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)
248.633.01016 Boehringer Ingelheim Investigational Site
🇺🇸La Jolla, California, United States
248.633.01013 Boehringer Ingelheim Investigational Site
🇺🇸Oxnard, California, United States
248.633.43004 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
248.633.3303A Boehringer Ingelheim Investigational Site
🇫🇷Aix en Provence, France
248.633.42004 Boehringer Ingelheim Investigational Site
🇨🇿Olomouc, Czech Republic
248.633.3305A Boehringer Ingelheim Investigational Site
🇫🇷Créteil, France
248.633.3304A Boehringer Ingelheim Investigational Site
🇫🇷Evreux, France
248.633.3308A Boehringer Ingelheim Investigational Site
🇫🇷Lille cedex, France
248.633.01005 Boehringer Ingelheim Investigational Site
🇺🇸Commack, New York, United States
248.633.3309B Boehringer Ingelheim Investigational Site
🇫🇷Clermont Ferrand, France
248.633.3302B Boehringer Ingelheim Investigational Site
🇫🇷Marseille cedex 5, France
248.633.3306C Boehringer Ingelheim Investigational Site
🇫🇷Montpellier, France
248.633.3311A Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
248.633.49016 Boehringer Ingelheim Investigational Site
🇩🇪Bochum, Germany
248.633.43001 Boehringer Ingelheim Investigational Site
🇦🇹Innsbruck, Austria
248.633.3308E Boehringer Ingelheim Investigational Site
🇫🇷Lille cedex, France
248.633.3312B Boehringer Ingelheim Investigational Site
🇫🇷Rouen, France
248.633.3301C Boehringer Ingelheim Investigational Site
🇫🇷Toulouse Cedex 7, France
248.633.49005 Boehringer Ingelheim Investigational Site
🇩🇪Bochum, Germany
248.633.36005 Boehringer Ingelheim Investigational Site
🇭🇺Györ, Hungary
248.633.3303C Boehringer Ingelheim Investigational Site
🇫🇷Aix en Provence, France
248.633.49017 Boehringer Ingelheim Investigational Site
🇩🇪Karlsruhe, Germany
248.633.3303B Boehringer Ingelheim Investigational Site
🇫🇷Aix en Provence, France
248.633.3309A Boehringer Ingelheim Investigational Site
🇫🇷Clermont Ferrand, France
248.633.49007 Boehringer Ingelheim Investigational Site
🇩🇪Dresden, Germany
248.633.49018 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
248.633.49019 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
248.633.49001 Boehringer Ingelheim Investigational Site
🇩🇪Kassel, Germany
248.633.49015 Boehringer Ingelheim Investigational Site
🇩🇪Unterhaching, Germany
248.633.3312A Boehringer Ingelheim Investigational Site
🇫🇷Rouen, France
248.633.49012 Boehringer Ingelheim Investigational Site
🇩🇪Leipzig, Germany
248.633.49011 Boehringer Ingelheim Investigational Site
🇩🇪Gera, Germany
248.633.91007 Boehringer Ingelheim Investigational Site
🇮🇳Maharashtra, India
248.633.01018 Boehringer Ingelheim Investigational Site
🇺🇸Tempe, Arizona, United States
248.633.01008 Boehringer Ingelheim Investigational Site
🇺🇸Danbury, Connecticut, 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
248.633.81005 Boehringer Ingelheim Investigational Site
🇯🇵Fuchu, Tokyo, Japan
248.633.01009 Boehringer Ingelheim Investigational Site
🇺🇸Burlington, Vermont, United States
248.633.35802 Boehringer Ingelheim Investigational Site
🇫🇮Tampere, Finland
248.633.3305B Boehringer Ingelheim Investigational Site
🇫🇷Créteil, France
248.633.3313A Boehringer Ingelheim Investigational Site
🇫🇷Dijon cedex, France
248.633.3308B Boehringer Ingelheim Investigational Site
🇫🇷Lille cedex, France
248.633.3308C Boehringer Ingelheim Investigational Site
🇫🇷Lille cedex, France
248.633.3308D Boehringer Ingelheim Investigational Site
🇫🇷Lille cedex, France
248.633.3302A Boehringer Ingelheim Investigational Site
🇫🇷Marseille cedex 5, France
248.633.3302C Boehringer Ingelheim Investigational Site
🇫🇷Marseille cedex 5, France
248.633.3306A Boehringer Ingelheim Investigational Site
🇫🇷Montpellier cédex 5, France
248.633.3306B Boehringer Ingelheim Investigational Site
🇫🇷Montpellier, France
248.633.3306D Boehringer Ingelheim Investigational Site
🇫🇷Montpellier, France
248.633.3306F Boehringer Ingelheim Investigational Site
🇫🇷Montpellier, France
248.633.3311B Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
248.633.3301B Boehringer Ingelheim Investigational Site
🇫🇷Toulouse cedex, France
248.633.3301A Boehringer Ingelheim Investigational Site
🇫🇷Toulouse, France
248.633.3301D Boehringer Ingelheim Investigational Site
🇫🇷Toulouse, France
248.633.3301F Boehringer Ingelheim Investigational Site
🇫🇷Toulouse, France
248.633.01010 Boehringer Ingelheim Investigational Site
🇺🇸Boca Raton, Florida, United States
248.633.49004 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
248.633.49009 Boehringer Ingelheim Investigational Site
🇩🇪Achim bei Bremen, Germany
248.633.49003 Boehringer Ingelheim Investigational Site
