CompletedNot Applicable

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

Estonia, Latvia, Romania1,703 participantsStarted 2008-02

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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®)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance

Timeframe: Week 0 to weeks 9-16 (Visit 3)

Change From Baseline in UPDRS Part III Score at the End of Maintenance

Timeframe: Week 0 to weeks 9-16

Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)

Timeframe: Week 0 to weeks 9-16 (Visit 3)

Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)

Timeframe: 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)

Timeframe: 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

Timeframe: Week 0 to weeks 9-16 (Visit 3)

Trial details

NCT IDNCT01100073

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2009-08

Results submitted2010-07-30

View on ClinicalTrials.gov More Parkinson Disease trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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®)

What they're measuring

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance

Timeframe: Week 0 to weeks 9-16 (Visit 3)

Change From Baseline in UPDRS Part III Score at the End of Maintenance

Timeframe: Week 0 to weeks 9-16

Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)

Timeframe: Week 0 to weeks 9-16 (Visit 3)

Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)

Timeframe: 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)

Timeframe: 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

Timeframe: Week 0 to weeks 9-16 (Visit 3)