Hypersensitivity to Amylin in Post-Traumatic Headache: 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-like headache
研究概览
简要总结
Pramlintide is a peptide analogue of human amylin which is a vasoactive substance involved in the pathogenesis of headache. This study investigates whether pramlintide induces migraine-like headache in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).
详细描述
Amylin is a vasodilator released from nerve fibers within the trigeminovascular system, which is considered a key anatomical and physiological substrate in the pathogenesis of migraine and persistent post-traumatic headache (PTH). Persistent PTH attributed to mild traumatic brain injury frequently presents with migraine attacks, suggesting shared underlying mechanisms with migraine. This study aims to determine whether intravenous infusion of pramlintide, an analogue of amylin, can induce migraine-like headache in individuals with persistent post-traumatic headache. To test this hypothesis, we will conduct a randomized, double-blind, placebo-controlled, two-way crossover study.
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 migraine-like headache or self-reported baseline headache that mimics the subjects' usual migraine-like headache
研究组 & 干预措施
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-like headache
时间窗: 12 hours
Difference in incidence of migraine-like headache (0 to 12 hours) between pramlintide and placebo.
次要结局
- Headache Intensity Scores(12 hours)
研究者
Ksenija Cucanic
PhD Fellow
Danish Headache Center