Trial Outcomes & Findings for A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period (NCT NCT00560508)

Results Overview

An adverse event is defined as any untoward medical occurrence

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

112 participants

Primary outcome timeframe

12 weeks

Results posted on

2014-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	Pramipexole Extended Release Group (PPX ER) Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	Pramipexole Immediate Release Group (PPX IR) Pramipexole Immediate Release (IR) tablets of 0.125 mg and 0.5 mg dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
12 Week Double-blind Period STARTED	56	56
12 Week Double-blind Period COMPLETED	51	53
12 Week Double-blind Period NOT COMPLETED	5	3
52-week Open-label Period Pramipexole ER STARTED	51	53
52-week Open-label Period Pramipexole ER COMPLETED	43	42
52-week Open-label Period Pramipexole ER NOT COMPLETED	8	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Pramipexole Extended Release Group (PPX ER) Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	Pramipexole Immediate Release Group (PPX IR) Pramipexole Immediate Release (IR) tablets of 0.125 mg and 0.5 mg dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
12 Week Double-blind Period Adverse Event	3	2
12 Week Double-blind Period Protocol Violation	1	0
12 Week Double-blind Period Withdrawal by Subject	1	1
52-week Open-label Period Pramipexole ER Adverse Event	6	6
52-week Open-label Period Pramipexole ER Lack of Efficacy	1	1
52-week Open-label Period Pramipexole ER Withdrawal by Subject	0	3
52-week Open-label Period Pramipexole ER Other reason - investigator's judgement	1	1

Baseline Characteristics

A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pramipexole Extended Release Group (PPX ER) n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	Pramipexole Immediate Release Group (PPX IR) n=56 Participants Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day	Total n=112 Participants Total of all reporting groups
Age, Continuous	68.8 years STANDARD_DEVIATION 8.0 • n=5 Participants	66.1 years STANDARD_DEVIATION 7.5 • n=7 Participants	67.5 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration.

An adverse event is defined as any untoward medical occurrence

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Percentage of Participants Who Experienced Adverse Events	83.93 percentage of participants	83.93 percentage of participants

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score	-13.3 UPDRS scores on a scale Standard Error 1.3	-13.6 UPDRS scores on a scale Standard Error 1.3

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

Percentage off-time during waking hours in the last two days 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).

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in Percentage Off-time	-7.8 Percentage of off-time Standard Error 2.4	-5.8 Percentage of off-time Standard Error 2.4

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

Percentage on-time without dyskinesia during waking hours in the last two days 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.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in Percentage On-time Without Dyskinesia	7.0 Percentage of on-time Standard Error 2.5	6.4 Percentage of on-time Standard Error 2.5

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days 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.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia	0.1 Percentage of on-time Standard Error 0.4	-0.4 Percentage of on-time Standard Error 0.4

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days 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.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia	7.1 Percentage of on-time Standard Error 2.5	6.0 Percentage of on-time Standard Error 2.5

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

Percentage on-time with troublesome dyskinesia during waking hours in the last two days 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.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in Percentage On-time With Troublesome Dyskinesia	0.5 Percentage of on-time Standard Error 0.5	-0.1 Percentage of on-time Standard Error 0.5

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

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)

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Responder Rate For Clinical Global Impression of Improvement (CGI-I)	50.0 percentage of participants	48.2 percentage of participants

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

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

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Responder Rate For Patient Global Impression of Improvement (PGI-I)	33.9 percentage of participants	33.9 percentage of participants

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

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

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in UPDRS Part I Score	-0.2 UPDRS scores on a scale Standard Error 0.2	0.1 UPDRS scores on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

UPDRS Part 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.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in UPDRS Part II Score	-3.4 UPDRS scores on a scale Standard Error 0.4	-3.3 UPDRS scores on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

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

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in UPDRS Part III Score	-9.9 UPDRS scores on a scale Standard Error 1.0	-10.2 UPDRS scores on a scale Standard Error 1.0

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

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

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in UPDRS Part IV Score	-0.4 UPDRS scores on a scale Standard Error 0.2	-0.2 UPDRS scores on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)	82.1 percentage of participants	78.6 percentage of participants

SECONDARY outcome

Timeframe: baseline and after 12 weeks treatment

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF)

The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=56 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=56 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in L-dopa Daily Dose	-1.8 mg per day Standard Error 3.0	-5.3 mg per day Standard Error 3.0

SECONDARY outcome

Timeframe: at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment

Population: Full Analysis Set (FAS)

Geometric mean (gMean) was calculated for trough plasma concentrations of pramipexole at steady state after administration of pramipexole IR 4.5mg and pramipexole ER 4.5mg.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=30 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=24 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Trough Plasma Concentration at Steady State	5.09 ng/ml Standard Deviation 2.53	5.46 ng/ml Standard Deviation 2.01

SECONDARY outcome

Timeframe: from Visit 1 to Visit 8 after pramipexole ER

Population: Full Analysis Set (FAS).

