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Completed

NCT Number: NCT01525641

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 28, Abiko,Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Mirapex LA

Drug

Pramipexole Hydrochloride Hydrate

Primary outcomes

  1. Percentage of Adverse Drug Reactions

    Time frame: From baseline up to week 52

    Percentage of subjects with adverse drug reactions

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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".

  5. 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2012
Registry last updated
Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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