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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pramipexole 0.25 mg once daily | Experimental | Pramipexole 0.25 mg given once daily |
|
| Pramipexole 0.5 mg once daily | Experimental | Pramipexole 0.5 mg given once daily |
|
| Pramipexole 0.75 mg once daily | Experimental | Pramipexole 0.75 mg given once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole 0.125 mg tablet | Drug |
| ||
| Pramipexole 0.5 mg tablet |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 6 - change from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline to week 6 |
| Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks |
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Inclusion Criteria:
Male or female patients between 20 and 80 years
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):
Patients with a total score larger than 15 on the IRLS at Visit 2
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 248.627.037 Boehringer Ingelheim Investigational Site | Aichi-gun, Aichi | Japan | ||||
| 248.627.014 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
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). |
| Week 6 - change from baseline |
| 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) | Week 6 - change from baseline |
| 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. | baseline to week 6 |
| 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. | baseline to week 6 |
| 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 | 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). | Week 52 - change from baseline |
| 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) | baseline to week 52 |
| 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). | Week 52 - change from baseline |
| 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) | Week 52 - change from baseline |
| 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. | baseline to week 52 |
| 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. | baseline to week 52 |
| 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 | baseline to week 52 |
| Fujisawa, Kanagawa |
| Japan |
| 248.627.029 Boehringer Ingelheim Investigational Site | Fukuoka, Fukuoka | Japan |
| 248.627.032 Boehringer Ingelheim Investigational Site | Hiroshima, Hiroshima | Japan |
| 248.627.030 Boehringer Ingelheim Investigational Site | Kagoshima, Kagoshima | Japan |
| 248.627.013 Boehringer Ingelheim Investigational Site | Kanagawa, Yokohama | Japan |
| 248.627.033 Boehringer Ingelheim Investigational Site | Kanazawa, Ishikawa | Japan |
| 248.627.027 Boehringer Ingelheim Investigational Site | Kawasaki, Kanagawa | Japan |
| 248.627.023 Boehringer Ingelheim Investigational Site | Kitakyusyu, Fukuoka | Japan |
| 248.627.024 Boehringer Ingelheim Investigational Site | Kitakyusyu, Fukuoka | Japan |
| 248.627.022 Boehringer Ingelheim Investigational Site | Kochi, Kochi | Japan |
| 248.627.034 Boehringer Ingelheim Investigational Site | Kodaira, Tokyo | Japan |
| 248.627.038 Boehringer Ingelheim Investigational Site | Koriyama, Fukushima | Japan |
| 248.627.041 Boehringer Ingelheim Investigational Site | Koriyama, Fukushima | Japan |
| 248.627.039 Boehringer Ingelheim Investigational Site | Kumamoto, Kumamoto | Japan |
| 248.627.003 Boehringer Ingelheim Investigational Site | Kurume, Fukuoka | Japan |
| 248.627.036 Boehringer Ingelheim Investigational Site | Minato-ku, Tokyo | Japan |
| 248.627.025 Boehringer Ingelheim Investigational Site | Mitaka-shi, Tokyo | Japan |
| 248.627.015 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 248.627.017 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 248.627.011 Boehringer Ingelheim Investigational Site | Otaru, Hokkaido | Japan |
| 248.627.026 Boehringer Ingelheim Investigational Site | Otsu, Shiga | Japan |
| 248.627.002 Boehringer Ingelheim Investigational Site | Sakai,Osaka | Japan |
| 248.627.010 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 248.627.035 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 248.627.012 Boehringer Ingelheim Investigational Site | Sendai, Miyagi | Japan |
| 248.627.001 Boehringer Ingelheim Investigational Site | Shibuya-ku, Tokyo | Japan |
| 248.627.004 Boehringer Ingelheim Investigational Site | Shimotsuga-gun,Tochigi | Japan |
| 248.627.040 Boehringer Ingelheim Investigational Site | Shinjuku-ku, Tokyo | Japan |
| 248.627.018 Boehringer Ingelheim Investigational Site | Takatsuki,Osaka | Japan |
| 248.627.028 Boehringer Ingelheim Investigational Site | Tokorozawa, Saitama | Japan |
| 248.627.019 Boehringer Ingelheim Investigational Site | Tokushima, Tokushima | Japan |
| 248.627.016 Boehringer Ingelheim Investigational Site | Toyohashi, Aichi | Japan |
| 248.627.031 Boehringer Ingelheim Investigational Site | Urasoe, Okinawa | Japan |
| FG001 | 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 |
| FG002 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Set (FAS). | Posted | Least Squares Mean | Standard Error | Points on a scale | Week 6 - change from baseline |
|
|
| |||||||||||||||||||||||||||||||
| 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) | Full Analysis Set (FAS). | Posted | Number | Percentage of patients | baseline to week 6 |
| ||||||||||||||||||||||||||||||||||
| 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). | Full Analysis Set (FAS). | Posted | Least Squares Mean | Standard Error | Points on a scale | Week 6 - change from baseline |
| |||||||||||||||||||||||||||||||||
| 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) | Full Analysis Set (FAS). | Posted | Least Squares Mean | Standard Error | Points on a scale | Week 6 - change from baseline |
| |||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set (FAS). | Posted | Number | Percentage of patients | baseline to week 6 |
| ||||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set (FAS). | Posted | Number | Percentage of patients | baseline to week 6 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period. | Posted | Number | participants | baseline to 6 weeks |
| ||||||||||||||||||||||||||||||||||||