Dose proportionality of trough plasma concentrations at steady state is explored by using the power model that described the functional relationship between the dose and plasma concentration

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=195 Cpre,ss (ng/ml) for Pramipexole (Plasma) Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment	—	1.0375 ng/mL Standard Error 0.0177

SECONDARY outcome

Timeframe: Week 12 to Week 16

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms. Least square means and standard errors presented are from ANCOVA with factors treatment and covariate baseline.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=53 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=50 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)	-0.2 UPDRS scores on a scale Standard Error 0.6	-2.2 UPDRS scores on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: Week 12 to Week 16

Population: Full Analysis Set (FAS 2) for the open-label period

Percentage of patients with no worsening of UPDRS Parts II+III Total Score by more than 15% from week 12 to week 16 (Open-label: Dose Adjustment Phase)

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=53 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=51 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)	83.0 percentage of participants	78.4 percentage of participants

SECONDARY outcome

Timeframe: Week 12 to Week 16

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

Clinical Global Impression of Improvement (CGI-I) at week 16 compared to patient's CGI-I status at week 12. CGI-I scores ranging from '1' (very much improved) to '7' (very much worse)

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=53 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=50 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) Very much improved	1.9 percentage of participants	0.0 percentage of participants
Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) Much improved	5.7 percentage of participants	8.0 percentage of participants
Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) Minimally improved	35.8 percentage of participants	48.0 percentage of participants
Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) No change	50.9 percentage of participants	34.0 percentage of participants
Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) Minimally worse	5.7 percentage of participants	10.0 percentage of participants

SECONDARY outcome

Timeframe: Week 12 to Week 16

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

Patient Global Impression of Improvement (PGI-I) at week 16 compared to patient's PGI-I status at week 12. PGI-I scores ranging from '1' (very much better) to '7' (very much worse).

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER n=53 Participants From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=50 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) Very much better	3.8 percentage of participants	2.0 percentage of participants
Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) Much better	11.3 percentage of participants	14.0 percentage of participants
Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) A little better	35.8 percentage of participants	36.0 percentage of participants
Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) No change	39.6 percentage of participants	36.0 percentage of participants
Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) A little worse	9.4 percentage of participants	12.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and after 64 weeks treatment

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=87 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)	—	-15.2 UPDRS scores on a scale Standard Deviation 11.1

SECONDARY outcome

Timeframe: baseline and after 64 weeks treatment

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=87 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)	—	92.0 percentage of participants

SECONDARY outcome

Timeframe: baseline and after 64 weeks treatment

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

Percentage off-time during waking hours in the last two days 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).

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=87 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)	—	-11.6 Percentage of off-time Standard Deviation 22.1

SECONDARY outcome

Timeframe: baseline and after 64 weeks treatment

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

Percentage on-time without dyskinesia during waking hours in the last two days 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.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=87 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)	—	11.9 Percentage of on-time Standard Deviation 21.1

SECONDARY outcome

Timeframe: baseline and after 64 weeks treatment

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days 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.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=87 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)	—	-0.1 Percentage of on-time Standard Deviation 5.7

SECONDARY outcome

Timeframe: baseline and after 64 weeks treatment

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days 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.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=87 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)	—	11.8 Percentage of on-time Standard Deviation 21.6

SECONDARY outcome

Timeframe: baseline and after 64 weeks treatment

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

Percentage on-time with troublesome dyskinesia during waking hours in the last two days 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.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=87 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)	—	-0.2 Percentage of on-time Standard Deviation 2.8

SECONDARY outcome

Timeframe: baseline and after 64 weeks treatment

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=87 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)	—	10.3 mg per day Standard Deviation 62.0

SECONDARY outcome

Timeframe: baseline and after 64 weeks treatment

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

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

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=87 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)	—	-0.3 UPDRS scores on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: baseline and after 64 weeks treatment

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

UPDRS Part 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.

