| Secondary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score | 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 | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Least Squares Mean | Standard Error | UPDRS scores on a scale | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-13.6± 1.3
- OG001-13.3± 1.3
|
|
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| Secondary | Change From Baseline in Percentage Off-time | 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). | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Least Squares Mean | Standard Error | Percentage of off-time | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
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| Secondary | Change From Baseline in Percentage On-time Without Dyskinesia | 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. | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Least Squares Mean | Standard Error | Percentage of on-time | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
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| Secondary | Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia | 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. | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Least Squares Mean | Standard Error | Percentage of on-time | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
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| Secondary | Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia | 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. | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Least Squares Mean | Standard Error | Percentage of on-time | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
| |
| Secondary | Change From Baseline in Percentage On-time With Troublesome Dyskinesia | 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. | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Least Squares Mean | Standard Error | Percentage of on-time | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
| |
| Secondary | Responder Rate For Clinical Global Impression of Improvement (CGI-I) | 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) with last observation carried forward (LOCF) | Posted | | Number | | percentage of participants | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
| |
| Secondary | Responder Rate For Patient Global Impression of Improvement (PGI-I) | 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) | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Number | | percentage of participants | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
| |
| Secondary | Change From Baseline in UPDRS Part I Score | UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Least Squares Mean | Standard Error | UPDRS scores on a scale | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
| |
| Secondary | Change From Baseline in UPDRS Part II Score | 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. | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Least Squares Mean | Standard Error | UPDRS scores on a scale | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
| |
| Secondary | Change From Baseline in UPDRS Part III Score | UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Least Squares Mean | Standard Error | UPDRS scores on a scale | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
| |
| Secondary | Change From Baseline in UPDRS Part IV Score | UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Least Squares Mean | Standard Error | UPDRS scores on a scale | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
| |
| Secondary | UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) | Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Number | | percentage of participants | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
| |
| Secondary | Change From Baseline in L-dopa Daily Dose | The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit. | Full Analysis Set (FAS) with last observation carried forward (LOCF) | Posted | | Least Squares Mean | Standard Error | mg per day | | baseline and after 12 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
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| Primary | Percentage of Participants Who Experienced Adverse Events | An adverse event is defined as any untoward medical occurrence | Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration. | Posted | | Number | | percentage of participants | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
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| Secondary | Trough Plasma Concentration at Steady State | 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. | | Posted | | Geometric Mean | Standard Deviation | ng/ml | | at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pramipexole Immediate Release Group (PPX IR) | 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 |
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| Secondary | Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment | 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 | | Posted | | Mean | Standard Error | ng/mL | | from Visit 1 to Visit 8 after pramipexole ER | Cpre,ss (ng/ml) for Pramipexole (Plasma) | Participants | | ID | Title | Description |
|---|
| OG000 | 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 |
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| Secondary | 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) | 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. | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Least Squares Mean | Standard Error | UPDRS scores on a scale | | Week 12 to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | From PPX ER to 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 | | OG001 | 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 for 12 weeks 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 |
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| Secondary | 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) | 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) | Full Analysis Set (FAS 2) for the open-label period | Posted | | Number | | percentage of participants | | Week 12 to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | From PPX ER to 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 | | OG001 | 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 for 12 weeks 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 |
| |
| Secondary | 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) | 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) | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Number | | percentage of participants | | Week 12 to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | From PPX ER to 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 | | OG001 | 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 |
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| Secondary | 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) | 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). | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Number | | percentage of participants | | Week 12 to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | From PPX ER to 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 | | OG001 | 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 |
| |
| Secondary | Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase) | 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 | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Mean | Standard Deviation | UPDRS scores on a scale | | Baseline and after 64 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole ER: Open-Label Phase | 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 during open label period |
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| Secondary | UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase) | Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Number | | percentage of participants | | baseline and after 64 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole ER: Open-Label Phase | 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 during open-label period |
| |
| Secondary | Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase) | 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). | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Mean | Standard Deviation | Percentage of off-time | | baseline and after 64 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole ER: Open-Label Phase | 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 during open-label period |
| |
| Secondary | Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase) | 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. | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Mean | Standard Deviation | Percentage of on-time | | baseline and after 64 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole ER: Open-Label Phase | 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 during open-label period |
| |
| Secondary | Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase) | 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. | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Mean | Standard Deviation | Percentage of on-time | | baseline and after 64 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole ER: Open-Label Phase | 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 during open-label period |
| |
| Secondary | Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase) | 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. | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Mean | Standard Deviation | Percentage of on-time | | baseline and after 64 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole ER: Open-Label Phase | 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 during open-label period |
| |
| Secondary | Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase) | 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. | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Mean | Standard Deviation | Percentage of on-time | | baseline and after 64 weeks treatment | | | | ID | Title | Description |
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| OG000 | Pramipexole ER: Open-Label Phase | 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 during open-label period |
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| Secondary | Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase) | The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit. | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Mean | Standard Deviation | mg per day | | baseline and after 64 weeks treatment | | | | ID | Title | Description |
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| OG000 | Pramipexole ER: Open-Label Phase | 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 during open-label period |
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| Secondary | Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase) | UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Mean | Standard Deviation | UPDRS scores on a scale | | baseline and after 64 weeks treatment | | | | ID | Title | Description |
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| OG000 | Pramipexole ER: Open-Label Phase | 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 during open-label period |
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| Secondary | Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase) | 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. | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Mean | Standard Deviation | UPDRS scores on a scale | | baseline and after 64 weeks treatment | | | | ID | Title | Description |
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| OG000 | Pramipexole ER: Open-Label Phase | 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 during open-label period |
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| Secondary | Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase) | UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Least Squares Mean | Standard Error | UPDRS scores on a scale | | baseline and after 64 weeks treatment | | | | ID | Title | Description |
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| OG000 | Pramipexole ER: Open-Label Phase | 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 during open-label period |
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| Secondary | Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase) | UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy | Full Analysis Set (FAS 2) for open label period with observed case (OC) | Posted | | Mean | Standard Deviation | UPDRS scores on a scale | | baseline and after 64 weeks treatment | | | | ID | Title | Description |
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| OG000 | Pramipexole ER: Open-Label Phase | 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 during open-label period |
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