First Presentation of Parkinson Disease Patients to Neuro... | NCT00802178

NCT00802178

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

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Arms/Interventions Module

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Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated	Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor. De-novo patients were identified by: those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy)	4 - 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I	Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)	Baseline and 4 to 8 weeks
Change From Baseline in UPDRS Part III

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		Bjelovar			Croatia
Boehringer Ingelheim Investigational Site

References Module

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IPD Sharing Statement Module

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Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Mirapexin® (Pramipexole)	The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of administration (admin.): Tablets for oral use

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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Condition Browse Module

Intervention Browse Module

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Masking Info

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Arm/Group Information

ID	Title	Description
BG000	Mirapexin® (Pramipexole)	The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Female

Title	Measurements
	BG0001145

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

Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated

Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.

De-novo patients were identified by:

those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy)

Full Analysis set (FAS) of De-novo patients in whom monotherapy with Mirapexin® could be successfully initiated

Posted

Number

Participants

4 - 8 weeks

ID	Title	Description
OG000	Mirapexin® (Pramipexole)	The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.

Units	Counts
Participants	OG000833

Title

Denominators

Categories

Very good

Title	Measurements
	OG000403

Good

Title	Measurements
	OG000323

Moderate

Secondary

Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I

Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)

Full Analysis set (FAS)

Posted

Number

Unit on a scale

Baseline and 4 to 8 weeks

ID	Title	Description
OG000	Mirapexin® (Pramipexole)	The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in UPDRS Part III

Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability).

Full Analysis set (FAS)

Posted

Number

Unit on a scale

Baseline and 4 - 8 weeks

ID	Title	Description
OG000	Mirapexin® (Pramipexole)	The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.

Units	Counts
Participants	OG000

Secondary

Global Clinical Assessments of Efficacy of Mirapexin® for All Patients

Treated set (TS)

Posted

Number

Number of Participants

4 - 8 weeks

ID	Title	Description
OG000	Mirapexin® (Pramipexole)	The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.

Units	Counts
Participants	OG000

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)	The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.			0	2,448	0	2,448

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