A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 116
- 试验地点
- 47
- 主要终点
- Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
详细描述
- 8 weeks open-label treatment period with milnacipran.
- Followed by randomization to 8-weeks double blind treatment period for eligible patients
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of primary fibromyalgia
- •13-17 years of age
- •To be eligible for screening, have average pain rating in the previous week of at least 3 but no more than 9 on an 11-point numeric rating scale
- •To be eligible to enter into the open-label treatment period, have a 1-week mean of daily pain ratings of at least 3 but no more than 9 (11-point numeric rating scale) in the week before Baseline (Visit 2)
- •To be eligible for randomization and entry into the double-blind treatment period, have a decrease of at least 50% in 1-week mean of daily pain ratings (11-point numeric rating scale) before Randomization (Visit 7) compared with the 1-week mean of daily pain ratings, in the week before Baseline (Visit 2)
- •Unsatisfactory response to nonpharmacologic fibromyalgia treatment.
排除标准
- •Severe psychiatric illness
- •Severe renal impairment
- •Evidence of active liver disease
- •Pregnant or breastfeeding
- •Significant risk of suicidality
- •Unable, unwilling or inadvisable to discontinue prohibited medications
- •History of alcohol abuse or drug abuse or dependence, within previous year
- •Current systemic infection
- •Autoimmune disease
- •History of seizure disorder (other than febrile seizures)
研究组 & 干预措施
Milnacipran
oral administration, twice daily dosing
干预措施: Milnacipran (Drug)
Placebo
oral administration, twice daily dosing
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.
时间窗: Change from Visit 7 (Week 8) to Visit 10 (Week 16)
During the open-label period, 20 patients out of 116 enrolled had a reduction from baseline (Visit 2) of at least 50% in their pain, were classified as responders and were randomized (Visit 7). A Loss of Therapeutic Response was said to occur if, during the double-blind treatment period, any of the following occurred: • A worsening of fibromyalgia requiring an alternate treatment OR • An increase in 1-week mean of daily pain ratings (11-point numeric rating scale) to greater than 70% of Baseline (Visit 2) OR • Withdrawal from the study for any reason except withdrawals due to extenuating circumstances
次要结局
- Patient Global Impression of Severity (PGIS)(Change from Visit 7 (Week 8) to Visit 10 (Week 16))