NCT02658188已完成3 期
Long-term Study - Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 182
- 主要终点
- Safety assessed by Adverse Events
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin enacarbil) for long-term treatment of restless legs syndrome patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who diagnosed with RLS according to the diagnostic criteria established by the International RLS Study Group
- •International Restless Legs Syndrome Scale (IRLS) score ≥15 presence of RLS symptoms on ≥15 days per month and ≥4 days per week preceding inclusion in this study
排除标准
- •Patients using dopamine agonists or gabapentin within 1 week before or any anti-RLS treatment within 2 weeks before the start of the pretreatment observation period
- •Patients with an estimated creatinine clearance <60 mL/min determined using the Cockcroft-Gault formula
- •Pregnant or lactating women
- •Individuals with serum ferritin <20 ng/mL were also excluded from the trial
- •Individuals with movement disorders and/or abnormal neurological findings
研究组 & 干预措施
ASP8825 group
Experimental
干预措施: ASP8825 (Drug)
结局指标
主要结局
Safety assessed by Adverse Events
时间窗: Up to Week 52
Safety assessed by Laboratory tests
时间窗: Up to Week 52
Hematology, blood biochemistry, thyroid function test and urinalysis
Change from baseline in IRLS score
时间窗: Baseline to Week 52
IRLS: International Restless Legs Syndrome Scale
Safety assessed by 12-lead-electrocardiogram
时间窗: Up to Week 52
Safety assessed by Vital signs
时间窗: Up to Week 52
Blood pressure and pulse rate
次要结局
- Change from baseline in SF-36v2(Baseline to Week 52)
- Change from baseline in MOS sleep scale(Baseline to Week 52)
- Proportion of responders on ICGl of improvement(Up to Week 52)
- Proportion of responders on PCGI of improvement(Up to Week 52)
- Change from baseline in PSQI(Baseline to Week 52)
- Change from baseline in RLS-QOL(Baseline to Week 52)
- Plasma concentration of gabapentin(Week 12, 28 and 52)
研究者
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