Idiopathic Restless Legs Syndrome
Conditions
Brief summary
The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this trial is to investigate the long term safety and efficacy of pramipexole in RLS.
Interventions
DRUGPramipexole 0.125 mg tablet
DRUGPramipexole 0.5 mg tablet
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients between 20 and 80 years 2. Patients with a diagnosis of restless legs syndrome (RLS) according to the following diagnosis criteria of National institute of health (NIH)/International restless legs syndrome study group (IRLSSG): 1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. 2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting. 3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues. 4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. 3. Patients with a total score larger than 15 on the IRLS at Visit 2
Exclusion criteria
1. Premenopausal women who meet any of the following 1) to 3) 1) Patients who are pregnant or possibly pregnant 2) Patients who are lactating 3) Patients who wish to become pregnant during the study period 2. Patients who cannot take adequate contraceptive measures 3. Patients with a history of akathisia induced by neuroleptics 4. Patients with diabetes mellitus requiring insulin therapy 5. Patients who are judged to have microcytic anaemia by the investigator or sub-investigator 6. Patients with a history or signs of peripheral neuropathy, myelopathy, multiple sclerosis, Parkinson's disease or other neurological diseases that may result in the occurrence of secondary RLS in the physical function tests or neurological tests 7. Patients with other sleep disorders such as abnormal behaviour during Rapid eye movement (REM) sleep, narcolepsy and sleep apnoea syndrome (patients with an apnoea-hypopnoea index (AHI) exceeding 15 determined by polysomnography at the relevant trial site or those with loud snoring at least 5 nights/week and an experience of respiratory arrest during sleep or excessive daytime sleepiness)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks | Week 6 - change from baseline | The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). A decrease in the score of the IRLS by 10 or more points corresponds to the improvement of severity by one rank and has clinical importance. Therefore, the primary endpoint in the double-blind period was set as a decrease by 10 or more points in the mean change on the total score of the IRLS from the baseline to Visit 5 (last observation day in the double-blind period) at all doses of 0.25 mg, 0.5 mg, and 0.75 mg/day of pramipexole. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks | Week 6 - change from baseline | PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep). |
| Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks | Week 6 - change from baseline | ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep) |
| Clinical Global Impression Global Improvement (CGI-I) Responder | baseline to week 6 | CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders. |
| Patient Global Impression (PGI) Responder | baseline to week 6 | PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders. |
| Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period. | baseline to 6 weeks | — |
| Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period | Week 52 - change from baseline | The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). |
| IRLS Responder | baseline to week 6 | The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications) |
| Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period | Week 52 - change from baseline | PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep). |
| Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period | Week 52 - change from baseline | ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep) |
| Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period | baseline to week 52 | CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders. |
| Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period | baseline to week 52 | PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders. |
| Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period | baseline to week 52 | Possible augmentation defined as persistence of a state in which RLS symptoms begin to occur 2 hours earlier than the usual time zone for 5 days or more a week |
| IRLS Responder for Open-label Period | baseline to week 52 | The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications) |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pramipexole 0.25mg Group Double-blind period: 0.25 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime | 48 |
| Pramipexole 0.5mg Group Double-blind period: 0.5 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime | 53 |
| Pramipexole 0.75mg Group Double-blind period: 0.75 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime | 53 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 5 | 2 |
| Overall Study | Investigator's judgement | 2 | 0 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Pramipexole 0.25mg Group | Pramipexole 0.5mg Group | Pramipexole 0.75mg Group | Total |
|---|---|---|---|---|
| Age, Continuous | 52.5 years STANDARD_DEVIATION 13.9 | 52.4 years STANDARD_DEVIATION 12.9 | 54.3 years STANDARD_DEVIATION 14.4 | 53.1 years STANDARD_DEVIATION 13.7 |
| Sex: Female, Male Female | 30 Participants | 27 Participants | 32 Participants | 89 Participants |
| Sex: Female, Male Male | 18 Participants | 26 Participants | 21 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 32 / 48 | 42 / 53 | 42 / 53 | 5 / 8 | 58 / 140 | 50 / 97 | 29 / 41 |
| serious Total, serious adverse events | 0 / 48 | 2 / 53 | 0 / 53 | 1 / 8 | 5 / 140 | 0 / 97 | 0 / 41 |
Outcome results
Primary
Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks
The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). A decrease in the score of the IRLS by 10 or more points corresponds to the improvement of severity by one rank and has clinical importance. Therefore, the primary endpoint in the double-blind period was set as a decrease by 10 or more points in the mean change on the total score of the IRLS from the baseline to Visit 5 (last observation day in the double-blind period) at all doses of 0.25 mg, 0.5 mg, and 0.75 mg/day of pramipexole.
Time frame: Week 6 - change from baseline
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole 0.25mg Group | Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks | -12.3 Points on a scale | Standard Error 1.1 |
| Pramipexole 0.5mg Group | Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks | -12.5 Points on a scale | Standard Error 1.1 |
| Pramipexole 0.75mg Group | Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks | -11.8 Points on a scale | Standard Error 1.1 |
Secondary
Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period
The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe).
