NCT01981941已完成4 期
Post-marketing Clinical Study of Gabapentin Enacarbil -Non-blinded Study in Restless Legs Syndrome (RLS) Patients With Moderate Renal Impairment-
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Change in International Restless Leg Syndrome (IRLS) rating scale score
研究概览
简要总结
To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to severe primary RLS patients with moderate renal impairment and to confirm dosage and administration in such population.
详细描述
This study is a multicenter, non-blinded, non-comparative study. Patients who meet the eligible criteria will undergo one week observation period followed by four week treatment period. In treatment period, patients will receive gabapentin enacarbil orally one daily after dinner. After the four-week treatment period with gabapentin enacarbil, a one-week post-observation period will be undertaken.
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 have been diagnosed with restless legs syndrome (RLS) according to the international RLS Study Group Diagnostic Criteria
- •Patients whose score is 15 or greater on the International RLS (IRLS) Rating Scale on the first day of the pre-observation period.
- •Patients whose creatinine clearance level at the first day of pre-observation period is ≥30 mL/min to <60mL/min estimated by Cockcroft-Gaul t equation
- •Patients who provide written consent
排除标准
- •Patients with sleep disorder such as sleep apnea syndrome, which affects the RLS evaluation
- •Patients with history of augmentation and treatment rebound of RLS symptoms when using dopamine agonis
- •Patients with neuropathy and movement disorder (diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesia, rheumatoid arthritis etc)
- •Patients with uncontrolled diabetes [HbA1c>7.5% (NGSP value), in the past six months], iron deficiency anemia, or drug administration of hypnotic sedatives.
- •Patients who attempted suicide within six months prior to the consent obtained, or who have been diagnosed as a suicide risk by investigator or sub-investigator
- •Patients with moderate or severe depression
- •Patients with alcohol dependence or drug intoxication or who have a history of abuse or drug dependence in the past one year
- •Patients whose job is shift work, professional driver, or engaging in hazardous activities such as operating machinery
- •Patients with history of hypersensitivity to gabapentin
- •Patients who have experience to participate in other post-marketing clinical studies or clinical trials within 12 weeks prior to the start of pre-observation
- •Others: patients who are concluded to be ineligible by an investigator or sub-investigator as ineligible
研究组 & 干预措施
Treatment group
Experimental
Oral
干预措施: Gabapentin enacarbil (Drug)
结局指标
主要结局
Change in International Restless Leg Syndrome (IRLS) rating scale score
时间窗: Baseline and at 4 week of the treatment (or at discontinuation)
次要结局
- Plasma gabapentin concentration(Up to 5 weeks)
- Change in Patient-related clinical global impression (PCGI) score(Baseline and at 4 week of the treatment (or at discontinuation))
- Change in Investigator-rated clinical global impression (ICGI) score(Baseline and at 4 week of the treatment (or at discontinuation))
- Safety assessed by the incidence of adverse events, vital signs, labo-tests, body weight and Epworth sleepiness scale(Up to 5 weeks)
研究者
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