PHASES: Prodrome in tHe reAl World: aSsESsing Ubrogepant Acute Use
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 189
- 试验地点
- 3
- 主要终点
- Percentage of Participants with Absence of moderate to severe headache over 24 hours post-dose during prodrome.
研究概览
简要总结
Migraine is a neurological disease characterized by moderate or severe headaches, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess changes in migraine attack severity for adult participants treating with oral ubrogepant across migraine attacks.
Ubrogepant is a drug that is approved for the acute treatment of migraine in adults. Approximately 189 participants will be enrolled in approximately 15 sites across the US.
Participants will receive ubrogepant as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 13 weeks.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1
- •-a. Participants with a diagnosis of chronic migraine who report having 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1 due to concomitant preventive treatment are allowed in the study
- •Participant is currently prescribed ubrogepant and has been using ubrogepant for at least 3 months for the acute treatment of migraine in adults, according to the US Food and Drug Administration (FDA)-approved indication
- •Adult participants with current clinical diagnosis of migraine or chronic migraine according to International Classification of Headache Disorders (ICHD)-3
排除标准
- •Currently participating in a concurrent clinical or non-interventional study.
- •Concomitant use with a strong Cytochrome P450 3A4 (CYP3A4 ) inhibitor.
- •Current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia, status migrainosus or painful cranial neuropathy as defined by ICHD-3
研究组 & 干预措施
Ubrogepant
Participants will receive Ubrogepant as prescribed by their physician according to local label.
结局指标
主要结局
Percentage of Participants with Absence of moderate to severe headache over 24 hours post-dose during prodrome.
时间窗: Up to approximately 13 weeks
Prodrome is often the earliest phase of migraine attack and consists of various symptoms including sensitivity to light, fatigue, neck pain, sensitivity to sound, dizziness and difficulty thinking/concentrating.
次要结局
未报告次要终点