A Multicenter, Open-label Evaluation of Treatment Satisfaction, Tolerability, Safety and Preference for Sumavel DosePro for Treatment of Migraine in Subjects Currently Treated With Triptans
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 42
- 主要终点
- Overall Satisfaction
研究概览
简要总结
The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.
详细描述
Single arm, open-label, multicenter study to evaluate the treatment satisfaction, treatment confidence, and subject preference for Sumavel DosePro in adult subjects diagnosed with migraines and currently treated with triptans. Subjects will treat up to 4 migraines over a 60 day period and complete migraine diaries and questionnaires.
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
- •History of 2 to 6 migraine headaches per month
- •Migraines should have been present for at least 1 year with age at onset of migraine less than 50 years
- •History of 24 hours of freedom between migraine attacks
- •Current users of triptan medications
- •Able to distinguish interval or other non-migrainous headaches from typical migraine
- •General good health
排除标准
- •History or symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes
- •Significant underlying cardiovascular diseases including uncontrolled hypertension
- •Hemiplegic or basilar migraine
- •History or diagnosis of severe hepatic or renal impairment
- •History of epilepsy or seizure or other serious neurologic condition
- •History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs including sulphonamides
- •History of scleroderma (systemic sclerosis)
- •Pregnant or breastfeeding
- •Use of contraindicated prescription medications, monoamine oxidase inhibitors (MAO-A), selective serotonin reuptake inhibitors, or lithium agents
研究组 & 干预措施
Sumavel(R) DosePro(R)
Single arm study (Sumavel DosePro)
干预措施: Sumatriptan (Drug)
Sumavel(R) DosePro(R)
Single arm study (Sumavel DosePro)
干预措施: Sumavel DosePro (Device)
结局指标
主要结局
Overall Satisfaction
时间窗: After 4 migraines or 60 days
Change from baseline in overall subject satisfaction with migraine treatments. Patient Perception of Migraine Questionnaire-Revised, question 3c "Overall satisfaction" was the measure. Baseline measured subjects satisfaction with past migraine treatments. End of study measured subject's satisfaction with migraine treatment by Sumavel DosePro. PPMQ-R scale (1-7 scale; 1=very satisfied)is transformed to a 0-100 scale (100=very satisfied)
次要结局
- Treatment Preference(After 4 migraines or 60 days)
- Treatment Confidence(After 4 migraines or 60 days)