| Secondary | Mean Change From Baseline in Total Tic Score (TTS) 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. | The Full Analysis Set (FAS) with last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | 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 (FAS) with Last Observation Carried Forward (LOCF). | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 24 (end of treatment visit) | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) 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. | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) 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. | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) 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. | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 3 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) 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. | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) 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. | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) 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. | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) 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. | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) 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. | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) 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. | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 3 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Clinical Global Impressions - Severity of Illness | 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 (FAS) with last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | score on a scale | | week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Clinical Global Impressions - Severity of Illness, Categorized | Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (among the most extremely ill patients). 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 (FAS) with last observation carried forward (LOCF). | Posted | | Number | | participants | | week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Clinical Global Impressions - Improvement | Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 1 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Clinical Global Impressions - Improvement | Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 2 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Primary | Patients With Adverse Events Leading to Discontinuation of Trial Drug | Number of patients with Adverse Events leading to discontinuation of trial drug | | Posted | | Number | | participants | | 24 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Clinical Global Impressions - Improvement | Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 3 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Clinical Global Impressions - Improvement | Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Clinical Global Impressions - Improvement | Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 8 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Clinical Global Impressions - Improvement | Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 12 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Clinical Global Impressions - Improvement | Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 16 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Clinical Global Impressions - Improvement | Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 20 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Clinical Global Impressions - Improvement | Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse). | The Full Analysis Set (FAS) with last observation carried forward (LOCF). | Posted | | Number | | participants | | week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Patient Global Impression - Improvement | 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). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 1 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Patient Global Impression - Improvement | 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). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 2 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Patient Global Impression - Improvement | 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). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 3 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Patient Global Impression - Improvement | 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). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Patient Global Impression - Improvement | 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). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 8 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Patient Global Impression - Improvement | 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). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 12 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Patient Global Impression - Improvement | 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). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 16 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
| |
| Secondary | Patient Global Impression - Improvement | 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). | This outcome measure was not analyzed due to the premature ending of the trial. | Posted | | | | | | week 20 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
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| Secondary | Patient Global Impression - Improvement | 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 (FAS) with last observation carried forward (LOCF). | Posted | | Number | | participants | | week 24 | | | | ID | Title | Description |
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| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
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| Secondary | Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters | Frequency of patients with possible clinically significant abnormalities for laboratory parameters (blood hematology and electrolyte assessments, serum chemistry, including follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol for pubertal female patients, prolactin in all patients, testosterone in pubertal male patients, urine analysis) | Observed Cases Treated set (OC TS). All participants in Treated Set having observed data at the particular timepoint. | Posted | | Number | | participants | | Baseline and 24 weeks | | | | ID | Title | Description |
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| OG000 | Pramipexole | 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. |
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