Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
- Registration Number
- NCT00601523
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 511
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase. Pramipexole Pramipexole Patient to receive Pramipexole ER 0.375-4.5 mg tabl form daily
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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.
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
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
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
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.
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
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
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
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
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
Trial Locations
- Locations (119)
248.633.01004 Boehringer Ingelheim Investigational Site
🇺🇸Sun City, Arizona, United States
248.633.01018 Boehringer Ingelheim Investigational Site
🇺🇸Tempe, Arizona, United States
248.633.01016 Boehringer Ingelheim Investigational Site
🇺🇸La Jolla, California, United States
248.633.01013 Boehringer Ingelheim Investigational Site
🇺🇸Oxnard, California, United States
248.633.01008 Boehringer Ingelheim Investigational Site
🇺🇸Danbury, Connecticut, United States
248.633.01010 Boehringer Ingelheim Investigational Site
🇺🇸Boca Raton, Florida, United States
248.633.01012 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
248.633.01001 Boehringer Ingelheim Investigational Site
🇺🇸Kansas City, Kansas, United States
248.633.01005 Boehringer Ingelheim Investigational Site
🇺🇸Commack, New York, United States
248.633.01009 Boehringer Ingelheim Investigational Site
🇺🇸Burlington, Vermont, United States
Scroll for more (109 remaining)248.633.01004 Boehringer Ingelheim Investigational Site🇺🇸Sun City, Arizona, United States