Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.
Study Type
OBSERVATIONAL
Enrollment
615
Pramipexole Hydrochloride Hydrate
Percentage of Adverse Drug Reactions
Percentage of subjects with adverse drug reactions
Time frame: From baseline up to week 52
Clinical Global Impression of Effect
Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect.
Time frame: Week 52
Change From Baseline in Total Score of the UPDRS Part III to Last Observation
Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score. UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status. The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities. The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia.
Time frame: Baseline and week 52
Change From Baseline in the Modified Hoehn & Yahr to Last Observation
Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement.
Time frame: Baseline and week 52
Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA
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Boehringer Ingelheim Investigational Site 28
Abiko,Chiba, Japan
Boehringer Ingelheim Investigational Site 86
Akashi,Hyogo, Japan
Boehringer Ingelheim Investigational Site 13
Akita,Akita, Japan
Boehringer Ingelheim Investigational Site 9
Aomori,Aomori, Japan
Boehringer Ingelheim Investigational Site 2
Asahikawa,Hokkaido, Japan
Boehringer Ingelheim Investigational Site 36
Bunkyo,Tokyo, Japan
Boehringer Ingelheim Investigational Site 35
Chuo,Tokyo, Japan
Boehringer Ingelheim Investigational Site 40
Chuo,Tokyo, Japan
Boehringer Ingelheim Investigational Site 54
Chuo,Yamanashi, Japan
Boehringer Ingelheim Investigational Site 6
Date,Hokkaido, Japan
...and 108 more locations
Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - "on" - to a sudden inability to move - "off".
Time frame: Week 52
Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA
Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication.
Time frame: Week 52