Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

Completed

Conditions: Parkinson Disease

Interventions: Drug: Mirapex LA

Registration Number: NCT01525641

Lead Sponsor: Boehringer Ingelheim

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 615

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with Parkinson's Disease	Mirapex LA	-

Primary Outcome Measures

Name	Time	Method
Percentage of Adverse Drug Reactions	From baseline up to week 52	Percentage of subjects with adverse drug reactions

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Modified Hoehn & Yahr to Last Observation	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	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".
Clinical Global Impression of Effect	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	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.
Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA	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.

Trial Locations

Locations (118): Boehringer Ingelheim Investigational Site 28
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Abiko,Chiba, Japan
Boehringer Ingelheim Investigational Site 86
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Akashi,Hyogo, Japan
Boehringer Ingelheim Investigational Site 13
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Akita,Akita, Japan
Boehringer Ingelheim Investigational Site 9
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Aomori,Aomori, Japan
Boehringer Ingelheim Investigational Site 2
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Asahikawa,Hokkaido, Japan
Boehringer Ingelheim Investigational Site 36
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Bunkyo,Tokyo, Japan
Boehringer Ingelheim Investigational Site 35
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Chuo,Tokyo, Japan
Boehringer Ingelheim Investigational Site 40
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Chuo,Tokyo, Japan
Boehringer Ingelheim Investigational Site 54
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Chuo,Yamanashi, Japan
Boehringer Ingelheim Investigational Site 6
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Date,Hokkaido, Japan
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Boehringer Ingelheim Investigational Site 28
🇯🇵Abiko,Chiba, Japan