Sumatriptan as Treatment for Moderate to Severe Post-Traumatic Headache
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Headache Relief
研究概览
简要总结
This phase II evaluation of sumatriptan as a treatment for post traumatic headache (PTH) will examine the methods and approach necessary to take the next step to a phase III trial. The sample will include 40 persons with mild complicated, moderate or severe TBI who will be recruited from patients discharged from the acute rehabilitation unit as well as outpatient clinics and the community who are between 3 and 24 months of injury and will be followed over 3 months. The investigators plan to enroll those who have moderate to severe headache with frequency of at least four and up to a maximum of fifteen total headache days per month and at least three months after discharge from hospital. The investigators will use headache diaries to track the headaches for a month. If subjects still have significant headache, the investigators will instruct them in the use of sumatriptan 100 mg. to treat headaches. The subjects will continue to keep daily headache diaries. The investigators will evaluate them at baseline, Day 30 and Day 90. Each subject will receive weekly telephone follow up calls from the research staff. The investigators will measure pain severity, duration, recurrence of headaches, and side effects and how well persons with TBI can use headache diaries.
详细描述
I. Specific Aims of Study: The ultimate aim of this Phase II open-label study is to test the research methods and approach necessary to successfully carry out a Phase III study for the treatment of post-traumatic headache (PTH). During this study, we will
- Determine the feasibility of using a headache diary accessed via smart phone application, the web, or paper/pencil to record accurate headache data in a group of individuals with TBI, and their caregivers as indicated.
- Evaluate the approximate effect size of sumatriptan on pain severity, duration, and recurrence of headaches in persons with moderate to severe PTH in order to establish the necessary sample size for a Phase III study.
- Assess the side effect profile of sumatriptan in a brain-injured population as well as the safety of sumatriptan in subjects with TBI.
- Evaluate the ability of persons with TBI, and their caregivers as indicated, to successfully use abortive headache medications and comply with treatment.
- Examine the relationship between PTH and cognitive, emotional, and other self-report measures to determine important factors to include in a Phase III study.
This is a single arm, unblinded study enrolling 40 subjects and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with mild complicated, moderate or severe TBI in preparation for a subsequent Phase III study.
Data collection will occur at enrollment (Clinic Visit 1) at which baseline testing will occur, Day 30 (Clinic Visit 2), and Day 90 (Clinic Visit 3).
Pre-treatment Visit (Visit 1): Subjects who complete informed consent and meet the inclusion criteria (with no exclusion criteria) will be asked to complete 30 days of headache diary to document the number of headaches, headache severity, headache days and description of their headache and associated symptoms. Research staff will contact them on a weekly basis to answer questions and maximize accuracy and compliance with the diary. Proper utilization of a headache diary and success of data input by the subject and caregiver will be evaluated following weekly interviews with the research assistant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The lower age limit is set for ability to consent as an adult for research participation as well as being a minimum age for administration of most validated outcome measurements. The higher age limit is set to 65 to reduce likelihood of health issues which may be a contraindication to the use of sumatriptan and to meet recommendations by the International Headache Society.62
- •Diagnosis of TBI occurring at least 3 months but not greater than 60 months before enrollment. Three months was chosen to include only those subjects who are having headache beyond their acute injury and 60 months to identify the ability of individuals with TBI and headache to use both a headache diary and the medication.
- •Subject has at least four and up to a maximum of fifteen total headache days per month. Subject report of meeting this criteria will result in the subject entering the first month of the study. However, this frequency must be documented in headache diary to enter the treatment phase of the study.
- •Headaches are classified as moderate to severe (2 or 3 on the 4 point pain scale: 0=no headache, 1=mild headache, 2=moderate headache, 3=severe headache). As above, headache severity must be documented in the month-long headache diary prior to entry into the treatment phase.
- •Subject is able and willing to give written informed consent for participation in screening activities and to participate fully in the study if eligible. For those subjects who score below 25 on the Mini Mental Status Examination, there must be a caregiver willing to also be consented for participation in the study.
- •Female subjects of childbearing potential must have a negative pregnancy test at enrollment, and agree to remain abstinent or use acceptable methods of birth control (i.e., hormonal contraceptives, intrauterine device, diaphragm with spermicide, cervical cap or sponge, condoms, or partner has had a vasectomy). Sumatriptan has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of decreased fetal body weight, embryo lethality, and cervicothoracic vascular defects. There are no controlled data in human pregnancy and therefore, sumatriptan should only be given during pregnancy when benefit outweighs risk.
排除标准
- •History of ischemic heart disease (angina pectoris, history of myocardial infarction, silent ischemia, Prinzmetal's angina/coronary vasospasm, ischemic bowel disease, or peripheral vascular disease) based on self-report or history of basilar or hemiplegic migraine.
- •Uncontrolled hypertension at initial visit (sitting systolic pressure > 140 mm Hg, diastolic pressure > 90 mm Hg).
- •Impaired renal or liver function by medical history.
- •Subject has taken an MAO inhibitor within 2 weeks of screening because these drugs and sumatriptan use the same metabolic pathway.
- •Subject has hypersensitivity reactions or other intolerance to sumatriptan or any other 5-HT 1B/1D-receptor agonists.
- •If subjects have medication overuse headache in the opinion of the investigator (if using medication to treat acute headache on more than 15 days per month).
- •Inability to speak or read English which would limit ability to interact with examiners and complete headache diary and other questionnaires during this study.
研究组 & 干预措施
Sumatriptan
Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary.
干预措施: Sumatriptan 100 mg (Drug)
结局指标
主要结局
Change in Headache Relief
时间窗: 1 month
percent of headaches that had complete resolution (pain free at 2 hours) for each person, during the initial (pre-intervention) month when they used their regular treatment and during the second of the two months (intervention) when they treated headaches with sumatriptan compared using a mixed-effects regression model. Reported number is the difference in headache resolution from the pre-intervention headaches to the intervention headaches.
次要结局
- Adverse Events(2 months)
- Sumatriptan Compliance(1 month)
- Headache Diary Compliance(1 month)
研究者
Jeanne Hoffman
Professor- Rehabilitative Medicine: Psychology
University of Washington