NCT00584246撤回4 期
Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- International RLS Study Group Severity Scale (IRLS)
研究概览
简要总结
This study will evaluate the safety and efficacy of Pregabalin (Lyrica) in treating patients with Restless Legs Syndrome (RLS) in a double-blind, placebo-controlled trial.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with RLS diagnosed by a movement disorder specialist/ Sleep specialist .
- •Patients must report some degree of pain which occurs on a regular basis.
- •Age 18 years to 80 years.
- •Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
- •Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
- •Willing and able to provide informed consent.
- •Willing to comply with protocol. -
排除标准
- •Any illness that in the investigator's opinion preclude participation in this study.
- •Pregnancy or lactation.
- •Concurrent participation in another clinical study.
- •Current treatment with a dopamine agonist (unless stopped at least 2 weeks prior to baseline).
- •Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
- •Legal incapacity or limited legal capacity.
- •Presence of severe renal disease BUN 50% greater than normal, Patients must have evidence from their PCP or Urologists of normal PSA and urodynamic tests within the last 12 month. Normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L. Labs will be requested from PCP.
- •Presence of major hepatic impairment (Cirrhosis, Viral Hepatitis, Nonalcoholic Steatohepatitis, Wilson's disease, or Hemochromatosis). LFT must show non-clinically significant results (Albumin range 3.0-6.0; Alkaline phosphatase range 40-150; ALT range 0-55; AST range 5-34).
- •Presence of severe daytime sleepiness.
- •Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
- •Patients taking dopamine agonists for any condition other than RLS. -
研究组 & 干预措施
1
Experimental
Pregabalin (Lyrica)
干预措施: Pregabalin (Lyrica) (Drug)
2
Placebo Comparator
Placebo
干预措施: Pregabalin (Lyrica) (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
International RLS Study Group Severity Scale (IRLS)
时间窗: 2 months
次要结局
- Clinical Global Impression (CGI)(2 months)
研究者
Theresa Zesiewicz, MD
Professor of Neurology
University of South Florida
研究点 (1)
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