Kinetic Tremor in Parkinsons Disease: Its Course Under Pr... | NCT01100073

NCT01100073

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Patients with Parkinson's disease		Early and advanced Parkinson's disease patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance	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)	Week 0 to weeks 9-16 (Visit 3)
Change From Baseline in UPDRS Part III Score at the End of Maintenance	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)	Week 0 to weeks 9-16
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)	Change (reduction) in tremor amplitude from baseline to end of study for the right hand	Week 0 to weeks 9-16 (Visit 3)
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)	Change (reduction) in tremor amplitude from baseline to end of study for the left hand	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)	Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)	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	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

Measure	Description	Time Frame
Final Dose Distribution	Final Mirapexin® dose distribution at the end of study	Enter Week 0 to weeks 9-16 (Visit 3)
Change From Baseline in UPDRS Part II Score at the End of Up-titration	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)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site 5		Keila			Estonia
Boehringer Ingelheim Investigational Site 4

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

No data available

No data is available for this block.

FG0001699 subjectsBaseline (Visit 1)

Treated set (TS) (31 patients were missing age and 17 patients were missing gender)

Arm/Group Information

ID	Title	Description
BG000	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.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00066.4± 9.70

Sex/Gender, Customized

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG000844

Male

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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)

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

Posted

Mean

Standard Deviation

Points on UPDRS scale

Week 0 to weeks 9-16 (Visit 3)

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG0001424

Title

Denominators

Categories

Title	Measurements
	OG0005.20± 4.5

Primary

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

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)

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

Posted

Mean

Standard Deviation

Points on UPDRS scale

Week 0 to weeks 9-16

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Primary

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

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

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

Posted

Mean

Standard Deviation

millimeters of tremor amplitude

Week 0 to weeks 9-16 (Visit 3)

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Primary

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

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

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

Posted

Mean

Standard Deviation

millimeters of tremor amplitude

Week 0 to weeks 9-16 (Visit 3)

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Primary

Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)

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

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

Posted

Mean

Standard Deviation

Points on UPDRS scale

Week 0 to weeks 9-16 (Visit 3)

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Primary

Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance

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)

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

Posted

Mean

Standard Deviation

unit on a scale

Week 0 to weeks 9-16 (Visit 3)

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Final Dose Distribution

Final Mirapexin® dose distribution at the end of study

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

Posted

Median

Full Range

milligrams of Mirapexin® (salt)

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

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in UPDRS Part II Score at the End of Up-titration

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)

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

Posted

Mean

Standard Deviation

Points on a UPDRS scale

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

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in UPDRS Part III Score at the End of Up-titration

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)

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

Posted

Mean

Standard Deviation

Points on a UPDRS scale

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

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration

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)

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

Posted

Mean

Standard Deviation

Points on a UPDRS scale

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

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Incidence, Relationship and Seriousness of Adverse Events

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

Total patients

Posted

Number

Number of events

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

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Number of Premature Discontinuations

Number of patients discontinuing the study prematurely

Total patients

Posted

Number

Participants

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

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG0001699

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			3	1,699	0	1,699

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertebral Fracture	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,699 at risk
Acute Stroke	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,699 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,699 at risk

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases

Title

Denominators

Categories

Title	Measurements
	OG000100