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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: February 1, 2012
Last updated: July 17, 2015
Last verified: July 2015

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.

Condition Intervention
Parkinson Disease
Drug: Mirapex LA

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of Adverse Drug Reactions [ Time Frame: From baseline up to week 52 ] [ Designated as safety issue: No ]
    Percentage of subjects with adverse drug reactions

Secondary Outcome Measures:
  • Clinical Global Impression of Effect [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

Enrollment: 615
Study Start Date: February 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient with Parkinson's Disease Drug: Mirapex LA
Pramipexole Hydrochloride Hydrate


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population



Inclusion criteria:

- Patients with Parkinson's disease who have never been treated with Mirapex LA Tablets before enrolment will be included.

Exclusion criteria:

- None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01525641

  Show 118 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim Identifier: NCT01525641     History of Changes
Other Study ID Numbers: 248.680
Study First Received: February 1, 2012
Results First Received: June 4, 2015
Last Updated: July 17, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on October 08, 2015