 | Standard Error 0.92 | Score on a scale | |
| The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of Much Improved and Very Much Improved | Pramipexole | 0.819 | Proportion of Patients | ||
| The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of Much Improved and Very Much Improved | Placebo | 0.543 | Proportion of Patients | ||
| The Proportion of IRLS Responders | Pramipexole | 0.738 | Proportion of Patients | ||
| The Proportion of IRLS Responders | Placebo | 0.489 | Proportion of Patients | ||
| The Proportion of Patient Global Impression(PGI) Responders | Pramipexole | 0.686 | Proportion of participants | ||
| The Proportion of Patient Global Impression(PGI) Responders | Placebo | 0.435 | Proportion of participants | ||
| The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10 | Pramipexole | 0.108 | Proportion of Patients | ||
| The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10 | Placebo | 0.054 | Proportion of Patients |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pramipexole | 203 | |
| Overall Study | STARTED | Placebo | 103 | |
| Overall Study | COMPLETED | Pramipexole | 189 | |
| Overall Study | COMPLETED | Placebo | 91 | |
| Overall Study | NOT COMPLETED | Pramipexole | 14 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Pramipexole | 26 | 202 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 8 | 103 | |
| other | Dizziness | Nervous system disorders | Pramipexole | 35 | 202 | |
| other | Dizziness | Nervous system disorders | Placebo | 9 | 103 | |
| other | Headache | Nervous system disorders | Pramipexole | 20 | 202 | |
| other | Headache | Nervous system disorders | Placebo | 2 | 103 | |
| other | Somnolence | Nervous system disorders | Pramipexole | 28 | 202 | |
| other | Somnolence | Nervous system disorders | Placebo | 9 | 103 | |
| other | Insomnia | Psychiatric disorders | Pramipexole | 4 | 202 | |
| other | Insomnia | Psychiatric disorders | Placebo | 6 | 103 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pramipexole | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pramipexole | 81 | 202 |
| Total, other adverse events | Placebo | 25 | 103 |
| Total, serious adverse events | Pramipexole | 3 | 202 |
| Total, serious adverse events | Placebo | 0 | 103 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pramipexole vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00654498
GET https://conductscience.org/api/trials/v1/NCT00654498/results?page=2