Time frame: Week 52 - change from baseline
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole 0.25mg Group | Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period | -18.5 Points on a scale | Standard Deviation 5.8 |
| Pramipexole 0.5mg Group | Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period | -17.3 Points on a scale | Standard Deviation 5.8 |
| Pramipexole 0.75mg Group | Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period | -18.3 Points on a scale | Standard Deviation 6.1 |
| Pramipexole 0.75mg Group | Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period | -14.8 Points on a scale | Standard Deviation 8.9 |
Secondary
Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period
ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)
Time frame: Week 52 - change from baseline
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole 0.25mg Group | Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period | -9.5 Points on a scale | Standard Deviation 2.9 |
| Pramipexole 0.5mg Group | Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period | -3.8 Points on a scale | Standard Deviation 4.3 |
| Pramipexole 0.75mg Group | Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period | -4.4 Points on a scale | Standard Deviation 4.7 |
| Pramipexole 0.75mg Group | Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period | -2.6 Points on a scale | Standard Deviation 5.7 |
Secondary
Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks
ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)
Time frame: Week 6 - change from baseline
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole 0.25mg Group | Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks | -2.6 Points on a scale | Standard Error 0.6 |
| Pramipexole 0.5mg Group | Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks | -3.0 Points on a scale | Standard Error 0.5 |
| Pramipexole 0.75mg Group | Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks | -2.3 Points on a scale | Standard Error 0.6 |
Secondary
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period
PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).
Time frame: Week 52 - change from baseline
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole 0.25mg Group | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period | -4.0 Points on a scale | Standard Deviation 2.4 |
| Pramipexole 0.5mg Group | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period | -3.3 Points on a scale | Standard Deviation 3.3 |
| Pramipexole 0.75mg Group | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period | -3.3 Points on a scale | Standard Deviation 3.3 |
| Pramipexole 0.75mg Group | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period | -2.4 Points on a scale | Standard Deviation 3.8 |
Secondary
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks
PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).
Time frame: Week 6 - change from baseline
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole 0.25mg Group | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks | -3.2 Points on a scale | Standard Error 0.4 |
| Pramipexole 0.5mg Group | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks | -3.2 Points on a scale | Standard Error 0.4 |
| Pramipexole 0.75mg Group | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks | -2.5 Points on a scale | Standard Error 0.4 |
Secondary
Clinical Global Impression Global Improvement (CGI-I) Responder
CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.
Time frame: baseline to week 6
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pramipexole 0.25mg Group | Clinical Global Impression Global Improvement (CGI-I) Responder | 77.1 Percentage of patients |
| Pramipexole 0.5mg Group | Clinical Global Impression Global Improvement (CGI-I) Responder | 75.5 Percentage of patients |
| Pramipexole 0.75mg Group | Clinical Global Impression Global Improvement (CGI-I) Responder | 69.8 Percentage of patients |
Secondary
Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period
CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.
Time frame: baseline to week 52
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pramipexole 0.25mg Group | Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period | 100.0 Percentage of patients |
| Pramipexole 0.5mg Group | Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period | 95.0 Percentage of patients |
| Pramipexole 0.75mg Group | Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period | 98.0 Percentage of patients |
| Pramipexole 0.75mg Group | Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period | 84.0 Percentage of patients |
Secondary
Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.
Time frame: baseline to 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole 0.25mg Group | Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period. | Blood pressure increased | 0 participants |
| Pramipexole 0.25mg Group | Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period. | Cardiovascular disorder | 0 participants |
| Pramipexole 0.5mg Group | Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period. | Blood pressure increased | 1 participants |
| Pramipexole 0.5mg Group | Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period. | Cardiovascular disorder | 0 participants |
| Pramipexole 0.75mg Group | Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period. | Blood pressure increased | 0 participants |
| Pramipexole 0.75mg Group | Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period. | Cardiovascular disorder | 1 participants |
Secondary
IRLS Responder
The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)
Time frame: baseline to week 6
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pramipexole 0.25mg Group | IRLS Responder | 60.4 Percentage of patients |
| Pramipexole 0.5mg Group | IRLS Responder | 58.5 Percentage of patients |
| Pramipexole 0.75mg Group | IRLS Responder | 49.1 Percentage of patients |
Secondary
IRLS Responder for Open-label Period
The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)
Time frame: baseline to week 52
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pramipexole 0.25mg Group | IRLS Responder for Open-label Period | 100.0 Percentage of patients |
| Pramipexole 0.5mg Group | IRLS Responder for Open-label Period | 90.0 Percentage of patients |
| Pramipexole 0.75mg Group | IRLS Responder for Open-label Period | 92.0 Percentage of patients |
| Pramipexole 0.75mg Group | IRLS Responder for Open-label Period | 68.0 Percentage of patients |
Secondary
Patient Global Impression (PGI) Responder
PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.
Time frame: baseline to week 6
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pramipexole 0.25mg Group | Patient Global Impression (PGI) Responder | 72.9 Percentage of patients |
| Pramipexole 0.5mg Group | Patient Global Impression (PGI) Responder | 79.2 Percentage of patients |
| Pramipexole 0.75mg Group | Patient Global Impression (PGI) Responder | 67.9 Percentage of patients |
Secondary
Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period
PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.
Time frame: baseline to week 52
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pramipexole 0.25mg Group | Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period | 100.0 Percentage of patients |
| Pramipexole 0.5mg Group | Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period | 97.5 Percentage of patients |
| Pramipexole 0.75mg Group | Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period | 94.0 Percentage of patients |
| Pramipexole 0.75mg Group | Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period | 80.0 Percentage of patients |
Secondary
Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period
Possible augmentation defined as persistence of a state in which RLS symptoms begin to occur 2 hours earlier than the usual time zone for 5 days or more a week
Time frame: baseline to week 52
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pramipexole 0.25mg Group | Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period | 0.0 Percentage of patients |
| Pramipexole 0.5mg Group | Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period | 0.0 Percentage of patients |
| Pramipexole 0.75mg Group | Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period | 0.0 Percentage of patients |
| Pramipexole 0.75mg Group | Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period | 0.0 Percentage of patients |