| Primary | Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks | IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms) | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-13.7± 0.8
- OG001-11.1± 0.8
|
|
| | 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 |
|---|
| Analysis of covariance for changes from baseline with factors treatment and country and using baseline as covariate | ANCOVA | | 0.0077 | | Mean Difference (Net) | -2.6 | Standard Error of the Mean | 1 | | 95 | -4.6 | -0.7 | | | | No | Superiority or Other | | |
|
| Secondary | Clinical Global Impression - Global Improvement (CGI-I) Responder Rate | CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring 1 or 2 (at least much improved) | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values. | Posted | | Number | | participants | | after 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate | IRLS response was defined as at least 50% reduction in IRLS total score from baseline. IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe symptoms) | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Number | | participants | | after 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Patient Global Impression (PGI) Responder Rate | PGI scores ranging from '1' (very much better) to '7' (very much worse), PGI responder have scoring 1 or 2 (at least much better) | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Number | | participants | | after 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score "Satisfaction With Sleep" After 26 Weeks | The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | baseline and 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in RLS-6 Score "Severity Falling Asleep" After 26 Weeks | The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in RLS-6 Score "Severity During the Night" After 26 Weeks | The question was rated on an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | baseline and 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in RLS-6 Score "Severity During the Day When at Rest" After 26 Weeks | The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline RLS-6 Score "Severity During the Day Engaged in Activities" After 26 Weeks | The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in RLS-6 Score "Tired or Sleepy During the Day" After 26 Weeks | The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks | Mood disturbance associated with RLS symptoms ranging from 0 (none) to 4 (very severe) | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | scores on a scale | | Baseline and 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks | The scale measures pain on a continuous 100 mm axis ranging from no pain (0 mm) to unbearable pain (100 mm) | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks | RLS QoL total score ranging from 0 to 100 with higher values indicating better quality of life | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks | Score ranging from 0 to 100 with higher scores indicating less bodily pain | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in SF-36 Dimension General Health After 26 Weeks | Score ranging from 0 to 100 with higher scores indicating better health status | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks | Score ranging from 0 to 100 with higher scores indicating better mental health | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks | Score ranging from 0 to 100 with higher scores indicating better physical functioning | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks | Score ranging from 0 to 100 with higher scores indicating less limitations due to emotional problems | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks | Score ranging from 0 to 100 with higher scores indicating less limitations due to physical problems | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks | Score ranging from 0 to 100 with higher scores indicating better social functioning | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in SF-36 Dimension Vitality After 26 Weeks | Score ranging from 0 to 100 with higher scores indicating better vitality | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks | Score ranging from 0 to 100 with higher scores indicating better health | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks | Score ranging from 0 to 100 with higher scores indicating better health | Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values | Posted | | Median | Inter-Quartile Range | Scores on a scale | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Diagnosis of Classified Augmentation According to Independent Expert Panel | Augmentation is a worsening of RLS symptoms and may manifest as increased severity and the involvement of other extremities or as a shift of RLS symptoms to a time period that is 2 or more hours earlier than was typical of the time of symptom onset during the initial course of beneficial stable treatment or the state before recently starting treatment. | Treated Set and where patients received study medication for at least 4 weeks (Treated Set includes all patients who were documented to have taken at least one dose of of treatment) | Posted | | Number | | participants | | after at least 4 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation | Worsening of RLS symptoms, in comparison to baseline, following abrupt treatment discontinuation (for patients with no added RLS therapy after study drug discontinuation). Assessment of worsening of RLS was based on the IRLS total score assessed 7 ± 1 days after treatment discontinuation (the end of the study or premature discontinuation) compared with that at baseline. Analysis considered the number of patients experiencing a clinically relevant deterioration of ≥4 points in total IRLS score 7 ± 1 days after discontinuation of trial medication compared with baseline. | Treated Set, all patients who were documented to have taken at least one dose of study medication | Posted | | Number | | participants | | after at least 1 week of treatment discontinuation | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
|
| Secondary | Baseline, Week 26 Mean Supine Systolic Blood Pressure | | Treated Set, all patients who were documented to have taken at least one dose of study medication | Posted | | Mean | Standard Deviation | mm Hg | | Baseline, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Baseline, Week 26 Mean Standing Systolic Blood Pressure | | Treated Set, all patients who were documented to have taken at least one dose of study medication | Posted | | Mean | Standard Deviation | mm Hg | | Baseline, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Baseline, Week 26 Mean Supine Diastolic Blood Pressure | | Treated Set, all patients who were documented to have taken at least one dose of study medication | Posted | | Mean | Standard Deviation | mm Hg | | Baseline, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Baseline, Week 26 Mean Standing Diastolic Blood Pressure | | Treated Set, all patients who were documented to have taken at least one dose of study medication | Posted | | Mean | Standard Deviation | mm Hg | | Baseline, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Baseline, Week 26 Mean Supine Pulse Rate | | Treated Set, all patients who were documented to have taken at least one dose of study medication | Posted | | Mean | Standard Deviation | bpm | | Baseline, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |
| Secondary | Baseline, Week 26 Mean Standing Pulse Rate | | Treated Set, all patients who were documented to have taken at least one dose of study medication | Posted | | Mean | Standard Deviation | bpm | | Baseline, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Pramipexole | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets | | OG001 | Placebo | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets |
| |