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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,414
The participants will receive single active dose sufficient to treat 1 migraine headache of moderate or severe intensity within Treatment Phase.
Single dose of matching placebo taken within Treatment Phase.
The Second People's hospital of Hefei
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Hainan General Hospital
Haikou, Hainan, China
Percentage of participants with pain freedom at 2 hours post dose.
To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from pain.
Time frame: 2 hours post dose
Percentage of participants with an MBS (most bothersome symptom) reported before dosing that is absent at 2 hours post dose.
To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from MBS.
Time frame: 2 hours post dose
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Renmin Hospital Of Wuhan University
Wuhan, Hebei, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Wuhan Third Hospital
Wuhan, Hubei, China
...and 51 more locations