A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 457
- 试验地点
- 1
- 主要终点
- Change From Baseline to the Week 14 Endpoint in the Diary NRS Weekly Average of Daily Self Reported Average Pain Severity Scores.
研究概览
简要总结
This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is male or female 18 to 65 years of age, inclusive.
- •The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
排除标准
- •The patient has been diagnosed with infectious or inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attacks within past 2 years is exclusionary), or meets criteria for other type of systemic autoimmune disease.
研究组 & 干预措施
TNX-102 SL Tablet, 5.6 mg
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
干预措施: TNX-102 SL Tablet, 5.6 mg (Drug)
Placebo SL Tablet
1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
干预措施: Placebo SL Tablet (Drug)
结局指标
主要结局
Change From Baseline to the Week 14 Endpoint in the Diary NRS Weekly Average of Daily Self Reported Average Pain Severity Scores.
时间窗: Baseline (Day -7 to Day -1), Week 14
Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome.
次要结局
- Proportion of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved" at the Week 14 Endpoint(Week 14)
- Change From Baseline in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score at the Week 14 Endpoint(Day 1, Week 14)
- Change From Baseline in the FIQ-R Function Domain Score at the Week 14 Endpoint(Day 1, Week 14)
- Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance at the Week 14 Endpoint(Day 1, Week 14)
- Change From Baseline in the PROMIS Score for Fatigue at the Week 14 Endpoint(Day 1, Week 14)
- Change From Baseline in the Weekly Average of the Daily Diary Assessment of Sleep Quality at the Week 14 Endpoint(Baseline (Day -7 to Day -1), Week 14)