The purpose of this study to show that zavegepant 10 milligrams given through the nose provides: * freedom from pain, 2 hours after taking the medicine for the first migraine attack. * consistent freedom from pain, 2 hours after taking the medicine across 4 separate migraine attacks. This study is seeking participants who: * are 18 years of age or older. * have migraine attacks present for at least 1 year with age onset before 50 years old. * have migraine attacks, on average, lasting about 4 to 72 hours if not treated. * have 3 to 8 attacks per month but less than15 headache days per month. If the participant is fit to take part in the study, the participant will receive either the study medicine zavegepant or placebo. A placebo looks like zavegepant but does not contain active ingredients. The study medicine will be given using nasal spray device containing a single amount of zavegepant or matching placebo. The participants will be instructed to take the study medicine at home if participants have a migraine headache which reaches moderate or severe pain intensity. The participants are expected to treat up to 4 migraines of moderate to severe intensity. After taking the study medicine, the participant is not allowed to take any other medications for at least 2 hours after taking the study medicine or placebo. Participant can take other medicines after the 2 hours if the migraine is still present. The participant is expected to record on a paper log all medications taken throughout the study. The study duration is around 26 weeks. This includes a 28-day screening window, up to 20 weeks of treatment period, and a follow up visit at about 4 weeks after taking the study medicine the last time. The participant is expected to come into the study center up to 4 times. There will be up to 3 telephone contacts including one after taking the study medicine the first time or Month 1 whichever comes first, at Month 3 if the participant is still in the study, and a safety follow-up. During the study, the participant is expected to complete two sets of questions in an app on a smartphone. This step is done before and after taking the study medicine. The participants must rate: * Pain * Pain symptoms * How the participants are feeling * General well-being
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
4 doses of zavegpant 10 mg intranasal spray device
3 doses of placebo intranasal spray device and 1 dose of zavegepant 10 mg intranasal spray device
3 doses of placebo intranasal spray device and 1 dose of zavegepant 10 mg intranasal spray device
Comparing efficacy of zavegepant with placebo in the acute treatment of migraine as measured by pain freedom at 2-hours post dose during the Double-Blind Treatment (DBT) Phase.
Pain levels will be assessed on a 4-point scale (0=none, 1=mild, 2=moderate, 3=severe) using an electronic handheld device. Pain freedom is measured as a pain level of none at 2 hours post-dose.
Time frame: 2 hours post-dose
Consistency of efficacy of zavegepant across multiple attacks in the acute treatment of migraine as measured by pain freedom at 2-hours post dose during the DBT Phase.
Freedom from pain response, defined as pain freedom at 2 hours post-dose in ≥2 of 3 qualifying migraine attacks of moderate to severe in intensity.
Time frame: 2 hours post-dose
Percentage of participants with freedom from Most Bothersome Symptoms (MBS) at 2 hours post-dose
Freedom from MBS is defined as the absence of the reported MBS.
Time frame: 2 hours post-dose
Percentage of participants with pain relief at 2 hours post-dose
Pain relief is defined as intensity of none or mild.
Time frame: 2 hours post-dose
Percentage of participants with pain relief at 15 minutes post-dose
Pain relief is defined as intensity of none or mild.
Time frame: 15 minutes
Percentage of participants with consistency of pain relief for at least 2 of 3 qualifying attacks at 2 hours post-dose
Pain relief is defined as intensity of none or mild.
Time frame: 2 hours post-dose
Percentage of participants with return to normal function at 2 hours post-dose
Return to normal function is defined as have a functional status of normal.
Time frame: 2 hours post-dose
Percentage of participants with return to normal function at 30 minutes post-dose
Return to normal function is defined as have a functional status of normal.
Time frame: 30 minutes post-dose
Percentage of participants with sustained pain freedom from 2 to 48 hours post-dose
Pain freedom is measured as a pain level of none. This outcomes measures pain freedom for the duration of 2 to 48 hours post-dose.
Time frame: 2 to 48 hours post-dose
Percentage of participants in the triptan resistant/refractory (TRR) group with pain freedom at the 2 hours post-dose
TRR participants are those that have had inadequate responses from at least 2 different triptans as determined by the principal investigator. Pain freedom is measured as a pain level of none.
Time frame: 2 hours post-dose
Percentage of participants with adverse events (AEs) of moderate or severe intensity
Time frame: Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.
Percentage of participants with serious adverse events (SAEs)
Time frame: Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.
Percentage of participants with local irritation AEs
Time frame: Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.
Percentage of participants with grade 3 or 4 laboratory test abnormalities
Time frame: Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.
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