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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT01100073
Date of registration:	18/03/2010
Prospective Registration:	No
Primary sponsor:	Boehringer Ingelheim
Public title:	Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
Scientific title:	Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
Date of first enrolment:	February 2008
Target sample size:	1703
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01100073
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Estonia	Latvia	Romania	Russian Federation	Serbia	Slovakia	Slovenia	Ukraine

Contacts

Name:	Boehringer Ingelheim
Address:
Telephone:
Email:
Affiliation:	Boehringer Ingelheim

Key inclusion & exclusion 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®)

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Primary Outcome(s)

Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand) [Time Frame: Week 0 to weeks 9-16 (Visit 3)]

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 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 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 From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand) [Time Frame: Week 0 to weeks 9-16 (Visit 3)]

Change From Baseline in UPDRS Part III Score at the End of Maintenance [Time Frame: Week 0 to weeks 9-16]

Secondary Outcome(s)

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)]

Incidence, Relationship and Seriousness of Adverse Events [Time Frame: Week 0 to weeks 9-16 (end of study)]

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)]

Number of Premature Discontinuations [Time Frame: Week 0 to weeks 9-16 (end of study)]

Final Dose Distribution [Time Frame: Enter Week 0 to weeks 9-16 (Visit 3)]

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)]

Secondary ID(s)

248.657

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	20/09/2010
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01100073

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