To Examine the Effect of Horizant (Gabapentin Enacarbil) in Primary Restless Legs Syndrome (RLS) Patients Who Are on Dopaminergic Agents and Exhibiting Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Augmentation Severity From Day 0 to Day 90
研究概览
简要总结
Restless Legs Syndrome (RLS) is a common neurological disorder. Augmentation is the main complication during long-term DA treatment of RLS. This study aims to examine effect of Horizant (Gabapentin Enacarbil) on Augmentation in RLS patients.
详细描述
This is an Open label single arm study. The purpose of the study is to demonstrate the efficacy of Horizant in patients with RLS who exhibit augmentation while on Dopaminergic therapy. Adult patients (age 18-85 years) with diagnosis of primary RLS (diagnosed by study investigators) with augmentation on dopaminergic therapy will be screened for participation in the study. RLS diagnosis will be made by the study investigators using International RLS study group criteria. Patients with augmentation on dopaminergic therapy as defined by NIH 2007 with ASRS of 5 to 15 will be offered to participate in the study. Inclusion and exclusion criteria are listed below. The study will be performed after approval of the Institutional Review Board of the University of Missouri.
A total of 50 subjects will be entered into the study over a period of 1 year. Written consent will be obtained from all patients. After pre-participation evaluation for eligibility, subjects will be selected and enrolled in the study and followed for a total of 6 follow up visits (Days 0, 30, 90, 120, 180, 360). Subjects Enrollment period will last up to 12 months. The total duration of study will be 24 months.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with diagnosis of RLS for more than one year.
- •Patients who are on DA therapy for 6 months or longer.
- •Patients who developed Augmentation (on stable dose of DA) lasting for 3 months or longer.
- •Augmentation severity rating scale of 5 to
- •Both males and females
- •Age range = 18-85 year
排除标准
- •Known Hypersensitivity to Horizant or Gabapentin products
- •Peripheral neuropathy
- •Radiculopathy
- •Peripheral vascular disease
- •Uremia [abnormal blood urea nitrogen (BUN) or Creatinine on Comprehensive Metabolic Panel (CMP)]
- •Patients who are currently pregnant
- •Patients who currently take opioids, lithium, anti-nausea medications (e.g. metoclopramide), dopaminergic antagonists (e.g. Haloperidol), 1st generation antihistamines (e.g. diphenhydramine, pseudoephedrine), anti-psychotic medications and iron therapy.
- •Subjects with impaired decision making capability.
研究组 & 干预措施
open-label
open-label single arm study
Horizant, 600 mg oral once daily at 5 pm for 360 days.
干预措施: Horizant (Drug)
结局指标
主要结局
Change in Augmentation Severity From Day 0 to Day 90
时间窗: From Day 0 (Baseline) to Day 90
Augmentation severity rating scale; 0-24, 0 is better, 24 is worst
次要结局
- Change in Augmentation Severity Rating Scale Form Day 0 to Day 360 (270 Days After Discontinuation pf Dopaminergic Medication)(Day 0 to day 360 (270 days after discontinuing dopaminergic medication))
研究者
Pradeep Sahota
Professor & Chairman, Dept. of Neurology
University of Missouri-Columbia