Trial · NCT02231918
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
NCT02231918, Phase 2, Completed, Boehringer Ingelheim; results first posted 2015-10-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS). Trials, record NCT02231918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02231918
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
- NCT number
- NCT02231918
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Restless Legs Syndrome
- Interventions
- MIRAPEX® - low, MIRAPEX® - medium, MIRAPEX® - high
- First posted
- 2014-09-04
- Last updated
- 2015-10-06
- Results first posted
- 2015-10-06
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss). |
| Primary | Cmin,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss). |
| Primary | Cpre,N | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N). |
| Primary | Cavg | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Average concentration of the analyte in plasma at steady state (Cavg). |
| Primary | Tmax,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Time from dosing to maximum concentration at steady state (Tmax,ss). |
| Primary | Tmin,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Time from dosing to minimum concentration at steady state (Tmin,ss ). |
| Primary | AUCτ,ss | 0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1. | Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ). |
| Primary | λz,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Terminal rate constant in plasma at steady state (λz,ss ). |
| Primary | t1/2,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Terminal half-life of the analyte in plasma at steady state (t1/2,ss ). |
| Primary | MRTpo,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Mean residence time of the analyte in the body at steady state (MRTpo,ss). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Cmin,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Cpre,N | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Cavg | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Tmax,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis. | hours | MEDIAN |
| PRIMARY | Tmin,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Pharmacokinetic Set (PK): All evaluable subjects who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis. | hours | MEDIAN |
| PRIMARY | AUCτ,ss | 0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1. | Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis. | ng*h/mL | GEOMETRIC_MEAN |
| PRIMARY | λz,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis. | 1/h | GEOMETRIC_MEAN |
| PRIMARY | t1/2,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis. | hours | GEOMETRIC_MEAN |
| PRIMARY | MRTpo,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis. | h | GEOMETRIC_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group261
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax,ss | PPX (MIRAPEX®, 0.125 mg) | 6 to <12 years (N=5, 9, 0) | 0.633 | Geometric Coefficient of Variation 26.2 | ng/mL |
| Cmax,ss | PPX (MIRAPEX®, 0.25 mg) | 6 to <12 years (N=5, 9, 0) | 1.13 | Geometric Coefficient of Variation 35.3 | ng/mL |
| Cmax,ss | PPX (MIRAPEX®, 0.5 mg) | 6 to <12 years (N=5, 9, 0) | NA | Geometric Coefficient of Variation NA | ng/mL |
| Cmax,ss | PPX (MIRAPEX®, 0.125 mg) | 12 to <18 years(N=4, 6, 2)) | 0.396 | Geometric Coefficient of Variation 30.0 | ng/mL |
| Cmax,ss | PPX (MIRAPEX®, 0.25 mg) | 12 to <18 years(N=4, 6, 2)) | 0.677 | Geometric Coefficient of Variation 40.3 | ng/mL |
| Cmax,ss | PPX (MIRAPEX®, 0.5 mg) | 12 to <18 years(N=4, 6, 2)) | NA | Geometric Coefficient of Variation NA | ng/mL |
| Cmin,ss | PPX (MIRAPEX®, 0.125 mg) | 6 to <12 years (N=5, 9, 0) | 0.0872 | Standard Deviation 35.5 | ng/mL |
| Cmin,ss | PPX (MIRAPEX®, 0.25 mg) | 6 to <12 years (N=5, 9, 0) | 0.136 | Standard Deviation 99.5 | ng/mL |
| Cmin,ss | PPX (MIRAPEX®, 0.5 mg) | 6 to <12 years (N=5, 9, 0) | NA | Standard Deviation NA | ng/mL |
| Cmin,ss | PPX (MIRAPEX®, 0.125 mg) | 12 to <18 years(N=4, 6, 2) | 0.0972 | Standard Deviation 37.5 | ng/mL |
1 to 10 of 261Source ClinicalTrials.gov
See all 261 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PPX (MIRAPEX®, 0.125 mg) | 9 | |
| Overall Study | STARTED | PPX (MIRAPEX®, 0.25 mg) | 15 | |
| Overall Study | STARTED | PPX (MIRAPEX®, 0.5 mg) | 2 | |
| Overall Study | COMPLETED | PPX (MIRAPEX®, 0.125 mg) | 9 | |
| Overall Study | COMPLETED | PPX (MIRAPEX®, 0.25 mg) | 14 | |
| Overall Study | COMPLETED | PPX (MIRAPEX®, 0.5 mg) | 1 | |
| Overall Study | NOT COMPLETED | PPX (MIRAPEX®, 0.125 mg) | 0 | |
| Overall Study | NOT COMPLETED | PPX (MIRAPEX®, 0.25 mg) | 1 | |
| Overall Study | NOT COMPLETED | PPX (MIRAPEX®, 0.5 mg) | 1 |
Source ClinicalTrials.gov
Adverse events27
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 | MIRAPEX® (0.125 mg) | 0 | 9 | |
| other | Nausea | Gastrointestinal disorders | MIRAPEX® (0.25 mg) | 0 | 15 | |
| other | Nausea | Gastrointestinal disorders | MIRAPEX® (0.5 mg) | 1 | 2 | |
| other | Vomiting | Gastrointestinal disorders | MIRAPEX® (0.125 mg) | 0 | 9 | |
| other | Vomiting | Gastrointestinal disorders | MIRAPEX® (0.25 mg) | 1 | 15 | |
| other | Vomiting | Gastrointestinal disorders | MIRAPEX® (0.5 mg) | 1 | 2 | |
| other | Fatigue | General disorders | MIRAPEX® (0.125 mg) | 1 | 9 | |
| other | Fatigue | General disorders | MIRAPEX® (0.25 mg) | 0 | 15 | |
| other | Fatigue | General disorders | MIRAPEX® (0.5 mg) | 0 | 2 | |
| other | Infusion site erythema | General disorders | MIRAPEX® (0.125 mg) | 0 | 9 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MIRAPEX® (0.125 mg) | ||
| Total, all-cause mortality | MIRAPEX® (0.25 mg) | ||
| Total, all-cause mortality | MIRAPEX® (0.5 mg) | ||
| Total, other adverse events | MIRAPEX® (0.125 mg) | 2 | 9 |
| Total, other adverse events | MIRAPEX® (0.25 mg) | 3 | 15 |
| Total, other adverse events | MIRAPEX® (0.5 mg) | 1 | 2 |
| Total, serious adverse events | MIRAPEX® (0.125 mg) | 0 | 9 |
| Total, serious adverse events | MIRAPEX® (0.25 mg) | 0 | 15 |
| Total, serious adverse events | MIRAPEX® (0.5 mg) | 0 | 2 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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