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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 34
- 主要终点
- Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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):
- •An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
- •The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
- •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.
- •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.
- •Patients with a total score larger than 15 on the IRLS at Visit 2
排除标准
- •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
- •Patients who cannot take adequate contraceptive measures
- •Patients with a history of akathisia induced by neuroleptics
- •Patients with diabetes mellitus requiring insulin therapy
- •Patients who are judged to have microcytic anaemia by the investigator or sub-investigator
- •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
- •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)
研究组 & 干预措施
Pramipexole 0.25 mg once daily
Pramipexole 0.25 mg given once daily
干预措施: Pramipexole 0.125 mg tablet (Drug)
Pramipexole 0.5 mg once daily
Pramipexole 0.5 mg given once daily
干预措施: Pramipexole 0.5 mg tablet (Drug)
Pramipexole 0.75 mg once daily
Pramipexole 0.75 mg given once daily
干预措施: Pramipexole 0.125 mg tablet (Drug)
Pramipexole 0.75 mg once daily
Pramipexole 0.75 mg given once daily
干预措施: Pramipexole 0.5 mg tablet (Drug)
结局指标
主要结局
Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks
时间窗: 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.
次要结局
- IRLS Responder(baseline to week 6)
- Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks(Week 6 - change from baseline)
- 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 Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks(Week 6 - change from baseline)
- Clinical Global Impression Global Improvement (CGI-I) Responder(baseline to week 6)
- Patient Global Impression (PGI) Responder(baseline to week 6)
- Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period(Week 52 - change from baseline)
- IRLS Responder for Open-label Period(baseline to week 52)
- Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period(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(Week 52 - change from baseline)
- Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period(baseline to week 52)
- Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period(baseline to week 52)
- Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period(baseline to week 52)