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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01100073
First received: March 18, 2010
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition
Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Final Dose Distribution [ Time Frame: Enter Week 0 to weeks 9-16 (Visit 3) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    Number of patients discontinuating the study prematurely


Enrollment: 1703
Study Start Date: February 2008
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Parkinson's disease
Early and advanced Parkinson's disease patients

  Eligibility

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

Neurologists

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®)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100073

  Show 215 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01100073     History of Changes
Other Study ID Numbers: 248.657
Study First Received: March 18, 2010
Results First Received: July 30, 2010
Last Updated: May 18, 2012
Health Authority: Estonia: The State Agency of Medicine
Latvia: State Agency of Medicines
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexol
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 21, 2013