| Secondary | Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III | Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score >20 without a relative worsening of UPDRS II+III score > 15% from baseline or UPDRS II+III baseline score <=20 without an absolute worsening of UPDRS II+III score > 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms | Patients from Full Analysis Set (FAS included all patients who were dispensed study medication, had received at least one dose of study drug and had provided any post-baseline efficacy assessment) and who maintain the final dose of the previous study | Posted | | Number | | Patients | | One week | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG001 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| | | Title | Denominators | Categories |
|---|
| | |
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| Secondary | UPDRS II+III Change From Open Label (OL) Baseline | UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms | Patients from FAS with values of UPDRS II+III at week 80 | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | OL Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
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| Secondary | Number of Participants With UPDRS II+III Response | A response means an improvement of >=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms | Patients from FAS with values of UPDRS II+III at week 80 | Posted | | Number | | Patients | | Week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time | A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). | Patients from FAS and who maintain the final dose of the previous study | Posted | | Number | | Patients | | One week | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG001 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
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| Secondary | Percentage Off Time During Waking Hours Total Score: Change From Baseline | 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). A negative change implies improvement | Patients from FAS with values of UPDRS II+III at week 80 | Posted | | Least Squares Mean | Standard Error | percentage during waking hours | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
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| Secondary | Number of Participants With Response in Percentage Off Time During Waking Hours | Response means >=20% improvement relative to OL baseline in the % off-time during waking hours | Patients from FAS with values of off time during waking hours at 80 weeks | Posted | | Number | | Patients | | 80 weeks | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial | | OG003 | Total PPX ER | Pramipexole ER, all patients |
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| Secondary | Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | 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. A positive change implies improvement. | Patients from FAS with values of on time during waking hours at week 80 | Posted | | Least Squares Mean | Standard Error | percentage during waking hours | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | 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. A positive change implies improvement | Patients from FAS with values of on time during waking hours at week 80 | Posted | | Least Squares Mean | Standard Error | percentage during waking hours | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
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| Secondary | Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | Percentage on-time without dyskinesia or 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. A positive change implies improvement | Patients from FAS with values of on time during waking hours at week 80 | Posted | | Least Squares Mean | Standard Error | percentage during waking hours | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | Percentage on-time with 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. A positive change implies improvement | Patients from FAS with values of on time during waking hours at week 80 | Posted | | Least Squares Mean | Standard Error | percentage during waking hours | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Number of Participants With Response in CGI-I | Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders | Patients from FAS with values of CGI-I at week 32 | Posted | | Number | | Patients | | 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial | | OG003 | Total PPX ER | Pramipexole ER, all patients |
| |
| Secondary | Number of Participants With Response in PGI-I | Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders | Patients from FAS with values of PGI-I at week 32 | Posted | | Number | | Patients | | 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial | | OG003 | Total PPX ER | Pramipexole ER, all patients |
| |
| Secondary | Number of Participants With Response in PGI-I for Early Morning Off Symptoms | Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders | Patients from FAS with values of PGI-I for early morning off symptoms at week 32 | Posted | | Number | | Patients | | 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial | | OG003 | Total PPX ER | Pramipexole ER, all patients |
|
| Secondary | UPDRS I Total Score and Change From OL Baseline at Week 80 | UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood | Patients from FAS with values of UPDRS I at week 80 | Posted | | Least Squares Mean | Standard Error | units on a scale | | OL baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | UPDRS II Total Score and Change From OL Baseline at Week 80 | 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 | Patients from FAS with values of UPDRS II at week 80 | Posted | | Least Squares Mean | Standard Error | units on a scale | | OL baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | UPDRS III Total Score and Change From OL Baseline at Week 80 | UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms | Patients from FAS with values of UPDRS III at week 80 | Posted | | Least Squares Mean | Standard Error | units on a scale | | OL baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | UPDRS IV Total Score and Change From OL Baseline at Week 80 | UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy | Patients from FAS with values of UPDRS IV at week 80 | Posted | | Least Squares Mean | Standard Error | Unit on a scale | | OL baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80 | PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD | Patients from FAS with values of PFS-16 score at week 80 | Posted | | Least Squares Mean | Standard Error | Unit on a scale | | OL baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | | Patients from FAS with documentation of levodopa (L-DOPA) daily dose at week 80 | Posted | | Number | | Patients | | OL baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial | | OG003 | Total PPX ER | Pramipexole ER, all patients |
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| Secondary | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | | Patients from Treated Set (all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80 | Posted | | Number | | Patients | | OL baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial | | OG003 | Total PPX ER | Pramipexole ER, all patients |
| |
| Secondary | Number of Participants With Serious Adverse Events | | The Treated Set (TS) included all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment | Posted | | Number | | Patients | | 80 weeks | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial | | OG003 | Total PPX ER | Pramipexole ER, all patients |
| |
| Primary | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation. | Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) | Posted | | Number | | Percentage of participants | | 80 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Treatment with matching placebo in previous trial (NCT00466167) | | OG001 | PPX ER | Treatment with Pramipexole ER in previous trial | | OG002 | PPX IR | Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | | Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data | Posted | | Mean | Standard Deviation | mm Hg | | OL Baseline and Week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | | Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data | Posted | | Mean | Standard Deviation | mm Hg | | OL Baseline and Week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | | Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data | Posted | | Mean | Standard Deviation | mm Hg | | OL Baseline and Week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | | Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data | Posted | | Mean | Standard Deviation | mm Hg | | OL Baseline and Week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | | Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data | Posted | | Mean | Standard Deviation | beats per minute | | OL Baseline and Week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | | Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data | Posted | | Mean | Standard Deviation | beats per minute | | OL Baseline and Week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set | | Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data | Posted | | Mean | Standard Deviation | kg | | OL Baseline and Week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set | | Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data | Posted | | Mean | Standard Deviation | kg | | OL Baseline and Week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set | ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing) | | Posted | | Mean | Standard Deviation | units on a scale | | OL Baseline and Week 80 | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |
| Secondary | Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set | The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral. | Treated Set - all patients dispensed drug and documented to have taken at least one dose | Posted | | Number | | participants | | Baseline, 80 weeks | | | | ID | Title | Description |
|---|
| OG000 | PPX ER (Previous Placebo) | Pramipexole ER Treatment with placebo in previous trial | | OG001 | PPX ER (Previous PPX ER) | Pramipexole ER Treatment with Pramipexole ER in previous trial | | OG002 | PPX ER (Previous PPX IR) | Pramipexole ER Treatment with Pramipexole IR in previous trial |
| |