Amylin-Induced Migraine Attacks Without Aura: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence of migraine attacks without aura
研究概览
简要总结
Pramlintide is a peptide analogue of human amylin which is a vasoactive signaling molecule involved in the pathogenesis of migraine. This study investigates whether pramlintide induces migraine attacks without aura in people with migraine without aura.
详细描述
Amylin is a vasoactive substance that acts on vascular smooth muscle and can cause vasodilation. It is naturally present in the trigeminovascular system, an important structure involved in headache development. Recent studies indicate that intravenous infusion of pramlintide, an amylin analogue, can trigger migraine attacks in people with migraine. This study aims to determine whether intravenous pramlintide can induce migraine attacks without aura in individuals who experience migraine without aura. To test this, the investigators will conduct a randomized, double-blind, placebo-controlled, two-way crossover trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 18 to 65 years of age upon entry into screening
- •A body weight of 50 to 100 kg
- •History of migraine without aura for ≥12 months and in accordance with ICHD-3
- •Between 1-5 monthly migraine days without aura on average across the 3 months prior to screening
- •Provision of informed consent prior to initiation of any study-specific activities/procedures
排除标准
- •Any history of a primary or secondary headache disorder other than migraine without aura and infrequent episodic tension-type headache
- •Any history of moderate to severe traumatic brain injury
- •Any history of cardiovascular disease, including cerebrovascular diseases
- •Any history of pulmonary disease
- •Any other clinically significant disorders, conditions, or diseases that might impact the safety of the subject or interfere with the study's evaluation, procedures, or completion, aside from those mentioned above. This includes any relevant medical history or evidence that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results
- •The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- •Female subjects of childbearing potential with a positive pregnancy test during any study visit
- •Cardiovascular disease of any kind, including cerebrovascular diseases
- •Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
- •Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
- •Abnormalities on the electrocardiogram that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results
- •Daily use of any medication other than contraceptives
- •Intake of any medication other than contraceptives within 48 hours of infusion start
- •Intake of caffeine, nicotine, and alcohol within 12 hours of infusion start
- •Headache of any intensity within 48 hours of infusion start
- •Migraine attack within 48 hours of infusion start
- •Aura within 48 hours of infusion start
研究组 & 干预措施
Placebo
Placebo (isotonic saline) will be administered by intravenous infusion.
干预措施: Placebo (Drug)
Amylin
Pramlintide (Amylin) will be administered by intravenous infusion.
干预措施: Amylin (Drug)
结局指标
主要结局
Incidence of migraine attacks without aura
时间窗: 12 hours
The difference in the incidence of migraine attacks without aura between pramlintide and placebo during the 12-hour observational period after infusion start.
次要结局
- Headache intensity scores(12 hours)
研究者
Håkan Ashina
Associate Professor
Danish Headache Center