Clinical trial NCT00390689: A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.
Official title: A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Pramipexole at Fixed Doses of 0.25 mg, 0.5 mg, and 0.75 mg in Patients With Idiopathic Restless Legs Syndrome for 6 Weeks, Followed by a 46-week Open-label Long-term Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Restless Legs Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-10-20
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks
timeFrame: Week 6 - change from baseline
Secondary outcomes:
measure: IRLS Responder
timeFrame: baseline to week 6
measure: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks
timeFrame: Week 6 - change from baseline
measure: Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks
timeFrame: Week 6 - change from baseline
measure: Clinical Global Impression Global Improvement (CGI-I) Responder
timeFrame: baseline to week 6
measure: Patient Global Impression (PGI) Responder
timeFrame: baseline to week 6
measure: Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.
timeFrame: baseline to 6 weeks
measure: Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period
timeFrame: Week 52 - change from baseline
measure: IRLS Responder for Open-label Period
timeFrame: baseline to week 52
measure: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period
timeFrame: Week 52 - change from baseline
measure: Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period
timeFrame: Week 52 - change from baseline
measure: Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period
timeFrame: baseline to week 52
measure: Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period
timeFrame: baseline to week 52
measure: Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period
timeFrame: baseline to week 52
Other outcomes:
Locations:
city: Aichi-gun, Aichi
country: Japan
facility: 248.627.037 Boehringer Ingelheim Investigational Site
city: Fujisawa, Kanagawa
country: Japan
facility: 248.627.014 Boehringer Ingelheim Investigational Site
city: Fukuoka, Fukuoka
country: Japan
facility: 248.627.029 Boehringer Ingelheim Investigational Site
city: Hiroshima, Hiroshima
country: Japan
facility: 248.627.032 Boehringer Ingelheim Investigational Site
city: Kagoshima, Kagoshima
country: Japan
facility: 248.627.030 Boehringer Ingelheim Investigational Site
city: Kanagawa, Yokohama
country: Japan
facility: 248.627.013 Boehringer Ingelheim Investigational Site
city: Kanazawa, Ishikawa
country: Japan
facility: 248.627.033 Boehringer Ingelheim Investigational Site
city: Kawasaki, Kanagawa
country: Japan
facility: 248.627.027 Boehringer Ingelheim Investigational Site
city: Kitakyusyu, Fukuoka
country: Japan
facility: 248.627.023 Boehringer Ingelheim Investigational Site
city: Kitakyusyu, Fukuoka
country: Japan
facility: 248.627.024 Boehringer Ingelheim Investigational Site
city: Kochi, Kochi
country: Japan
facility: 248.627.022 Boehringer Ingelheim Investigational Site
city: Kodaira, Tokyo
country: Japan
facility: 248.627.034 Boehringer Ingelheim Investigational Site
city: Koriyama, Fukushima
country: Japan
facility: 248.627.038 Boehringer Ingelheim Investigational Site
city: Koriyama, Fukushima
country: Japan
facility: 248.627.041 Boehringer Ingelheim Investigational Site
city: Kumamoto, Kumamoto
country: Japan
facility: 248.627.039 Boehringer Ingelheim Investigational Site
city: Kurume, Fukuoka
country: Japan
facility: 248.627.003 Boehringer Ingelheim Investigational Site
city: Minato-ku, Tokyo
country: Japan
facility: 248.627.036 Boehringer Ingelheim Investigational Site
city: Mitaka-shi, Tokyo
country: Japan
facility: 248.627.025 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 248.627.015 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 248.627.017 Boehringer Ingelheim Investigational Site
city: Otaru, Hokkaido
country: Japan
facility: 248.627.011 Boehringer Ingelheim Investigational Site
city: Otsu, Shiga
country: Japan
facility: 248.627.026 Boehringer Ingelheim Investigational Site
city: Sakai,Osaka
country: Japan
facility: 248.627.002 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 248.627.010 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 248.627.035 Boehringer Ingelheim Investigational Site
city: Sendai, Miyagi
country: Japan
facility: 248.627.012 Boehringer Ingelheim Investigational Site
city: Shibuya-ku, Tokyo
country: Japan
facility: 248.627.001 Boehringer Ingelheim Investigational Site
city: Shimotsuga-gun,Tochigi
country: Japan
facility: 248.627.004 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 248.627.040 Boehringer Ingelheim Investigational Site
city: Takatsuki,Osaka
country: Japan
facility: 248.627.018 Boehringer Ingelheim Investigational Site
city: Tokorozawa, Saitama
country: Japan
facility: 248.627.028 Boehringer Ingelheim Investigational Site
city: Tokushima, Tokushima
country: Japan
facility: 248.627.019 Boehringer Ingelheim Investigational Site
city: Toyohashi, Aichi
country: Japan
facility: 248.627.016 Boehringer Ingelheim Investigational Site
city: Urasoe, Okinawa
country: Japan
facility: 248.627.031 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: