NCT05595993招募中不适用
Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache: A Randomized Clinical Trial
适应症
干预措施
相关药物
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 Migraine-Like Headache
研究概览
简要总结
To investigate whether cilostazol (phosphodiesterase 3 inhibitor) induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).
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
Cilostazol
Experimental
Oral administration of 200 mg cilostazol.
干预措施: Cilostazol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Migraine-Like Headache
时间窗: 12 Hours
Difference in incidence of headache with migraine-like features (0 to 12 hours) between cilostazol and placebo.
次要结局
- Headache Intensity Scores(12 Hours)
研究者
Håkan Ashina
MD
Danish Headache Center
研究点 (1)
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