Trial Outcomes & Findings for Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life (NCT NCT01100073)

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

1703 participants

Primary outcome timeframe

Week 0 to weeks 9-16 (Visit 3)

Results posted on

2014-04-11

Participant Flow

* enrolled in study: 1703 * treated (received Mirapexin): 1699 (i.e. 4 patients no record of receiving treatment) * completed study: 1599 (i.e. 100 discontinued prematurely)

Participant milestones

Participant milestones
Measure	Mirapexin® (Pramipexole) Mirapexin® (Pramipexole) - tablets for oral use. The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Study STARTED	1699
Overall Study COMPLETED	1599
Overall Study NOT COMPLETED	100

Reasons for withdrawal

Reasons for withdrawal
Measure	Mirapexin® (Pramipexole) Mirapexin® (Pramipexole) - tablets for oral use. The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Study Lack of Efficacy	4
Overall Study Insufficient Tolerability	21
Overall Study Withdrawal by Subject	13
Overall Study Lost to Follow-up	39
Overall Study Lack of effect + patient's wish	2
Overall Study Insufficient tolerability +patients wish	8
Overall Study Other	8
Overall Study Missing	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mirapexin® (Pramipexole) n=1699 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Age, Continuous	66.4 years STANDARD_DEVIATION 9.70 • n=5 Participants
Sex/Gender, Customized Female	844 participants n=5 Participants
Sex/Gender, Customized Male	838 participants n=5 Participants
Sex/Gender, Customized Category title missing	17 participants n=5 Participants

PRIMARY outcome

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

Population: Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part II scores available

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)

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=1424 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance	5.20 Points on UPDRS scale Standard Deviation 4.5

PRIMARY outcome

Timeframe: Week 0 to weeks 9-16

Population: Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part III scores available

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)

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=1094 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Change From Baseline in UPDRS Part III Score at the End of Maintenance	12 Points on UPDRS scale Standard Deviation 9.9

PRIMARY outcome

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

Population: Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (right hand) available

Change (reduction) in tremor amplitude from baseline to end of study for the right hand

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=949 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)	0.3 millimeters of tremor amplitude Standard Deviation 1.6

PRIMARY outcome

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

Population: Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (left hand) available

Change (reduction) in tremor amplitude from baseline to end of study for the left hand

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=962 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)	0.2 millimeters of tremor amplitude Standard Deviation 1.7

PRIMARY outcome

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

Population: Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS tremor score (UPDRS items 16, 20, 21) available

Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=1169 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)	4.1 Points on UPDRS scale Standard Deviation 3.4

PRIMARY outcome

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

Population: Full analysis set (FAS) - Patients for whom baseline and end of study PDQ-39 score available

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)

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=1239 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance	15 unit on a scale Standard Deviation 18.4

SECONDARY outcome

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

Population: Total patients. Number of participants analysed differs for each outcome measure because not all evaluations were performed / documented on every patient.

Final Mirapexin® dose distribution at the end of study

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=1623 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Final Dose Distribution	3.0 milligrams of Mirapexin® (salt) Interval 0.25 to 7.5

SECONDARY outcome

Timeframe: Enter Week 0 to weeks 1-8 (Visit 2)

Population: Patients for whom baseline and Visit 2 UPDRS Part II scores available

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)

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=1490 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Change From Baseline in UPDRS Part II Score at the End of Up-titration	3.1 Points on a UPDRS scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: Enter Week 0 to weeks 1-8 (Visit 2)

Population: Patients for whom baseline and Visit 2 UPDRS Part III scores available

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)

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=1131 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Change From Baseline in UPDRS Part III Score at the End of Up-titration	7.6 Points on a UPDRS scale Standard Deviation 8.1

SECONDARY outcome

Timeframe: Enter Week 0 to weeks 1-8 (Visit 2)

Population: Patients for whom baseline and Visit 2 UPDRS Part II and III scores available

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)

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=1207 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration	2.5 Points on a UPDRS scale Standard Deviation 2.9

SECONDARY outcome

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

Population: Total patients

Total number of adverse events (AEs), causality and level of seriousness

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=1699 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Incidence, Relationship and Seriousness of Adverse Events Incidence (Total number of AEs)	266 Number of events
Incidence, Relationship and Seriousness of Adverse Events Related (Number of treatment related AEs)	230 Number of events
Incidence, Relationship and Seriousness of Adverse Events SAE (Number of serious adverse events)	3 Number of events

SECONDARY outcome

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

Population: Total patients

Number of patients discontinuing the study prematurely

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=1699 Participants Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Number of Premature Discontinuations	100 Participants

Adverse Events

Mirapexin® (Pramipexole)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mirapexin® (Pramipexole) n=1699 participants at risk Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Musculoskeletal and connective tissue disorders Vertebral Fracture	0.06% 1/1699 • Number of events 1 • Up to 16 weeks
Nervous system disorders Acute Stroke	0.06% 1/1699 • Number of events 1 • Up to 16 weeks
Cardiac disorders Myocardial Infarction	0.06% 1/1699 • Number of events 1 • Up to 16 weeks

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract
Publication restrictions are in place

Restriction type: OTHER