A Multicenter Open-Label Extension Study to Evaluate the Efficacy and Safety of HORIZANT (Gabapentin Enacarbil) Extended-Release Tablets in Adolescents Aged 13 to 17 Years Old With Moderate-to-Severe Primary Restless Legs Syndrome
试验速览
- 阶段
- 4 期
- 入组人数
- 144
- 试验地点
- 11
- 主要终点
- Clinical Global Impression of Improvement (CGI-I) score
研究概览
简要总结
The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS.
详细描述
Patients who complete the 12-week daily dosing efficacy and safety study (XP109) will be allowed to enroll in the open-label extension (OLE) study (XP110), thereby providing exposure to HORIZANT for up to 48 weeks. Enrolled patients will take open-label HORIZANT 600 mg tablets once a day at approximately 5 PM with food, beginning at Week 0 of the OLE study up to and including Week 36. After the end of the treatment period, a follow-up visit will be included 14 days (± 3 days) after the last dose of HORIZANT. Patients will visit the clinical site on 6 different occasions, including a follow-up visit 14 days (± 3 days) after the last dose of study drug.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who completed participation in HORIZANT Study XP
- •Negative pregnancy test for females of childbearing potential. Male patients able to father a child must agree to use a barrier method (male condom, female condom, diaphragm, or cervical cap) with spermicide for at least 30 days prior to dosing and throughout the study. Fertile, sexually active patients must agree to use 2 medically accepted methods of contraception
- •Patients must be willing to refrain from using any drugs that are likely to affect RLS or sleep assessments for the duration of the study.
- •Signed patient and parent (or legal guardian) Institutional Review Board (IRB)-approved assent and consent forms before any study procedures are carried out
排除标准
- •Patients who, in the opinion of the investigator, would be noncompliant with the study visit schedule, procedures, or medication administration
- •Patients who have developed clinically significant or unstable medical conditions, or who would otherwise be unsuitable for participation in a continuation study with gabapentin enacarbil
研究组 & 干预措施
HORIZANT 600 mg
HORIZANT 600 mg once daily
干预措施: HORIZANT 600 mg (Drug)
结局指标
主要结局
Clinical Global Impression of Improvement (CGI-I) score
时间窗: Week 12
assessment at designated timepoints
次要结局
未报告次要终点