Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT01100073
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The study will compare the effect of pramipexole on different types of tremor and particularly kinetic tremor in early and advanced Parkinson's disease patients and will evaluate the course of tremor measured with spiralometry under pramipexole treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2009-08
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-08
• Results First Submitted: 2010-07-30
• Results First Submitted QC: 2010-08-30
• Results First Posted: 2010-09-20
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-14
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1703

Inclusion Criteria

1. Idiopathic Parkinson's disease with or without fluctuations
2. Indication for treatment with pramipexole (Mirapexin®)
3. Presence of at least mild tremor symptoms (as judged by the treating physician)

Exclusion Criteria

1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
2. Ongoing treatment with pramipexole (Mirapexin®)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance	Week 0 to weeks 9-16 (Visit 3)	Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)	Week 0 to weeks 9-16 (Visit 3)	Change (reduction) in tremor amplitude from baseline to end of study for the left hand
Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance	Week 0 to weeks 9-16 (Visit 3)	Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study. Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure)
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)	Week 0 to weeks 9-16 (Visit 3)	Change (reduction) in tremor amplitude from baseline to end of study for the right hand
Change From Baseline in UPDRS Part III Score at the End of Maintenance	Week 0 to weeks 9-16	Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)	Week 0 to weeks 9-16 (Visit 3)	Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)

Secondary Outcome Measures

Name	Time	Method
Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration	Enter Week 0 to weeks 1-8 (Visit 2)	Change (reduction) from baseline in tremor score, derived from UPDRS from baseline to Visit 2. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
Final Dose Distribution	Enter Week 0 to weeks 9-16 (Visit 3)	Final Mirapexin® dose distribution at the end of study
Change From Baseline in UPDRS Part II Score at the End of Up-titration	Enter Week 0 to weeks 1-8 (Visit 2)	Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to Visit 2. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
Change From Baseline in UPDRS Part III Score at the End of Up-titration	Enter Week 0 to weeks 1-8 (Visit 2)	Change (reduction) in UPDRS Part III score (motor function) from baseline to Visit 2. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
Number of Premature Discontinuations	Week 0 to weeks 9-16 (end of study)	Number of patients discontinuing the study prematurely
Incidence, Relationship and Seriousness of Adverse Events	Week 0 to weeks 9-16 (end of study)	Total number of adverse events (AEs), causality and level of seriousness

Trial Locations

Locations (215)

Boehringer Ingelheim Investigational Site 5; 🇪🇪 Keila, Estonia

Boehringer Ingelheim Investigational Site 4; 🇪🇪 Kohtla-Järve, Estonia

Boehringer Ingelheim Investigational Site 6; 🇪🇪 Rakvere, Estonia

Boehringer Ingelheim Investigational Site 1; 🇪🇪 Tallinn, Estonia

Boehringer Ingelheim Investigational Site 2; 🇪🇪 Tallinn, Estonia

Boehringer Ingelheim Investigational Site 3; 🇪🇪 Tallinn, Estonia

Boehringer Ingelheim Investigational Site 7; 🇪🇪 Tartu, Estonia

Boehringer Ingelheim Investigational Site 8; 🇪🇪 Valga, Estonia

Boehringer Ingelheim Investigational Site 9; 🇱🇻 Kuldiga, Latvia

Boehringer Ingelheim Investigational Site 12; 🇱🇻 Liepaja, Latvia

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