NCT00725140已完成不适用
Standardized sTudy With Almotriptan in eaRly Treatment of Migraine, START. An International, Open-label, Single Arm, Effectiveness and Safety Study of Almotriptan in Primary Care Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 3
- 主要终点
- Pain Free
研究概览
简要总结
This is a observational, open, prospective, single arm cohort study within authorized SPC conditions to describe the effectiveness of Almotriptan in treating acute migraine attacks when pain is mild and in the first hour of pain in everyday primary care clinical practice.
详细描述
Primary Objective:
To describe the effectiveness of Almotriptan in treating acute migraine attacks when pain is mild and in the first hour of pain in everyday primary care clinical practice.
Secondary Objectives:
- Influence of an educational intervention on the early intake of the treatment
- Influence of medication history or concomitant medication on treatment results
- Influence of migraine triggers on treatment results
- Influence of stress on treatment results
- Tolerability profile validation
- Patients' satisfaction
- Reasons for delaying migraine treatment intake
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •History of a confirmed diagnosis of migraine that meets the IHS diagnosis criteria of migraine with or without aura for at least one year.
- •Patients with a history of migraine headaches progressing from mild to at least moderate pain intensity if untreated on a scale of no pain (0), mild (1), moderate (2), or severe (3) within the past year.
- •Migraine headache frequency of 2 to 6 per month for the past 3 months.
- •Male or female aged 18 to 65 years.
- •Able to differentiate a migraine headache from an interval (e.g., tension-type) headache.
- •8.Female patients of childbearing potential must not suspect to be pregnant and have an effective method of birth control for at least 30 days prior to study entry and throughout the study.
- •11.After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.
- •12.Patients must either use Almotriptan for their migraine acute attacks treatment or prove through the ANAES scale in the basal visit that a change in their treatment approach is required.
排除标准
- •Patients, who in the opinion of the investigator, should not be enrolled in the study because of the precautions, warnings or contraindications sections of the Almotriptan Summary of Product Characteristics.
- •Patients who have had 15 or more headache days per month in the previous 6 months (chronic daily headache), or patients having a migraine headache frequency of more than 6 per month for the past 3 months.
- •Patients with onset of migraine after age
- •Patients who routinely experience any other type of headache that would confound discrimination from a migraine.
- •Patients who have exclusively migraine aura without headache.
- •Patients who typically experience vomiting with their headaches.
- •Patients with hemiplegic or basilar type migraines.
- •Patients who typically have headaches that occur predominantly upon awakening in the morning.
- •Patients who have previously discontinued Almotriptan therapy due to an adverse event or lack of efficacy.
- •11.Patients taking any of the prohibited concomitant medications listed in Section 10.3.1 of the protocol.
- •12.Patients who have used any of the following medications within 7 days of study entry and during the trial: sustained release opioids and/or semi-synthetic or long acting opioids.
- •16.Women who are pregnant or lactating.
- •18.Patients who have received an investigational drug or used an investigational device within 30 days of study entry.
结局指标
主要结局
Pain Free
时间窗: 2 h from intake
次要结局
- Sustained Pain Free(24 h)
- SNAE (Sustained pain free and No Adverse Events)(24 h)
- Time loss (functional disability)(24 h)
- Consistency of response to treatment between attacks (2 h PF in 2/3 attacks)(2 months)
- Associated symptoms presence evolution: Nausea, Vomiting, Photophobia, Phonophobia.(Basal - 2h - 24h)
- Migraine attack duration(24 h)
- Adverse Events(From recruitment to study end or AE resolution)
- Second tablet / rescue medication use(24 h)
- Relapse(24 h)
- Patients' satisfaction:(Basal - After each attack)
研究者
研究点 (3)
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