A Phase 2b, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken at Bedtime in Patients With Fibromyalgia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 17
- 主要终点
- Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12
研究概览
简要总结
TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat 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
- •Diagnosis of primary Fibromyalgia (ACR criteria)
- •Male or female 18-65 years old
- •For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent therapy
- •Willing and able to withdraw specific therapies (ask PI)
- •Medically acceptable form of contraception (female only)
- •Signed informed consent
排除标准
- •Arthritis, lupus and other systemic auto-immune diseases
- •Regional or persistent pain that could interfere with assessment of fibromyalgia pain
- •Bipolar and psychotic disorders
- •Increased risk of suicide
- •Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
- •Inability to wash-off specific medications (ask PI)
- •Known hypersensitivity to cyclobenzaprine
- •Others: seizure disorders, sleep apnea, continuous positive airway pressure (CPAP) use, BMI>40
研究组 & 干预措施
TNX-102 SL 2.8 mg
Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks.
干预措施: TNX-102 SL 2.8mg (Drug)
Placebo
Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12
时间窗: Baseline, Week 12
Daily pain scores were assessed using a 24-hour recall response provided by each patient via an interactive voice response system (IVRS) daily telephone diary. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Jump to control was used to replace missing data in each treatment arm.
次要结局
- 30% Responder Analysis of IVRS NRS Pain Assessments at Week 12(Baseline, Week 12)
- Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance(Baseline, Week 12)
- Patient Global Impression of Change (PGIC) Responder Status ("Very Much Improved" or "Much Improved" vs All Other Categories) at Week 12(Week 12)
- Change From Baseline to Week 12 in FIQ-R Total Score(Baseline, Week 12)