🇩🇪Berlin-Steglitz, Germany
248.633.49013 Boehringer Ingelheim Investigational Site
🇩🇪Marburg, Germany
248.633.36008 Boehringer Ingelheim Investigational Site
🇭🇺Miskolc, Hungary
248.633.36004 Boehringer Ingelheim Investigational Site
🇭🇺Sopron, Hungary
248.633.36006 Boehringer Ingelheim Investigational Site
🇭🇺Szeged, Hungary
248.633.36003 Boehringer Ingelheim Investigational Site
🇭🇺Szombathely, Hungary
248.633.36002 Boehringer Ingelheim Investigational Site
🇭🇺Zalaegerszeg, Hungary
248.633.91009 Boehringer Ingelheim Investigational Site
🇮🇳Hyderabad, India
248.633.91002 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
248.633.91004 Boehringer Ingelheim Investigational Site
🇮🇳New Delhi, India
248.633.91011 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
248.633.81010 Boehringer Ingelheim Investigational Site
🇯🇵Aomori, Aomori, Japan
248.633.81011 Boehringer Ingelheim Investigational Site
🇯🇵Fujisawa, Kanagawa, Japan
248.633.81013 Boehringer Ingelheim Investigational Site
🇯🇵Fukuoka, Fukuoka, Japan
248.633.81015 Boehringer Ingelheim Investigational Site
🇯🇵Iwamizawa,Hokkaido, Japan
248.633.81003 Boehringer Ingelheim Investigational Site
🇯🇵Kodaira, Tokyo, Japan
248.633.81014 Boehringer Ingelheim Investigational Site
🇯🇵Kyoto, Kyoto, Japan
248.633.81008 Boehringer Ingelheim Investigational Site
🇯🇵Okayama, Okayama, Japan
248.633.81009 Boehringer Ingelheim Investigational Site
🇯🇵Morioka, Iwate, Japan
248.633.81004 Boehringer Ingelheim Investigational Site
🇯🇵Sagamihara, Kanagawa, Japan
248.633.81007 Boehringer Ingelheim Investigational Site
🇯🇵Shimogyo-ku, Kyoto, Kyoto, Japan
248.633.81002 Boehringer Ingelheim Investigational Site
🇯🇵Takamatsu, Kagawa, Japan
248.633.31002 Boehringer Ingelheim Investigational Site
🇳🇱Geldrop, Netherlands
248.633.81012 Boehringer Ingelheim Investigational Site
🇯🇵Shiroishi, Miyagi, Japan
248.633.31003 Boehringer Ingelheim Investigational Site
🇳🇱Helmond, Netherlands
248.633.31006 Boehringer Ingelheim Investigational Site
🇳🇱Maastricht, Netherlands
248.633.31004 Boehringer Ingelheim Investigational Site
🇳🇱Nijmegen, Netherlands
248.633.31001 Boehringer Ingelheim Investigational Site
🇳🇱Sittard-geleen, Netherlands
248.633.07002 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
248.633.07001 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
248.633.42101 Boehringer Ingelheim Investigational Site
🇸🇰Trnava, Slovakia
248.633.07006 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
248.633.88601 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
248.633.88603 Boehringer Ingelheim Investigational Site
🇨🇳Kaohsiung, Taiwan
248.633.07004 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
248.633.38006 Boehringer Ingelheim Investigational Site
🇺🇦Zaporozhye, Ukraine
248.633.42002 Boehringer Ingelheim Investigational Site
🇨🇿Rychnov nad Kneznou, Czech Republic
248.633.36001 Boehringer Ingelheim Investigational Site
🇭🇺Szeged, Hungary
248.633.91001 Boehringer Ingelheim Investigational Site
🇮🇳Karnataka, India
248.633.81001 Boehringer Ingelheim Investigational Site
🇯🇵Bunkyo-ku, Tokyo, Japan
248.633.81006 Boehringer Ingelheim Investigational Site
🇯🇵Ota-ku, Tokyo, Japan
248.633.38005 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
248.633.07003 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
248.633.42003 Boehringer Ingelheim Investigational Site
🇨🇿Pardubice, Czech Republic
248.633.42001 Boehringer Ingelheim Investigational Site
🇨🇿Praha, Czech Republic
248.633.35803 Boehringer Ingelheim Investigational Site
🇫🇮Hyvinkää, Finland
248.633.35801 Boehringer Ingelheim Investigational Site
🇫🇮Oulu, Finland
248.633.91005 Boehringer Ingelheim Investigational Site
🇮🇳Maharashtra, India
248.633.60004 Boehringer Ingelheim Investigational Site
🇲🇾Kuala Terengganu, Malaysia
248.633.88602 Boehringer Ingelheim Investigational Site
🇨🇳Taoyuan, Taiwan
248.633.38003 Boehringer Ingelheim Investigational Site
🇺🇦Vinnytzya, Ukraine
248.633.01004 Boehringer Ingelheim Investigational Site
🇺🇸Sun City, Arizona, United States
248.633.36007 Boehringer Ingelheim Investigational Site
🇭🇺Eger, Hungary
248.633.38002 Boehringer Ingelheim Investigational Site
🇺🇦Uzhgorod, Ukraine
248.633.38001 Boehringer Ingelheim Investigational Site
🇺🇦Lvov, Ukraine
248.633.42103 Boehringer Ingelheim Investigational Site
🇸🇰Dubnica nad Vahom, Slovakia
248.633.88605 Boehringer Ingelheim Investigational Site
🇨🇳Taichung, Taiwan
248.633.38004 Boehringer Ingelheim Investigational Site
🇺🇦Zaporizhzhya, Ukraine
248.633.49002 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
248.633.3301G Boehringer Ingelheim Investigational Site
🇫🇷Toulouse, France