临床试验/NCT00197080

NCT00197080已完成3 期

A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients With Restless Legs Syndrome

GlaxoSmithKline70 个研究点分布在 1 个国家目标入组 380 人开始时间: 2005年6月1日最近更新: 2016年9月23日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 380
试验地点: 70
主要终点: The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (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: Double

入排标准

年龄范围: 18 Years 至 79 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosed with RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS Rating Scale.
•Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.

排除标准

•Have secondary RLS.
•Have any medical conditions that may impact efficacy assessments or that may present a safety concern.

结局指标

主要结局

The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12.

时间窗: 12 Weeks

次要结局

Assess safety, tolerability, and patient-reported outcomes, including changes in the Clinical Global Impression Scale Scores and changes in the Medical Outcomes Study Sleep Scale at Week 12.(12 Weeks)

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (70)

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