Randomized Double-Blind Study to Evaluate the Dose-Related Efficacy and Safety of Caffeine/Propranolol in the Treatment of Acute Migraine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Participants Reporting Pain Relief at 2 Hrs Post First Administration of Caffeine/Propranolol (Defined as a Decrease in Headache Pain Intensity From Severe or Moderate Headache Pain at Baseline to Mild or no Pain at 2 Hrs)
研究概览
简要总结
This is a research study to assess the safety of caffeine/propranolol at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their migraines.
详细描述
There will be a screening exam to find out if potential subjects are eligible to be in the main part of the study. Screening will include obtaining demographics, migraine history, migraine characteristics, verification that subjects's migraine satisfies the International Headache Society criteria, migraine medication history with success and failure rates, and medical history.
If a subject is female, we will need to confirm to the extent medically possible that they are not pregnant. Female subjects must agree to have a urine pregnancy test done before beginning this research study. If a subject is a woman who is able to become pregnant, it is expected that they will use an effective method of birth control to prevent exposing a fetus to a potentially dangerous agent with unknown risk. They must accept the risk that pregnancy could still result despite the responsible use of reliable method of birth control.
They agree to notify Dr. Cho as soon as possible of any failure of proper use of your birth control method, or if you become pregnant, either of which may result in your being withdrawn from the study.
Subjects will also undergo a liver function test as well as an EKG to make sure they are eligible for the study.
Once subject eligibility has been determined, they will be randomized to one of 3 study groups described below. Neither the subjects nor the doctor can choose which group subjects will be in nor will subjects or their doctor know which group subjects are in. They will have a one in three chance of being placed in any group. Two groups will be active treatment with either 400 mg caffeine and 40 mg propranolol or 1000 mg caffeine and 40 mg propranolol. The third group will be a placebo group with no active medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has a minimum 12-month migraine history that the investigator determines meets the International Headache Society (IHS) Migraine Diagnostic Criteria for migraine with or without aura
- •Subject is between 18-50 years of age.
- •Subject experiences an average of 2-8 migraines per month.
- •If on preventive migraine therapy, medication regimen has been stable for 30 days and will remain stable for the duration of participation.
- •Subject is able to communicate adequately and comply with the requirements of the study as determined by the investigator.
- •Subject is able to read and understand the informed consent written in English and voluntarily consents to sign the informed consent form.
排除标准
- •Subject#s age of migraine onset is greater than 50 years.
- •Subject has more than 6 non-migraine headache days per month.
- •Subject has less than 48 hours of freedom from headache between attacks of migraine.
- •Subject meets the criteria for complicated and/or brainstem migraines.
- •Subject is pregnant or lactating.
- •Subject has history of alcohol or drug abuse within the past 2 years.
- •Subject has existing systolic blood pressure < 100mm Hg, existing systolic blood pressure > 150mm Hg, and or heart rate <50 beats per minute.
- •Subject has heart block greater than 1st degree without a functioning pacemaker
- •Subject has a history of tachyarrythmias
- •Subject has uncompensated congestive heart failure (CHF)
- •Subject has severe chronic obstructive pulmonary disease or severe asthma.
- •Subject has consumed caffeine within 6 hours.
- •Subjects with existing generalized anxiety disorder (GAD) and/or panic disorder.
- •Subjects with existing severe hepatic and/or renal insufficiency.
- •Subjects with existing Raynaud#s disease.
- •Subject is participating in another clinical trial during or within 30 days prior to study enrollment.
研究组 & 干预措施
Placebo
Participants will receive placebo to match caffeine/propranolol (single dose)
干预措施: placebo (Drug)
Low dose
Participants will receive caffeine/propranolol 400/40 mg combination tablet (single dose)
干预措施: caffeine/propranolol combination tablet (Drug)
High dose
Participants will receive caffeine/propranolol 1000/40 mg combination tablet (single dose)
干预措施: caffeine/propranolol combination tablet (Drug)
结局指标
主要结局
Percentage of Participants Reporting Pain Relief at 2 Hrs Post First Administration of Caffeine/Propranolol (Defined as a Decrease in Headache Pain Intensity From Severe or Moderate Headache Pain at Baseline to Mild or no Pain at 2 Hrs)
时间窗: 2 hours
次要结局
- Percentage of Participants Pain Free at 2 Hrs Post First Administration of Caffeine/Propranolol(2 hours)
- Percentage of Participants With Treatment Satisfaction(24 hours)
- Percentage of Participants Experiencing at Least One Adverse Event of Interest(24 hours)
研究者
S. Charles Cho
Principle Investigator
Stanford University