| Primary | Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose. | Efficacy Analysis Participants included treated participants who were randomized only once, had moderate to severe pain at the time of dosing, and had non-missing, post-dose efficacy data. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00023.6(20.3 to 26.9)
- OG00114.9(12.1 to 17.6)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Cochran-Mantel-Haenszel | | <0.0001 | Threshold for significance at 0.05. | Stratified Percentage Difference | 8.8 | | | 2-Sided | 95 | 4.5 | 13.1 | | | | | Superiority | The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05. | |
|
| Primary | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | MBS was reported as nausea, photophobia, or phonophobia immediately before dosing using the eCOA handheld device. Symptom status (absent, present) was assessed post-dose using the eCOA handheld device separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at on-study migraine attack onset that was absent post-dose. | Efficacy Analysis Participants included treated participants who were randomized only once, had moderate to severe pain at the time of dosing, and had non-missing, post-dose efficacy data. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants With Pain Relief at 2 Hours Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild. | Efficacy analysis participants were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose | Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset. | The Efficacy Analysis Participants with functional disability at the time of dosing were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose. | Efficacy analysis participants were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 2 to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose. | Efficacy analysis participants were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 2 to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose. | Efficacy analysis participants were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 2 to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose. | Efficacy analysis participants were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 2 to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose | Phonophobia (sensitivity to sound) status was measured as absent or present in the eCOA handheld device. Freedom from phonophobia was defined as phonophobia absent post-dose in the subset of participants with phonophobia present at on-study migraine attack onset. | Efficacy Analysis Participants with symptom of phonophobia present at the time of dosing were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose | Photophobia (sensitivity to light) status was measured as absent or present in the eCOA handheld device. Freedom from photophobia was defined as photophobia absent post-dose in the subset of participants with photophobia present at on-study migraine attack onset. | Efficacy Analysis Participants with symptom of photophobia present at the time of dosing were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants With Pain Relief at 60 Minutes Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild. | Efficacy analysis participants were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 60 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose | Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) present at on-study migraine attack onset. | The Efficacy Analysis Participants with normal function at the time of dosing were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 60 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants With Pain Relief at 30 Minutes Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild. | Efficacy analysis participants were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 30 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose | Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset. | The Efficacy Analysis Participants with normal function at the time of dosing were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 30 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants With Pain Relief at 15 Minutes Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild. | Efficacy analysis participants were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 15 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose | Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset. | The Efficacy Analysis Participants with normal function at the time of dosing were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 15 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose | Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eCOA handheld device) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin® Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (for example, metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the site on a case report form. | Efficacy Analysis Participants were analyzed. Participants with rescue medication start date less than or equal to (≤) study drug start date + 1 day and missing rescue medication start time were excluded. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Through 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
|
| Secondary | Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose | Nausea status was measured as absent or present in the eCOA handheld device. Freedom from nausea was defined as nausea absent post-dose in the subset of participants with nausea present at on-study migraine attack onset. | The Efficacy Analysis Participants with symptom of nausea present at the time of dosing were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |
| Secondary | Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose in the subset of participants with pain level of none at 2 hours post-dose. | The Efficacy Analysis Participants with pain freedom at 2 hours post-dose were analyzed. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 2 hours to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant 10 mg | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. | | OG001 | Placebo | Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. |
| |