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=87 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)	—	-3.4 UPDRS scores on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: baseline and after 64 weeks treatment

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

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

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=87 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)	—	-11.9 UPDRS scores on a scale Standard Error 8.2

SECONDARY outcome

Timeframe: baseline and after 64 weeks treatment

Population: Full Analysis Set (FAS 2) for open label period with observed case (OC)

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

Outcome measures

Outcome measures
Measure	From PPX IR to PPX ER From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	From PPX ER to PPX ER n=87 Participants Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)	—	-0.6 UPDRS scores on a scale Standard Deviation 1.6

Adverse Events

Pramipexole Extended Release Group (PPX ER)

Serious events: 12 serious events

Other events: 52 other events

Deaths: 0 deaths

Pramipexole Immediate Release Group (PPX IR)

Serious events: 10 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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

Measure	Pramipexole Extended Release Group (PPX ER) n=56 participants at risk Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	Pramipexole Immediate Release Group (PPX IR) n=56 participants at risk Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
Infections and infestations Pneumonia	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Infections and infestations Pyelonephritis	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Blood and lymphatic system disorders Disseminated intravascular coagulation	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Metabolism and nutrition disorders Dehydration	3.6% 2/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Psychiatric disorders Delusion	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Psychiatric disorders Hallucination, visual	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Nervous system disorders Parkinson's disease	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	3.6% 2/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Nervous system disorders Chronic inflammatory polyradiculoneuropathy	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Nervous system disorders Dyskinesia	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Nervous system disorders Parkinsonism	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Eye disorders Cataract	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Eye disorders Retinal detachment	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Cardiac disorders Atrial fibrillation	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Cardiac disorders Sick sinus syndrome	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Gastrointestinal disorders Inguinal hernia	3.6% 2/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Musculoskeletal and connective tissue disorders Posture abnormal	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	3.6% 2/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Musculoskeletal and connective tissue disorders Back pain	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Renal and urinary disorders Urinary retention	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Injury, poisoning and procedural complications Spinal compression fracture	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).

Measure	Pramipexole Extended Release Group (PPX ER) n=56 participants at risk Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day	Pramipexole Immediate Release Group (PPX IR) n=56 participants at risk Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
Injury, poisoning and procedural complications Spinal compression fracture	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Infections and infestations Nasopharyngitis	32.1% 18/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	32.1% 18/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Metabolism and nutrition disorders Decreased appetite	7.1% 4/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	7.1% 4/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Metabolism and nutrition disorders Dehydration	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	3.6% 2/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Psychiatric disorders Hallucination, visual	12.5% 7/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	12.5% 7/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Psychiatric disorders Insomnia	7.1% 4/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	7.1% 4/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Psychiatric disorders Delirium	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Nervous system disorders Somnolence	37.5% 21/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	35.7% 20/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Nervous system disorders Dyskinesia	16.1% 9/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	7.1% 4/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Nervous system disorders Dizziness	14.3% 8/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	7.1% 4/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Nervous system disorders Dizziness postural	8.9% 5/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Nervous system disorders Sudden onset of sleep	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	3.6% 2/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Eye disorders Asthenopia	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Vascular disorders Orthostatic hypotension	12.5% 7/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	8.9% 5/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Vascular disorders Hypotension	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	7.1% 4/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Gastrointestinal disorders Constipation	12.5% 7/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	21.4% 12/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Gastrointestinal disorders Nausea	14.3% 8/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	17.9% 10/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Gastrointestinal disorders Stomatitis	10.7% 6/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Gastrointestinal disorders Dental caries	7.1% 4/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	3.6% 2/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Gastrointestinal disorders Vomiting	7.1% 4/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Gastrointestinal disorders Gastritis	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Gastrointestinal disorders Reflux oesophagitis	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Skin and subcutaneous tissue disorders Eczema	7.1% 4/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Skin and subcutaneous tissue disorders Rash	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Musculoskeletal and connective tissue disorders Back pain	14.3% 8/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	19.6% 11/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Musculoskeletal and connective tissue disorders Pain in extremity	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	8.9% 5/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	7.1% 4/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	7.1% 4/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	0.00% 0/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Musculoskeletal and connective tissue disorders Osteoporosis	3.6% 2/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
General disorders Oedema peripheral	12.5% 7/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Injury, poisoning and procedural complications Fall	12.5% 7/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	17.9% 10/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Injury, poisoning and procedural complications Contusion	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).
Injury, poisoning and procedural complications Excoriation	1.8% 1/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).	5.4% 3/56 • From the first dose of trial medication onwards through the observational phase (64 weeks).