Trial · NCT00601523
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| Secondary | L-Dopa Dose: Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | Change from open-label baseline in Levodopa dose |
| Secondary | Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients | Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636) | Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment |
| Secondary | Patient Preference Regarding Treatment Dosing | 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) | Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing |
| Secondary | Patient Rating of Convenience of Treatment Dosing | 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) | Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT00601523/registered