| 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). | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | Points on a scale | Week 52 - change from baseline |
| |||||||||||||||||||||||||||||||||
| 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) | Full Analysis Set (FAS). | Posted | Number | Percentage of patients | baseline to week 52 |
| ||||||||||||||||||||||||||||||||||
| 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). | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | Points on a scale | Week 52 - change from baseline |
| |||||||||||||||||||||||||||||||||
| 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) | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | Points on a scale | Week 52 - change from baseline |
| |||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set (FAS). | Posted | Number | Percentage of patients | baseline to week 52 |
| ||||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set (FAS). | Posted | Number | Percentage of patients | baseline to week 52 |
| ||||||||||||||||||||||||||||||||||
| 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 | Full Analysis Set (FAS). | Posted | Number | Percentage of patients | baseline to week 52 |
|
From the first dose of trial medication onwards through the observational phase (52 weeks).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pramipexole 0.25mg (Double-blind) | 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 | 0 | 48 | 32 | 48 | ||
| EG001 | Pramipexole 0.50mg (Double-blind) | 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 | 2 | 53 | 42 | 53 | ||
| EG002 | Pramipexole 0.75mg (Double-blind) | 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 | 0 | 53 | 42 | 53 | ||
| EG003 | Pramipexole 0.125mg (Open Label) | 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. The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime | 1 | 8 | 5 | 8 | ||
| EG004 | Pramipexole 0.25mg (Open Label) | 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. The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime | 5 | 140 | 58 | 140 | ||
| EG005 | Pramipexole 0.50mg (Open Label) | 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. The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime | 0 | 97 | 50 | 97 | ||
| EG006 | Pramipexole 0.75mg (Open Label) | 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. The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime | 0 | 41 | 29 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis bacterial | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.0 | Systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.0 | Systematic Assessment |
| |
| Maculopathy | Eye disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MEDDRA 11.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MEDDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Eustachian tube stenosis | Ear and labyrinth disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Abdomial pain upper | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Thirst | General disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 11.0 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| OG002 | 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 |
|
|
| OG001 | 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 |
| OG002 | 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 |
|
|
| OG001 | 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 |
| OG002 | 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 |
|
|
| 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 |
| OG002 | 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 |
|
|
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
| OG002 | 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 |
|
|
| OG002 | 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 |
|
|
| OG002 | Pramipexole 0.5mg Group | 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. The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
| OG003 | Pramipexole 0.75mg Group | 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. The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
|
|
| OG002 | Pramipexole 0.50mg Group | 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. The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
| OG003 | Pramipexole 0.75mg Group | 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. The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
|
|
| OG002 | Pramipexole 0.5mg Group | 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. The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
| OG003 | Pramipexole 0.75mg Group | 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. The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
|
|
| OG001 | Pramipexole 0.25mg Group | 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. The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
| OG002 | Pramipexole 0.5mg Group | 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. The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
| OG003 | Pramipexole 0.75mg Group | 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. The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
|
|
| OG002 | Pramipexole 0.5mg Group | 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. The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
| OG003 | Pramipexole 0.75mg Group | 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. The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
|
|
| OG002 | Pramipexole 0.5mg Group | 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. The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
| OG003 | Pramipexole 0.75mg Group | 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. The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
|
|
| OG002 | Pramipexole 0.5mg Group | 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. The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
| OG003 | Pramipexole 0.75mg Group | 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. The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime |
|
|