Amylin and CGRP Migraine Provocation in Migraine Without Aura Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Migraine incidence
研究概览
简要总结
Amylin and calcitonin gene related peptide (CGRP) are related to the same peptide family. Both share 16 out of 37 amino acids and can activate each others receptor. CGRP is implicated in migraine pathophysiology but the role of Amylin and its receptor in migraine is not fully clarified.
详细描述
Amylin is a peptide hormone that binds to a G-protein coupled receptor (GPCR). amylin was originally found in the pancreas (Beta Cell of Islets of Langerhans) but also shown to be present in the trigeminal ganglion, hind horn ganglia and perivascular nerve fibers.
Amylin has many similarities with CGRP. Amylin and CGRP share 16 out 37 amino acids. Both peptides can activate the amylin 1 subtype (AMY1)receptor with high affinity and reported to have more similar physiological and pharmacological effects.
In addition, both peptides increase the intracellular concentration of cyclic AMP (cAMP) which has a central role in migraine pathophysiology.
The aim of the study is pin point the role of amylin and amylin receptor compare to CGRP in migraine pathophysiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Migraine patients meeting International Headache Society (IHS) criteria for migraine without aura of both sexes, 18-60 year, 50-100 kg.
- •Fertile women should use safe contraception. Fertile women do not include hysterectomized women or women who are postmenopausal for at least 2 years. Safe contraception includes either Intra Uterine Device (IUD), birth control pills, surgical sterilization of the woman or depot progestogen.
排除标准
- •Tension Type headache for more than 5 days the month on average in the last year.
- •All other primary headaches .
- •Headache later than 48 hours before trial start.
- •Daily intake of any medicine other than oral contraception.
- •Ingestion of any form of medicinal product later than 4 times the plasma half-life substance (on trial day), except for oral contraception.
- •Pregnant or breastfeeding women.
- •Headache on the test day or later than 48 hours prior to administration of trial medicine / placebo
- •Migraine within 5 days before the trial date.
- •Ancestral information or clinical signs of (on the day of inclusion):
- •Hypertension (systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 100 mmHg)
- •Hypotension (systolic blood pressure <90 mm Hg and / or diastolic blood pressure <50 mmHg)
- •Cardiovascular disease of all kinds, including cerebrovascular disease.
- •Anamnestic or clinical signs of mental illness or abuse.
- •Patients with glaucoma or prostatic hyperplasia
- •Anamnestic or clinical signs of diseases of any kind such as the investigating physician is considered relevant for participation in the trial.
结局指标
主要结局
Migraine incidence
时间窗: 12 hours
Before (-10 min) and after infusion (+12 hours) of amlyin compared with before and after infusion of CGRP based on questionnaire reported headache and associated symptoms
次要结局
- Dilatation of Arteria radialis and arteria temporalis superficialis(2 hours)
- Headache intensity(12 hours)
- Facial flushing(2 hours)
- Plasma blood samples(2 hours)
研究者
Hashmat Ghanizada, MD
Principal investigator
Danish Headache Center