Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01525641|
Recruitment Status : Completed
First Posted : February 3, 2012
Results First Posted : August 14, 2015
Last Update Posted : August 14, 2015
|Condition or disease||Intervention/treatment|
|Parkinson Disease||Drug: Mirapex LA|
|Study Type :||Observational|
|Actual Enrollment :||615 participants|
|Official Title:||Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
|Patient with Parkinson's Disease||
Drug: Mirapex LA
Pramipexole Hydrochloride Hydrate
- Percentage of Adverse Drug Reactions [ Time Frame: From baseline up to week 52 ]Percentage of subjects with adverse drug reactions
- Clinical Global Impression of Effect [ Time Frame: Week 52 ]Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect.
- Change From Baseline in Total Score of the UPDRS Part III to Last Observation [ Time Frame: Baseline and week 52 ]
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.
- Change From Baseline in the Modified Hoehn & Yahr to Last Observation [ Time Frame: Baseline and week 52 ]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.
- Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA [ Time Frame: Week 52 ]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".
- Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA [ Time Frame: Week 52 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525641
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|