Trial · NCT00721279
Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
NCT00721279, Completed, Boehringer Ingelheim; results first posted 2010-01-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome. Trials, record NCT00721279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00721279
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
- NCT number
- NCT00721279
- Status
- Completed
- Enrollment
- 549 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Restless Legs Syndrome
- Interventions
- Sifrol® (pramipexole dihydrochloride)
- First posted
- 2008-07-24
- Last updated
- 2014-06-04
- Results first posted
- 2010-01-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency Analysis for Baseline Pattern of RLS Symptoms | Baseline | Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe. |
| Primary | Change in Total Scores of IRLS (International Restless Legs Rating Scale) | Baseline and final visit (week12) | The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS. The change from baseline was calculated as baseline minus the week 12 value. |
| Primary | Change in Global Clinical Impression - Improvement (CGI-I) Scale | baseline and final visit (week 12) | The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse |
| Primary | Frequency of Adverse Events | Up to 16 weeks | Frequency of patients with any adverse event, causally related adverse events and serious adverse events |
| Primary | Correlation of the Change in IRLS at End of Titration and at Final Visit | Up to 12 weeks | Correlation of the change in IRLS at end of titration and at final visit |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency Analysis for Baseline Pattern of RLS Symptoms | Baseline | Full analysis set (FAS) | percentage of participants | NUMBER |
| PRIMARY | Change in Total Scores of IRLS (International Restless Legs Rating Scale) | Baseline and final visit (week12) | Only those patients of the full analysis set with an evaluation of the IRLS at visit 3 were included | scores on a scale | MEDIAN |
| PRIMARY | Change in Global Clinical Impression - Improvement (CGI-I) Scale | baseline and final visit (week 12) | Full analysis set | percentage of participants | NUMBER |
| PRIMARY | Frequency of Adverse Events | Up to 16 weeks | Safety Analysis Set (SAF) | participants | NUMBER |
| PRIMARY | Correlation of the Change in IRLS at End of Titration and at Final Visit | Up to 12 weeks | Full Analysis Set (FAS) | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency Analysis for Baseline Pattern of RLS Symptoms | De-novo Patients | Mild | 0.7 | percentage of participants | |
| Frequency Analysis for Baseline Pattern of RLS Symptoms | Pre-treated Patients | Mild | 2.4 | percentage of participants | |
| Frequency Analysis for Baseline Pattern of RLS Symptoms | De-novo Patients | Moderate | 19.3 | percentage of participants | |
| Frequency Analysis for Baseline Pattern of RLS Symptoms | Pre-treated Patients | Moderate | 18.1 | percentage of participants | |
| Frequency Analysis for Baseline Pattern of RLS Symptoms | De-novo Patients | Severe | 62.0 | percentage of participants | |
| Frequency Analysis for Baseline Pattern of RLS Symptoms | Pre-treated Patients | Severe | 55.4 | percentage of participants | |
| Frequency Analysis for Baseline Pattern of RLS Symptoms | De-novo Patients | Very Severe | 18.0 | percentage of participants | |
| Frequency Analysis for Baseline Pattern of RLS Symptoms | Pre-treated Patients | Very Severe | 24.1 | percentage of participants | |
| Change in Total Scores of IRLS (International Restless Legs Rating Scale) | De-novo Patients | 17 | Inter-Quartile Range 13.00 to 22.00 | scores on a scale | |
| Change in Total Scores of IRLS (International Restless Legs Rating Scale) | Pre-treated Patients | 16 | Inter-Quartile Range 11.00 to 22.75 | scores on a scale |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | De-novo Patients | 452 | |
| Overall Study | STARTED | Pre-treated Patients | 97 | |
| Overall Study | COMPLETED | De-novo Patients | 416 | |
| Overall Study | COMPLETED | Pre-treated Patients | 73 | |
| Overall Study | NOT COMPLETED | De-novo Patients | 36 | |
| Overall Study | NOT COMPLETED | Pre-treated Patients | 24 |
Source ClinicalTrials.gov
Adverse events8
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 |
|---|---|---|---|---|---|---|
| serious | Epilepsy | Nervous system disorders | De-novo Patients | 0 | 452 | |
| serious | Epilepsy | Nervous system disorders | Pre-treated Patients | 1 | 97 | |
| serious | Confusion | Psychiatric disorders | De-novo Patients | 0 | 452 | |
| serious | Confusion | Psychiatric disorders | Pre-treated Patients | 1 | 97 | |
| serious | Suicidal Tendency | Psychiatric disorders | De-novo Patients | 0 | 452 | |
| serious | Suicidal Tendency | Psychiatric disorders | Pre-treated Patients | 1 | 97 | |
| serious | Depression | Psychiatric disorders | De-novo Patients | 0 | 452 | |
| serious | Depression | Psychiatric disorders | Pre-treated Patients | 1 | 97 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | De-novo Patients | ||
| Total, all-cause mortality | Pre-treated Patients | ||
| Total, other adverse events | De-novo Patients | 0 | 452 |
| Total, other adverse events | Pre-treated Patients | 0 | 97 |
| Total, serious adverse events | De-novo Patients | 0 | 452 |
| Total, serious adverse events | Pre-treated Patients | 2 | 97 |
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 |
|---|
| De-novo Patients vs Pre-treated Patients: 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/NCT00721279
GET https://conductscience.org/api/trials/v1/NCT00721279/results?page=2