NCT00904098已完成4 期
Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment)Of Menstrual Migraine
Endo Pharmaceuticals0 个研究点目标入组 192 人开始时间: 2005年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 主要终点
- Headache pain severity
研究概览
简要总结
Females 18 years of age or older with at least one year history of menstrual migraine (MM) headaches participated in a Phase 4 clinical trial to evaluate the efficacy of frovatriptan when used at the early stage (International Headache Society [IHS] Grade 1) of MM compared with patients' current treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Had MM headaches occurring between Day -2 and Day +3 of menses
- •Had at least one year history of MM headaches
- •Had at least 8 MM headaches in the previous 12 menstrual cycles (1 year)
- •Had regular predictable menstrual periods (28 ± 4 days)
排除标准
- •Had a history of more than 15 headache days per month
- •As part of current MM treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of MM)
- •Had a history of myocardial infarction, ischemic heart disease (or presented with symptoms or signs compatible with ischemic heart disease), coronary vasospasm (including Prinzmetal's variant angina), other significant underlying cardiovascular disease, or peripheral vascular disease
- •Had significant cerebrovascular disease, including basilar or hemiplegic migraine
- •Had uncontrolled hypertension: systolic blood pressure >180mmHg and diastolic blood pressure >95mmHg
- •Had severe hepatic or renal insufficiency
- •Used an analgesic medication (including both prescription and over-the-counter) for any reason >50% of days per month
研究组 & 干预措施
Frovatriptan
Experimental
Frovatriptan 2.5 mg oral tablet
干预措施: Frovatriptan (Drug)
Usual Care
Active Comparator
Usual care includes the current treatment used to treat all episodes of migraine headache
干预措施: Usual Care (Drug)
结局指标
主要结局
Headache pain severity
时间窗: Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)
次要结局
- Occurrence and severity of MM symptoms associated with migraine headache pain (nausea, vomiting, photophobia, and phonophobia)
- Occurrence and severity of functional impairment during menstrual migraine
- Use of rescue medication and additional frovatriptan dose
- Patient satisfaction with treatment
- Patient preference of current vs. study treatment (end of study only)
- Safety as assessed by occurrence of AEs
研究者
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