NCT03471039已完成不适用
Pituitary Adenylate Cyclase-activating Polypeptide (PACAP27) Headache Properties in Migraine Without Aura Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Headache Scores
研究概览
简要总结
Pituitary adenylate cyclase-activating polypeptide (PACAP) is a signaling molecule, localized in sensory and parasympathetic perivascular nerves fibres. PACAP exists i to functional iso-forms Pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and PACAP27.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, 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.
研究组 & 干预措施
Active
Active Comparator
PACAP-27
干预措施: PACAP27 (Drug)
Placebo
Placebo Comparator
Saline
干预措施: Saline (Drug)
结局指标
主要结局
Headache Scores
时间窗: 0-12 hours
Comparison between PACAP27 and Placebo
次要结局
- Facial blood flow (flushing)(0-120 mins)
研究者
Hashmat Ghanizada
Principal Investigator
Danish Headache Center
研究点 (1)
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