Investigation of PACAP38-induced Headache and Rosacea-like Symptoms in Patients With Rosacea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Incidence of headache and migraine
研究概览
简要总结
The investigators aim is to investigate the incidence of headache and rosacea-like flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatriptan in patients with rosacea
详细描述
Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in rosacea pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in migraine patients. PACAP38 also induces flushing which may imitate rosacea-like flushing. We are investigating whether the flushing after PACAP38 resembles rosacea-like flushing, and whether treatment with sumatriptan has an effect on the headache and flushing effects of PACAP38.
The purpose of this study is to investigate PACAP38-induced headache and flushing in patients with rosacea who have been treated with either sumatriptan or placebo using purpose-developed standardized interview. The investigators will use a double-blind, placebo-controlled crossover study design to investigate this.
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
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with rosacea
- •weight between 50 - 100 kilograms
- •women in fertile age must not be pregnant and must use adequate contraception
排除标准
- •migraine more than 5 days per month in average over the past year
- •any primary headache other than migraine, apart from tension-type headache which must be less than 5 days per month
- •headache < 48 hours before experimental day
- •migraine < 72 hours before each experimental day
- •daily / frequent use of any medication apart from contraceptive medication
- •use of any drug less than 5 times the half-life of the drug at the time of the experiment
- •women who are pregnant or breast-feeding at the time of the experiment
- •anamnestic or clinical signs of hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) or hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
- •anamnestic or clinical signs of mental illness, or abuse of alcohol / drugs
- •patients with glaucoma or prostate hyperplasia
- •anamnestic or clinical symptoms of any sort that the investigating doctor deemed unfit for participating in the study
研究组 & 干预措施
PACAP38 + Imigran
Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins
AND
Imigrane infusion (0.4 mg/min) for 10 mins
干预措施: Imigran (Drug)
PACAP38 + Isotonic Saline
Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins
AND
Isotonic saline for 10 mins (placebo)
干预措施: Isotonic Saline (Other)
结局指标
主要结局
Incidence of headache and migraine
时间窗: From 0 to 24 hours after infusion
Incidence of PACAP38-induced headache and migraine-like attacks in patients with rosacea measured by numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable") and international classification for migraine.
Effect of sumatriptan
时间窗: From 0 to 24 hours after infusion
Severity of PACAP38-induced headache after pretreatment with sumatriptan in rosacea patients measured by numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable")
次要结局
- Severity of flushing(From 0 to 4 hours after infusion)
- Facial temperature(From 0 to 4 hours after infusion)
- Superficial temporal artery diameter(From 0 to 4 hours after infusion)
研究者
Nita Katarina Frifelt Wienholtz
Principal Investigator, Medical Doctor, PhD Student
Danish Headache Center