| Primary | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. Analysis was adjusted for baseline total tic score and age as linear covariates. | The Full Analysis Set (FAS) with last observation carried forward (LOCF). | Posted | | Least Squares Mean | Standard Error | score on a scale | | baseline 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-7.17± 2.02
- OG001-7.16± 1.38
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| | 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 | | 0.996 | | Least Squares mean difference | 0.01 | | | 2-Sided | 95 | -4.95 | 4.97 | | | | No | Superiority or Other | | |
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| Secondary | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1 | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50 | The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients. | Posted | | Mean | Standard Deviation | score on a scale | | baseline 1 week | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2 | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50 | The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients. | Posted | | Mean | Standard Deviation | score on a scale | | baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3 | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50 | The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients. | Posted | | Mean | Standard Deviation | score on a scale | | baseline and 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4 | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50 | The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients. | Posted | | Mean | Standard Deviation | score on a scale | | baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6 | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Least Squares Mean | Standard Error | score on a scale | | baseline and 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1 | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) | The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients. | Posted | | Mean | Standard Deviation | score on a scale | | baseline 1 week | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2 | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) | The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients. | Posted | | Mean | Standard Deviation | score on a scale | | baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3 | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) | The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients. | Posted | | Mean | Standard Deviation | score on a scale | | baseline and 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4 | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) | The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients. | Posted | | Mean | Standard Deviation | score on a scale | | baseline 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Clinical Global Impressions - Improvement at 1 Week | Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement. | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Clinical Global Impressions - Improvement at Week 2 | Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement. | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Clinical Global Impressions - Improvement at Week 3 | Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement. | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 3 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Clinical Global Impressions - Improvement at Week 4 | Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement. | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Clinical Global Impressions - Improvement at Week 6 | Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement. | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Clinical Global Impressions - Severity of Illness at Week 1 | Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater. | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Clinical Global Impressions - Severity of Illness at Week 2 | Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater. | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Clinical Global Impressions - Severity of Illness at Week 3 | Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater. | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 3 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Clinical Global Impressions - Severity of Illness at Week 4 | Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater. | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Clinical Global Impressions - Severity of Illness at Week 6 | Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater. | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Patient Global Impression at Week 1 | Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2). | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Patient Global Impression at Week 2 | Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2). | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Patient Global Impression at Week 3 | Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2). | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 3 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Patient Global Impression at Week 4 | Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2). | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Patient Global Impression at Week 6 | Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2). | The Full Analysis Set with last observation carried forward (LOCF). | Posted | | Number | | Number of Patients | | baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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| Secondary | Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry. | | | Posted | | Number | | participants | | baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablets matching the Pramipexole tablets to be taken per os | | OG001 | Pramipexole | Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. |
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