Hypersensitivity to Adrenomedullin in Post- Traumatic Headache: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence of headache with migraine-like features
研究概览
简要总结
Adrenomedullin is a neuropeptide implicated in the pathogenesis of headache. This study investigates whether adrenomedullin induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).
详细描述
Adrenomedullin is a potent vasoactive peptide that acts on the vascular smooth muscle and is known to induce vasodilation. It is endogenously expressed in the trigeminovascular system, a key anatomical substrate involved in headache pathogenesis. Evidence suggests that individuals with persistent post-traumatic headache (PTH) frequently experience headache with migraine-like symptoms. This study investigates whether intravenous infusion of adrenomedullin can provoke migraine-like headache in individuals with persistent PTH attributed to mild traumatic brain injury. To test this hypothesis, the investigators will carry out 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
- •History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
- •≥ 4 monthly headache days 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
- •> 1 mild traumatic injury to the head
- •History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)
- •History of moderate or severe injury to the head
- •History of whiplash injury
- •History of craniotomy
- •History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
- •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)
- •Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion
- •Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start
- •Baseline headache intensity of >3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache)
- •Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features
研究组 & 干预措施
Adrenomedullin
Adrenomedullin will be administered by intravenous infusion.
干预措施: Adrenomedullin (Drug)
Placebo
Placebo (isotonic saline) will be administered by intravenous infusion.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of headache with migraine-like features
时间窗: 12 hours
The difference in incidence of headache with migraine-like features between adrenomedullin and placebo during the 12-hour observational period after infusion start.
次要结局
- Headache Intensity Scores(12 hours)
研究者
Haidar Al-Khazali
Sub-Investigator
Rigshospitalet, Denmark