An Evaluation of Treximet in the Treatment of Acute Migraine Headache: A Placebo-Controlled, Double-Blind, Crossover Study, Assessing Cognitive Function.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache on the neuropsychological function before treatment and at one and two hours after treatment of a migraine.
研究概览
简要总结
Migraine headache occurs frequently in women more than men and is associated with symptoms not only of significant pain but also of symptoms typically including of photophobia, phonophobia, nausea and vomiting. Many migraine patients report difficulty in cognition from lack of concentration, difficulty in word finding or inability to remember. Many of these cognitive symptoms seem to be independent of the pain intensity and may occur completely separately from the headache pain but can be disabling. It is likely that the frequency and importance of cognitive symptoms associated with migraine are underreported.
The Mental Efficacy Workload Test (MEWT) is a computerized battery that is designed to be an efficient and accurate measure of cognition during migraine headache. Treximet is a new migraine treatment recently FDA approved for the treatment for the relief of acute migraine that may be effective for the cognitive symptoms for migraine patients who have a history of cognitive dysfunction during a migraine headache. The primary efficacy parameter is to evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache measuring neuropsychological function using the MEWT during the migraine and comparing that score with a prior MEWT score when the patient had no migraine symptoms. A double blind, placebo-controlled, crossover study was chosen so that each patient may be her or his own control.
It is the intent of this study to determine the type and intensity of cognitive dysfunction associated with migraine headache and to what extent that Treximet may relieve the cognitive dysfunction in a safe and effective manner.
详细描述
Overall Study Design:
This study is to be a double blind crossover comparison study in patients during a migraine headache attack, with assessments at one and two hours after treatment. Patients with an IHS diagnosis of migraine with or without aura may be included. The patients will complete a questionnaire regarding the nature of their migraine attacks, including their impression of cognitive impairment if any. Historically associated symptoms will be listed. Menstrual associated migraine history will be assessed. 30 patients will be randomized to Treximet or placebo in a 1:1 manner for the first treatment and in reverse order for treatment on the second migraine attack. In this manner, each patient will be his or her own control. 60 migraine headaches will be treated in this study. Also, it has been previously discussed that after 3 practice sessions with the MEWT, further administration of the MEWT does not produce bias by a practice effect as the ANAM has been shown not to produce bias by a practice effect.10 Therefore, patients will have 3 practice sessions in the clinic before taking the baseline MEWT.
During the baseline period, while the patient is without any migraine symptoms and feeling well (interictal period), three practice trials on the MEWT will be performed and a fourth MEWT trial will be taken with the score recorded for a neuropsychological baseline. When the patient experiences a migraine headache, the patient will rate headache severity and associated symptoms and then take Treximet or matching placebo. The patient will repeat headache and associated symptom checklist and the MEWT at 1 and 2 hours after treatment. Rescue medication will be allowed at 2 hours for those patients who require it.
4.0 Clinical Methods:
4.1 Selection of Study Population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
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
- •Females and male subjects, ages 18-65 inclusive
- •Have migraines with or without aura as expressed by the International Headache Society (IHS) criteria for at least six months and at least one attack per month for three months prior to screening
- •If female, have an acceptable method of contraception during the study, have no plans to become pregnant and have a negative urine pregnancy test at screening and throughout the study.
- •Must be able to follow study protocol including all neuropsychological testing, MEWT assessments and evaluation forms.
- •Must be willing and able to provide written informed consent
排除标准
- •Have more than 15 headache days per month
- •Have hemiplegic or secondary headaches
- •Have significant risk factors for cardiovascular or cerebrovascular disease as assessed by the investigator
- •Are taking any medication that is contraindicated with a triptan or NSAIDs
- •Have any significant concomitant disease
- •Have any allergy to triptans, aspirin or NSAIDs
- •Have a history of substance abuse, psychiatric illness in the last 5 years
- •Are participating or have participated in an investigational drug trial within the last 30 days
研究组 & 干预措施
1
Treximet, cognitive testing
干预措施: Treximet (Drug)
2
Placebo, Cognitive testing
干预措施: Migraine rescue medication of choice (Drug)
结局指标
主要结局
To evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache on the neuropsychological function before treatment and at one and two hours after treatment of a migraine.
时间窗: 2 hours post dose
次要结局
- To assess incidence and types of neuropsychological deficits by MEWT in patients with acute migraine headache before treatment.(2 hours post dose)