Trial · NCT00601523
Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
NCT00601523, Phase 3, Completed, Boehringer Ingelheim; results first posted 2011-08-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD). Trials, record NCT00601523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00601523
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
- NCT number
- NCT00601523
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 511 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Parkinson Disease
- Interventions
- Placebo, Pramipexole
- First posted
- 2008-01-28
- Last updated
- 2014-06-09
- Other registries' IDs
- eudract:2007-004234-16
- Results first posted
- 2011-08-25
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) | The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation |
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline | Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms |
| Secondary | Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636) | OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | A response means an improvement of \>=20% from OL baseline. UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms |
| Secondary | UPDRS I Total Score: Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood |
| Secondary | UPDRS II Total Score: Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living. |
| Secondary | UPDRS III Total Score: Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms |
| Secondary | Response in Clinical Global Impression of Improvement (CGI-I) | OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636) | Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders |
| Secondary | Response in Patient Global Impression of Improvement (PGI-I) | OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636) | Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders |
| Secondary | Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | PFS-16 ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD. |
| Secondary | Number of Patients Introducing L-Dopa Medication in OL Trial | 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) | Number of patients requiring Levodopa supplementation during the study |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline | Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636) | Units of scale | MEAN |
| SECONDARY | Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636) | OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636) | Patients | NUMBER |
| SECONDARY | UPDRS I Total Score: Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | Patients from FAS and who had values for UPDRS I at week 80 (patients from 248.524) or at week 72 (patients from 248.636) | Units of scale | MEAN |
| SECONDARY | UPDRS II Total Score: Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | Patients from FAS and who had values for UPDRS II at week 80 (patients from 248.524) or at week 72 (patients from 248.636) | Units of scale | MEAN |
| SECONDARY | UPDRS III Total Score: Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | Patients from FAS and who had values for UPDRS III at week 80 (patients from 248.524) or at week 72 (patients from 248.636) | Units of scale | MEAN |
| SECONDARY | Response in Clinical Global Impression of Improvement (CGI-I) | OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636) | Patients from FAS and who had values for for CGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636) | Patients | NUMBER |
| SECONDARY | Response in Patient Global Impression of Improvement (PGI-I) | OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636) | Patients from FAS and who had values for for PGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636) | Patients | NUMBER |
| SECONDARY | Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | Patients from FAS and who had values for PFS-16 at week 80 (patients from 248.524) or at week 72 (patients from 248.636) | Units of scale | MEAN |
| SECONDARY | Number of Patients Introducing L-Dopa Medication in OL Trial | 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) | Patients from FAS | Patients | NUMBER |
| SECONDARY | L-Dopa Dose: Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | Patients from FAS and with L-Dopa at OL baseline and at week 80 (patients from 248.524) or week 72 (patients from 248.636) | Patients | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline | Patients From 248.524 | 2.2 | Standard Deviation 9.5 | Units of scale | |
| Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline | Patients From 248.636 | 1.5 | Standard Deviation 7.7 | Units of scale | |
| Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636) | Patients From 248.524 | 73 | Patients | ||
| Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636) | Patients From 248.636 | 27 | Patients | ||
| UPDRS I Total Score: Change From OL Baseline | Patients From 248.524 | 0.3 | Standard Deviation 1.0 | Units of scale | |
| UPDRS I Total Score: Change From OL Baseline | Patients From 248.636 | 0.1 | Standard Deviation 1.3 | Units of scale | |
| UPDRS II Total Score: Change From OL Baseline | Patients From 248.524 | 1.0 | Standard Deviation 3.2 | Units of scale | |
| UPDRS II Total Score: Change From OL Baseline | Patients From 248.636 | 0.6 | Standard Deviation 3.5 | Units of scale | |
| UPDRS III Total Score: Change From OL Baseline | Patients From 248.524 | 1.1 | Standard Deviation 7.2 | Units of scale | |
| UPDRS III Total Score: Change From OL Baseline | Patients From 248.636 | 0.9 | Standard Deviation 5.6 | Units of scale |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients From 248.524 | 368 | |
| Overall Study | STARTED | Patients From 248.636 | 143 | |
| Overall Study | COMPLETED | Patients From 248.524 | 291 | |
| Overall Study | COMPLETED | Patients From 248.636 | 117 | |
| Overall Study | NOT COMPLETED | Patients From 248.524 | 77 | |
| Overall Study | NOT COMPLETED | Patients From 248.636 | 26 |
Source ClinicalTrials.gov
Adverse events184
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 | Cataract | Eye disorders | Patients From 248.524 | 25 | 368 | |
| other | Cataract | Eye disorders | Patients From 248.636 | 7 | 143 | |
| other | Constipation | Gastrointestinal disorders | Patients From 248.524 | 15 | 368 | |
| other | Constipation | Gastrointestinal disorders | Patients From 248.636 | 9 | 143 | |
| other | Nausea | Gastrointestinal disorders | Patients From 248.524 | 37 | 368 | |
| other | Nausea | Gastrointestinal disorders | Patients From 248.636 | 10 | 143 | |
| other | Oedema peripheral | General disorders | Patients From 248.524 | 45 | 368 | |
| other | Oedema peripheral | General disorders | Patients From 248.636 | 15 | 143 | |
| other | Nasopharyngitis | Infections and infestations | Patients From 248.524 | 29 | 368 | |
| other | Nasopharyngitis | Infections and infestations | Patients From 248.636 | 8 | 143 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients From 248.524 | ||
| Total, all-cause mortality | Patients From 248.636 | ||
| Total, other adverse events | Patients From 248.524 | 214 | 368 |
| Total, other adverse events | Patients From 248.636 | 62 | 143 |
| Total, serious adverse events | Patients From 248.524 | 53 | 368 |
| Total, serious adverse events | Patients From 248.636 | 21 | 143 |
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 |
|---|
| Patients From 248.524 vs Patients From 248.636: 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/NCT00601523
GET https://conductscience.org/api/trials/v1/NCT00601523/results?page=2