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

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ClinicalTrials.gov Identifier: NCT01100073
Recruitment Status : Completed
First Posted : April 8, 2010
Results First Posted : September 20, 2010
Last Update Posted : April 11, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date March 18, 2010
First Posted Date April 8, 2010
Results First Submitted Date July 30, 2010
Results First Posted Date September 20, 2010
Last Update Posted Date April 11, 2014
Study Start Date February 2008
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 30, 2010)
  • Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance [ Time Frame: 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 UPDRS Part III Score at the End of Maintenance [ Time Frame: 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 Spiralometry Measurement at the End of Maintenance (Right Hand) [ Time Frame: 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 Spiralometry Measurement at the End of Maintenance (Left Hand) [ Time Frame: 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 Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3) [ Time Frame: 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)
  • Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance [ Time Frame: 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)
Original Primary Outcome Measures
 (submitted: April 7, 2010)
  • - Change from baseline in UPDRS (Unified Parkinsons Disease Rating Scale) Part II and Part III score at the end of maintenance (Visit 3) [ Time Frame: Week 0 to weeks 9-19 ]
  • - Change from baseline in spiralometry measurement at the end of maintenance (Visit 3) [ Time Frame: Week 0 to weeks 9-19 ]
  • - Change from baseline in tremor score from UPDRS at the end of maintenance (Visit 3) [ Time Frame: Week 0 to weeks 9-19 ]
  • - Change from baseline in PDQ-39 score at the end of maintenance (Visit 3) [ Time Frame: Week 0 to weeks 9-19 ]
Change History Complete list of historical versions of study NCT01100073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 14, 2014)
  • Final Dose Distribution [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
  • Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration [ Time Frame: 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)
  • Incidence, Relationship and Seriousness of Adverse Events [ Time Frame: Week 0 to weeks 9-16 (end of study) ]
    Total number of adverse events (AEs), causality and level of seriousness
  • Number of Premature Discontinuations [ Time Frame: Week 0 to weeks 9-16 (end of study) ]
    Number of patients discontinuing the study prematurely
Original Secondary Outcome Measures
 (submitted: April 7, 2010)
  • - Final dose distribution [ Time Frame: Week 0 to week 1-8 ]
  • - Change from baseline in UPDRS Part II and Part III score at the end of up-titration (Visit 2) [ Time Frame: Week 0 to week 1-8 ]
  • - Change in tremor score (UPDRS items 16, 20, 21) at the end of up-titration (Visit 2) [ Time Frame: Week 0 to week 1-8 ]
  • - Incidence, relationship and seriousness of adverse events [ Time Frame: Week 0 to week 9-16 ]
  • - Number of premature discontinuations [ Time Frame: Week 0 to week 9-16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
Official Title Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Neurologists
Condition Parkinson Disease
Intervention Not Provided
Study Groups/Cohorts Patients with Parkinson's disease
Early and advanced Parkinson's disease patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 7, 2010)
1703
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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®)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Estonia,   Latvia,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number NCT01100073
Other Study ID Numbers 248.657
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date March 2014