A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 400 mg/Day Lacosamide Tablets in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 159
- 主要终点
- Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)
研究概览
简要总结
This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.
详细描述
This was a proof-of-concept study and not powered for statistical comparisons.
The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day or placebo during the Maintenance Phase. Subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly intervals of 100mg. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase. No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, 18 to 65 years old
- •Fulfills all 3 points of American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia
- •At least moderate pain (pain intensity ≥ 5 on Likert pain scale (0-10) during the 7 days prior to Baseline)
- •Fibromyalgia Impact Questionnaire (FIQ) total score ≥ 50
- •Completed an adequate washout period for excluded medications prior to beginning the Baseline Diary Phase
排除标准
- •Symptomatic regional or structural rheumatic disease
- •Diagnosed neuropathic pain syndrome
- •Receiving treatment with neurostimulating devices
- •Significant psychopathology
- •History of chronic alcohol or drug abuse within 6 months prior to Screening
- •Been hospitalized for psychiatric or behavioral reasons within 6 months prior to Screening
- •Clinically significant abnormal vitals, cardiac dysfunction and /or arrhythmias
- •Taken neuroleptics, serotonin and norepinephrine reuptake inhibitors (SNRIs) or tricyclic antidepressants (TCAs)
- •Other medical conditions that could compromise the subject's ability to participate in the study
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Lacosamide
Lacosamide Tablet 400mg daily
干预措施: Lacosamide (Drug)
结局指标
主要结局
Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)
时间窗: Baseline, Last 2 weeks of the 12-week Treatment Phase
The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)
时间窗: Baseline, Last 2 weeks of the 12-week Treatment Phase
The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
次要结局
- Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase(Baseline, Last 2 weeks of the 12 week Treatment Phase)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase(Baseline, Last assessment in the 12-week Treatment Phase)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase(Baseline, Last assessment in the 12-week Treatment Phase)
- Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase(Baseline, Last 2 weeks of the 12-week Treatment Phase)
- Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase(Baseline, Last 2 weeks of the 12-week Treatment Phase)
- Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase(Baseline, Last assessment in the 12-week Treatment Phase)
- Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase(Baseline, Last assessment in the 12-week Treatment Phase)
- Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase(Baseline, Last 2 weeks of the 12 week Treatment Phase)
- Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12(End of the Maintenance Phase/Week 12)
- Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase(12-week Treatment Phase)
- Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase(12-week Treatment Phase)
- Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase(Baseline, Last assessment in the 12-week Treatment Phase)