A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Zavegepant Intranasal (IN) for the Acute Treatment of Migraine in Asian Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,414
- 试验地点
- 107
- 主要终点
- Percentage of participants with pain freedom at 2 hours post dose.
研究概览
简要总结
The purpose of this study is to learn how safe and effective zavegepant is compared to placebo in the acute treatment of migraine in Asian adults. Migraine is a very painful headache with other associated symptoms such as nausea, photophobia and phonophobia. A placebo is a harmless treatment that has no medical effect.
This study is seeking for participants who:
- have at least 1 year of migraine history before entering the study.
- have 2 to 8 migraine headache attacks of moderate or severe intensity in each of the 3 months before entering the study.
- have less than 15 days with headaches in each of the 3 months before entering the study. The headaches could be either due to migraine or not.
The participants in this study will receive zavegepant or placebo through intranasal route. Intranasal means medicine which is given through nose. Zavegepant or placebo will be taken if the participants have a migraine headache of moderate or severe intensity.
The study will compare the experiences of people receiving zavegepant to those of the people receiving placebo. This will help see if zavegepant is safe and effective in Asian adults.
Participants will be in this study for up to about 16 weeks. Participants will have 3 study visits at the study clinic and 1 through telephone contact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Asian participants aged 18 years or older at screening.
- •Participants with minimum 1 year history of migraine (with or without aura) prior to the Screening Visit, consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
- •Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
- •Migraine attacks, on average, lasting about 4-72 hours if untreated.
- •Not more than 8 attacks of moderate or severe pain intensity per month within last 3 months.
- •Participants must be able to distinguish migraine attacks from tension/cluster headaches.
- •At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
- •Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
- •Participants on prophylactic migraine medication are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to Screening Visit, and if the dose is not expected to change through the End of Treatment Visit.
- •Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
排除标准
- •History of retinal migraine, basilar migraine or hemiplegic migraine.
- •History or current evidence of uncontrolled, unstable or recently diagnosed cardiovascular or cardiometabolic disease.
- •Major depressive disorder, anxiety disorder, or other significant psychiatric disorder.
- •Acute or chronic pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that interfere with study assessments.
- •Conditions that may affect the administration or absorption of the nasal product.
- •Medication overuse headaches.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Zavegepant
Zavegepant intranasal 10 mg
干预措施: Zavegepant (Drug)
结局指标
主要结局
Percentage of participants with pain freedom at 2 hours post dose.
时间窗: 2 hours post dose
To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from pain.
Percentage of participants with an MBS (most bothersome symptom) reported before dosing that is absent at 2 hours post dose.
时间窗: 2 hours post dose
To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from MBS.
次要结局
未报告次要终点