NCT00685815已完成2 期
Intravenous Iron Metabolism in Restless Legs Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Duration Off Treatment
研究概览
简要总结
Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome
详细描述
To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS) symptoms and brain concentrations of iron.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Restless Legs Syndrome (RLS).
- •Presence of increased periodic leg movements of sleep (PLMS) before receiving treatment.
- •Patient sleep times are between 9pm and 9am.
- •Patient's RLS symptoms would occur daily if you were not on medication.
排除标准
- •RLS secondary to other medical disorders as determined by history and physical/neurological examination.
- •On a treatment (e.g., psychiatric medication) that might significantly alter RLS symptoms or study results and who cannot discontinue medication for the extended period of the study.
- •History of multiple adverse drug reactions or specifically an allergy to IV iron.
- •Currently experiencing a serious medical condition (chronic organ failure, active inflammation or infection, congestive heart failure, etc.) that might alter iron metabolism, would place them at risk, or interfere with study participation.
- •An magnetic resonance imaging (MRI) is not possible because of medical reasons (Pacemaker; loose iron in the tissue) or concern about severe claustrophobia.
- •Any condition that is likely to increase iron loss (chronic bleeding, excluding menstruation; medically necessary phlebotomy) or consumption (pregnancy).
- •Serum ferritin >300mg/L or percent iron saturation >50%. This is to exclude subjects with probable hemochromatosis.
- •Significant medical (e.g., inflammatory bowel syndrome; bowel dysmotility syndromes) or surgical (e.g., gastrojejunal bypass, colectomy) GI tract problems; and active chronic inflammatory processes (e.g., active hepatitis, rheumatoid arthritis, systemic lupus erythematosus). This is to exclude conditions which will potentially alter iron metabolism.
研究组 & 干预措施
Ferric carboxymaltose (FCM)
Experimental
Intravenous iron (FCM)
干预措施: Ferric Carboxymaltose (FCM) (Drug)
Placebo
Placebo Comparator
normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Duration Off Treatment
时间窗: 2 weeks, 4 weeks, and 52 weeks
Number of weeks that patients were able to remain off treatment for RLS
次要结局
未报告次要终点
研究者
研究点 (1)
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