Pivotal Study in Advanced Parkinsons Disease Patients | NCT00466167

Label	Type	Intervention Names
Pramipexole ER	Other	Drug: Pramipexol Extended Release
Pramipexole IR	Other	Drug: Pramipexol Immediate Release
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Pramipexol Extended Release	Drug		Pramipexole ER
Pramipexol Immediate Release

Measure	Description	Time Frame
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18	UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms	baseline and week 18

Measure	Description	Time Frame
Change From Baseline in Percentage Off-time at Week 18	Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).	baseline and week 18

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
248.525.43005 Boehringer Ingelheim Investigational Site		Linz			Austria
248.525.42003 Boehringer Ingelheim Investigational Site

ID	Title	Description
FG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
FG001	Pramipexole IR

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) Parts II+III Score at Week 18

UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

Full analysis set (FAS 1) population = 507 patients FAS 1 defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication, were treated for 18 weeks (or had prematurely discontinued treatment prior to week 18) and provided baseline and any on-drug post-baseline efficacy assessment

Posted

Least Squares Mean

Standard Error

Percentage of change from baseline

baseline and week 18

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Units	Counts
Participants	OG000161 OG001172 OG002174

Title

Denominators

Categories

Title	Measurements
	OG000-11.0± 1.0 OG001-12.8± 0.9 OG002-6.1± 0.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	ANCOVA with factors treatment, pooled country and covariate baseline	ANCOVA		0.0001		Adjusted mean difference from placebo	4.9	Standard Error of the Mean	1.3	2-Sided	95	2.4	7.4				No	Superiority or Other
OG001 OG002	ANCOVA with factors treatment, pooled country and covariate baseline

Secondary

Change From Baseline in Percentage Off-time at Week 18

Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Percentage of off-time

baseline and week 18

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Change From Baseline in Percentage On-time Without Dyskinesia at Week 18

Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Percentage of on-time without dyskinesia

baseline and week 18

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18

Percentage on-time with non-troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Percentage of on-time

baseline and week 18

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18

Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Percentage of on-time

baseline and week 18

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Clinical Global Impression - Global Improvement (CGI-I) Responder

CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Number

Participants

after 18 weeks of treatment

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Response in Patient Global Impression (PGI-I)

PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring 1 or 2 (at least much better)

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Number

Participants

after 18 weeks of treatment

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Change From Baseline in UPDRS I Score After 18 Weeks

UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Median

Inter-Quartile Range

Units on a scale

baseline and 18 weeks

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period

UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities.

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Units on a scale

baseline and 18 weeks

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Change From Baseline in UPDRS III Score After 18 Weeks

UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Units on a scale

baseline and 18 weeks

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Change From Baseline in UPDRS IV Score After 18 Weeks

UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Units on a scale

baseline and 18 weeks

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks

ranging from 0 (best case) to 63 (worst case)

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Units on a scale

baseline and 18 weeks

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks

ranging from 0 (worst case) to 150 (best case)

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Units on a scale

baseline and 18 weeks

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks

Ranging from 0 (best case) to 156 (worst case)

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Units on a scale

baseline and 18 weeks

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks

ranging from 0 (worst case) to 100 (best case)

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Units on a scale

baseline and 18 weeks

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18

Likert scale is a method used for the measurement of pain. The patients were asked to rate their pain related to PD by ticking the number that best described their pain on the average in the previous week, from zero for "no pain" to ten for "unbearable pain".

Full analysis set (FAS 1) population with last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

units on a scale

baseline and week 18

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Secondary

Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)

Treated set (TS 1) population: defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication and were treated for 18 weeks (or had discontinued treatment prior to week 18). Data limited to visit 8 (or V11 in case of premature discontinuation before visit 8).

