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.
IRLS ResponderChange From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks
Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks
Clinical Global Impression Global Improvement (CGI-I) Responder
Patient Global Impression (PGI) Responder
Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.
Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period
IRLS Responder for Open-label Period
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period
Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period
Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period
Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period
Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
248.627.037 Boehringer Ingelheim Investigational Site, Aichi-gun, Aichi, Japan
248.627.014 Boehringer Ingelheim Investigational Site, 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