A Phase 2 Randomized, Double-blind and Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Daily Average Pain Score (DAPS)
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy，safety and tolerability of SR750 in patients with trigeminal neuralgia (TN). Patients will receive SR750 (study drug) or placebo for 6 weeks and keep a diary of daily pain. The study duration for each patient is up to 11 weeks.
详细描述
This is a phase 2, randomized, double-blind study comparing SR750 with placebo in patients with trigeminal neuralgia. It consists of a screening period, a double-blind treatment period, and a post-treatment safety follow-up period. Baseline pain intensity and number of paroxysms will be taken in the run-in period of screening period and will be checked for eligibility. Around 162 eligible subjects will be recruited and randomized into three arms at 1:1:1 ratio to receive SR750 high dose twice a day (BID) , SR750 low dose BID or placebo BID for 6 weeks. Subjects, investigators, all clinical study site staffs, and the Sponsor will remain blinded to treatment assignment during the study. Subjects will be asked to record the number of paroxysms of pain, severity of daily average pain of paroxysms and severity of daily worst pain in e-diary over the last 24 hours every night before going to bed. After completion of double-blind period, subjects will continue to complete the safety follow-up.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of trigeminal neuralgia as per International Classification of Headache Disorders third version (ICHD-3) criteria
- •Subjects must have experienced ≥3 paroxysms per day with a daily average pain sore of ≥4 and ≤8 on PI-NRS during the five days prior to randomization.
- •Willing and able to undergo washout of prohibited medication as per protocol requirements and refrain from use of the prohibited medication throughout the study period.
- •Female subjects must be non-pregnant and non-lactating.
排除标准
- •Secondary trigeminal neuralgia
- •Painful trigeminal neuropathies
- •Other pains that cannot be clearly differentiated from the pain associated with TN or may interfere with the pain assessment
- •Subjects have previously undergone microvascular decompression (MVD), sensory rhizotomy of trigeminal nerve, radiofrequency ablation (RFA), percutaneous balloon compression (PBC), permanent lesion of trigeminal semilunar ganglion, botulinum toxin type A for the treatment of TN within 6 months prior to screening. Subjects with severe complication after therapeutic procedure would also be excluded.
- •Known history of human immunodeficiency virus (HIV) or active infection of hepatitis B virus (HBV), hepatitis C virus (HCV) or Treponema Pallidum
研究组 & 干预措施
SR750 high dose
干预措施: SR750 tablet (Drug)
SR750 low dose
干预措施: SR750 tablet (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Daily Average Pain Score (DAPS)
时间窗: up to week 6
Change from baseline to week 6 in the weekly average of the daily average pain score (DAPS) of paroxysms using pain intensity numerical rating scale (PI-NRS).The PI-NRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
次要结局
- Proportion of responders(up to week 6)
- Mean pain score by week(up to week 6)
- Mean worst pain score by week(up to week 6)
- Mean number of paroxysms by week(up to week 6)
- Mean continuous pain score by week(up to week 6)
- Proportion of subjects with continuous pain at week 6(up to week 6)
- Hospital Anxiety and Depression Scale (HADS)(up to week 6)
- Use of rescue medication(up to week 7)