Skip to main content
OpenTrials
Completed

NCT Number: NCT01100073

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

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.

Completed

Looking for future studies?

Notify Me

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 5, Keila, Estonia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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)

  6. 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)

Secondary outcomes

  1. Final Dose Distribution

    Time frame: Enter Week 0 to weeks 9-16 (Visit 3)

    Final Mirapexin® dose distribution at the end of study

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. Number of Premature Discontinuations

    Time frame: Week 0 to weeks 9-16 (end of study)

    Number of patients discontinuing the study prematurely

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
First posted
Apr 8, 2010
Registry last updated
Apr 11, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.