| Primary | Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF) | A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment) | Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint | Posted | | Number | | Percentage of participants | | from baseline to week 9 | | | | ID | Title | Description |
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| OG000 | Pramipexole Extended Release (ER) | 0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os | | OG001 | Pramipexole Immediate Release (IR) | 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os |
| | | Title | Denominators | Categories |
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| Successfully switched | | | | Not successfully switched | | |
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| Secondary | Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF) | A successful switch was defined by no change of the UPDRS II+III by more than 15% from baseline to week 4, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment). | Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint | Posted | | Number | | Percentage of participants | | from baseline to week 4 | | | | ID | Title | Description |
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| OG000 | Pramipexole Extended Release (ER) | 0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os | | OG001 | Pramipexole Immediate Release (IR) | 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os |
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| Secondary | Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF) | Unified Parkinson's Disease Rating Scale part II+III total score on FAS, Week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment) | Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint | Posted | | Least Squares Mean | Standard Error | Score on scale | | Baseline and week 9 | | | | ID | Title | Description |
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| OG000 | Pramipexole Extended Release (ER) | 0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os | | OG001 | Pramipexole Immediate Release (IR) | 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os |
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| Secondary | Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF) | Unified Parkinson's Disease Rating Scale part II total score on FAS, Week 9 - baseline, UPDRS II score ranging from 0 (no impairment) to 52 (worst impairment) | Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint | Posted | | Mean | Standard Error | Score on Scale | | Baseline and week 9 | | | | ID | Title | Description |
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| OG000 | Pramipexole Extended Release (ER) | 0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os | | OG001 | Pramipexole Immediate Release (IR) | 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os |
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| Secondary | Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF) | Unified Parkinson's Disease Rating Scale part III total score on FAS, week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 108 (worst impairment) | Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint | Posted | | Least Squares Mean | Standard Error | Score on Scale | | Baseline and week 9 | | | | ID | Title | Description |
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| OG000 | Pramipexole Extended Release (ER) | 0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os | | OG001 | Pramipexole Immediate Release (IR) | 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os |
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| Secondary | Clinical Global Impression - Improvement (CGI-I), FAS (LOCF) | Clinical Global Impression - Improvement on FAS, CGI-I was rated from 1: very much improved, to 7: very much worse, CGI-I responder are defined as being rated as 'unchanged', 'minimally improved', 'much improved', or 'very much improved', CGI-I non-responder are defined as being rated 'minimally worse', 'much worse' or 'very much worse' | Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint | Posted | | Number | | participants | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pramipexole Extended Release (ER) | 0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os | | OG001 | Pramipexole Immediate Release (IR) | 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os |
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| Secondary | Patient Global Impression - Improvement (PGI-I), FAS (LOCF) | Patient Global Impression - Improvement on FAS, PGI-I was rated from 1: very much better, to 7: very much worse, PGI-I responder are defined as being rated as 'unchanged', 'minimally better', 'much better', or 'very much better', PGI-I non-responder are defined as being rated as 'minimally worse', 'much worse', or 'very much worse' | Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint | Posted | | Number | | participants | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pramipexole Extended Release (ER) | 0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os | | OG001 | Pramipexole Immediate Release (IR) | 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os |
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| Secondary | Pramipexole Dose Adaptation, FAS (LOCF) | Patients with increase in daily Pramipexole dose on FAS | Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint | Posted | | Number | | participants | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pramipexole Extended Release (ER) | 0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os | | OG001 | Pramipexole Immediate Release (IR) | 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os |
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| Secondary | Final Pramipexole Dose (mg) After 9 Weeks, Treated Set | The mean final daily Pramipexole dose is displayed | Treated Set (TS) includes all patients randomized and who received treatment | Posted | | Mean | Standard Deviation | mg | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pramipexole Extended Release (ER) | 0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os | | OG001 | Pramipexole Immediate Release (IR) | 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os |
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