| Primary | Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15 | The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) | The Phase 2 Full Analysis Set (FAS2) was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.3± 0.7
- OG0010.7± 0.7
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.6503 | | Mean Difference (Net) | -0.4 | Standard Error of the Mean | 0.9 | | 95 | -2.2 | 1.4 | | | | No | Superiority or Other | | |
|
| Secondary | Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15 | The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9 | The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6 | The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3 | The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15 | The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15 | The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9 | The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6 | The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3 | The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15 | The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15 | The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9 | The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6 | The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3 | The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15 | The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15 | The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9 | The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6 | The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3 | The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15 | The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15 | The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9 | The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6 | The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3 | The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15 | The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 27 patients from the FAS2 were excluded due to insufficient CGI-I data. | Posted | | Number | | Participants | | Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15 | The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (>1 category improvement), 'Unchanged' or 'Worsened' (>1 category worsening). | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 4 patients from the FAS2 were excluded due to insufficient CGI-I data. | Posted | | Number | | Participants | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15 | The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient BDI data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9 | The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6 | The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3 | The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15 | The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. | Posted | | Median | Inter-Quartile Range | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9 | The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data. | Posted | | Median | Inter-Quartile Range | Units on a scale | | Baseline and Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15 | The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data. | Posted | | Median | Inter-Quartile Range | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9 | The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data. | Posted | | Median | Inter-Quartile Range | Units on a scale | | Baseline and Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
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| Secondary | Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15 | The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data. | Posted | | Median | Inter-Quartile Range | Units on a scale | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
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| Secondary | Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9 | The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state) | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 5 patients from the FAS2 were excluded due to insufficient efficacy data. | Posted | | Median | Inter-Quartile Range | Units on a scale | | Baseline and Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
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| Secondary | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
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| Secondary | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
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| Secondary | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
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| Secondary | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
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| Secondary | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
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| Secondary | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
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| Secondary | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
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| Secondary | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
| |
| Secondary | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. | The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data. | Posted | | Number | | Participants | | Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
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| Secondary | Percentage Change From Baseline in the Striatum Uptake at Month 15 | The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT). | The substudy set was made up of all randomised patients with a baseline and end of treatment assessment of striatal uptake. | Posted | | Least Squares Mean | Standard Error | Percentage change | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | 1.5 milligrams/day pramipexole (for up to 15 months) | | OG001 | Delayed Pramipexole | Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) |
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| Secondary | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | | Treated set: Haematocrit and mean corpuscular volume (MCV-N) was 211 for Early PPX and 209 for Delayed PPX, Haemoglobin-N was 213 for Early PPX and 212 for Delayed PPX, Sodium-N was 211 for Early PPX and 209 for Delayed PPX, Calcium and Chloride-N was 214 for Early PPX and 209 for Delayed PPX, Phosphate-N was 201 for Early and Delayed PPX | Posted | | Number | | percentage of participants | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study. | | OG001 | Delayed Pramipexole | Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study. |
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| Secondary | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes | | Gamma Glutamyltranspeptidase (GGT-N) was 214 for Early PPX and 208 for Delayed PPX, Amylase-N was 214 for Early PPX and 209 for Delayed PPX | Posted | | Number | | percentage of participants | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study. | | OG001 | Delayed Pramipexole | Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study. |
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| Secondary | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | | Glucose-N was 28 for Early PPX and 46 for Delayed PPX, Cholesterol and Triglyceride-N was 213 for Early PPX and 208 for Delayed PPX, Blood Urea Nitrogen-N was 214 for Early PPX and 209 for Delayed PPX, Creatinine-N was 200 for Early PPX and 202 for Delayed PPX, Uric Acid-N was 212 for Early PPX and 209 for Delayed PPX. | Posted | | Number | | percentage of participants | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study. | | OG001 | Delayed Pramipexole | Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study. |
| |
| Secondary | Clinically Significant Abnormalities in Vital Signs | | Phase 1 Treated set for sinus bradycardia with N of 261 for Early PPX and 274 for Delayed PPX. Phase 2 Treated set for hypotension with N of 221 for Early PPX and 214 for Delayed PPX. | Posted | | Number | | percentage of participants | | Baseline and Month 15 | | | | ID | Title | Description |
|---|
| OG000 | Early Pramipexole | Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study. | | OG001 | Delayed Pramipexole | Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study. |
| |