The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Development of migraine in migraine patients
研究概览
简要总结
The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.
Our three hypotheses are:
- Pre-treatment with Clemastin reduces PACAP38 sensitivity and inhibits development of migraine in migraine patients.
- Clemastin inhibits the increase in plasma concentration of TNF-alpha, histamine and tryptase after PACAP38-infusion.
- PACAP38 in lower dosages (4, 6 and 8 pmol/kg/min) induces migraine in migraine patients.
详细描述
The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •migraine patients fulfilling IHS criteria for migraine without aura, ages 18-50, 50-100 kg, fertile women must be using safe prevention
排除标准
- •other types of primary headache than migraine
- •headache on trial day or later than 48 hours before trial day
- •migraine up to three days before trial day
- •any type of cardiovascular disease
- •clinical signs or patient history of any type of illness that the medical doctor in charge of trials deems relevant for participation
研究组 & 干预措施
Placebo to PACAP38
Pre-treatment with placebo. PACAP38 8pmol/kg/min
干预措施: PACAP38 (Drug)
Clemastin 1 mg/ml to PACAP38 8pmol/kg/min
Pre-treatment with Clemastin 1 mg/ml PACAP38 8 pmol/kg/min
干预措施: PACAP38 (Drug)
结局指标
主要结局
Development of migraine in migraine patients
时间窗: Up to 12 months
次要结局
未报告次要终点
研究者
Song Guo
Medical Doctor, PhD.-student
Danish Headache Center