Posted

Number

participants

baseline and week 18

ID	Title	Description
OG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
OG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
OG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0011 affected164 at risk EG0020 affected175 at risk
Pneumonia	Infections and infestations	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Post viral fatigue syndrome	Infections and infestations	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Sepsis	Infections and infestations	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Dehydration	Metabolism and nutrition disorders	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Hypokalaemia	Metabolism and nutrition disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Hallucination, visual	Psychiatric disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0012 affected164 at risk EG0020 affected175 at risk
Insomnia	Psychiatric disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0022 affected175 at risk
Agitation	Psychiatric disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Delirium	Psychiatric disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Delusion	Psychiatric disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0011 affected164 at risk EG0021 affected175 at risk
Depression	Psychiatric disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Hallucination	Psychiatric disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Psychotic disorder	Psychiatric disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Suicide attempt	Psychiatric disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Dementia	Nervous system disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Depressed level of consciousness	Nervous system disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0011 affected164 at risk EG0020 affected175 at risk
Disturbance in attention	Nervous system disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0011 affected164 at risk EG0020 affected175 at risk
On and off phenomenon	Nervous system disorders	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Peripheral sensory neuropathy	Nervous system disorders	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Presyncope	Nervous system disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0011 affected164 at risk EG0020 affected175 at risk
Radiculpathy	Nervous system disorders	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Syncope	Nervous system disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Arrhythmia	Cardiac disorders	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Atrial fibrillation	Cardiac disorders	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Cardiopulmonary failure	Cardiac disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Hypotension	Vascular disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0011 affected164 at risk EG0020 affected175 at risk
Orthostatic hypotension	Vascular disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0011 affected164 at risk EG0020 affected175 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0011 affected164 at risk EG0020 affected175 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Diarrhoea	Gastrointestinal disorders	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Dysphagia	Gastrointestinal disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Renal failure chronic	Renal and urinary disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Uterine prolapse	Reproductive system and breast disorders	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Chest pain	General disorders	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0011 affected164 at risk EG0020 affected175 at risk
Fall	Injury, poisoning and procedural complications	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0022 affected175 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Femur fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Fibula fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Forearm fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0011 affected164 at risk EG0020 affected175 at risk
Hip fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Ligament injury	Injury, poisoning and procedural complications	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Overdose	Injury, poisoning and procedural complications	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Peripheral nerve injury	Injury, poisoning and procedural complications	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Tendon injury	Injury, poisoning and procedural complications	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk
Tibia fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected164 at risk EG0021 affected175 at risk
Medical device change	Surgical and medical procedures	MEDDRA 11.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected164 at risk EG0020 affected175 at risk

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

ID	Term
D052160	Benzothiazoles
D013844	Thiazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
BG001	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
BG002	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning	15	178	74	178
EG001	Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning	8	164	73	164
EG002	Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"	11	175	90	175

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MEDDRA 11.1	Systematic Assessment	EG00012 affected178 at risk EG0013 affected164 at risk EG0027 affected175 at risk
Anorexia	Metabolism and nutrition disorders	MEDDRA 11.1	Systematic Assessment	EG0004 affected178 at risk EG0019 affected164 at risk EG0022 affected175 at risk
Hallucination	Psychiatric disorders	MEDDRA 11.1	Systematic Assessment	EG0002 affected178 at risk EG0019 affected164 at risk EG00210 affected175 at risk
Insomnia	Psychiatric disorders	MEDDRA 11.1	Systematic Assessment	EG0004 affected178 at risk EG0019 affected164 at risk EG0026 affected175 at risk
Dyskinesia	Nervous system disorders	MEDDRA 11.1	Systematic Assessment	EG00016 affected178 at risk EG00128 affected164 at risk EG00234 affected175 at risk
Somnolence	Nervous system disorders	MEDDRA 11.1	Systematic Assessment	EG00029 affected178 at risk EG00124 affected164 at risk EG00230 affected175 at risk
Dizziness	Nervous system disorders	MEDDRA 11.1	Systematic Assessment	EG0009 affected178 at risk EG0019 affected164 at risk EG00219 affected175 at risk
Headache	Nervous system disorders	MEDDRA 11.1	Systematic Assessment	EG0005 affected178 at risk EG00114 affected164 at risk EG0029 affected175 at risk
Nausea	Gastrointestinal disorders	MEDDRA 11.1	Systematic Assessment	EG00019 affected178 at risk EG00118 affected164 at risk EG00220 affected175 at risk
Constipation	Gastrointestinal disorders	MEDDRA 11.1	Systematic Assessment	EG0009 affected178 at risk EG00111 affected164 at risk EG00210 affected175 at risk
Vomiting	Gastrointestinal disorders	MEDDRA 11.1	Systematic Assessment	EG0005 affected178 at risk EG0012 affected164 at risk EG00210 affected175 at risk