A Single Blind, Placebo Controlled, Multi-Centre Study to Investigate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of the TRPV1 Antagonist SB-705498 Against the Pain of Acute Migraine.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- Percentage of subjects who are pain free at 2 hrs post-dose (e.g., have moderate to severe pain at baseline and no pain at 2 hrs post-dose).
研究概览
简要总结
Despite the success of the triptan class of drugs, approximately 60% of patients who take medication at the moderate to severe pain stage of acute migraine, still have pain of mild or greater degree at 2 hrs post dose. SB-705498 is a novel, first in class TRPV1 receptor antagonist under development for the treatment of migraine pain. Preclinical experiments have demonstrated that the TRPV1 receptor is expressed both centrally and peripherally in the trigeminal system and inhibition of TRPV1 with SB-705498 can both prevent and reverse established central sensitisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of subjects who are pain free at 2 hrs post-dose (e.g., have moderate to severe pain at baseline and no pain at 2 hrs post-dose).
次要结局
- Pain free at 30mins, 1,3,4,5&6hrs Headache relief and absence/presence of associated symptoms at 30 mins, 1,2,3,4,5&6hrs Additional migraine medication Safety tests ( e.g., continuous ECG, laboratory tests) Heat pain thresholds.
