| Primary | Percentage of Participants With Pain Freedom at 2 Hours Post-dose | Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). | Efficacy analysis set included all enrolled participants, who (1) were randomized only once, (2) had a migraine of moderate or severe pain intensity at the time of dosing, (3) took study intervention (Zavegepant or Placebo), and (4) had post-dose efficacy data. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00023.2(20.0 to 26.4)
- OG00114.1(11.4 to 16.7)
|
|
| | 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 |
|---|
| | Mantel Haenszel | | <0.0001 | | Difference in Percentage | 9.2 | | | 2-Sided | 95 | 5.0 | 13.3 | | | The difference (Zavegepant-Placebo) was estimated based on Mantel-Haenszel risk estimation stratified by country/region. Corresponding confidence interval (CI) and p-value were calculated based on normal approximation. | | Superiority | | |
|
| Primary | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | MBS was selected from nausea, phonophobia or photophobia before dosing by the participants. In this outcome measure, percentage of participants who recorded an MBS (present) before dosing and did not have the MBS (absent) at the time of evaluation (i.e., 2 hours post-dose) were reported. | Efficacy analysis set was evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants With Pain Relief at 15 Minutes Post-dose | Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). | Efficacy analysis set was evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 15 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants With Pain Relief at 30 Minutes Post-dose | Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). | Efficacy analysis set was evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 30 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants With Pain Relief at 2 Hours Post-dose | Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). | Efficacy analysis set was evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants Who Returned to Normal Function at 2 Hours Post-dose | Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 2 hours post-dose) were reported. | The participants with functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing in efficacy analysis set were evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose | Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). This outcome of sustained pain relief was defined as pain intensity being mild or none at all time points from 2 to 24 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose. | Efficacy analysis set was evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 2 hours post-dose to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose | Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). This outcome of sustained pain relief was defined as pain intensity being mild or none at all time points from 2 to 48 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose. | Efficacy analysis set was evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 2 hours post-dose to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants Who Returned to Normal Function at 30 Minutes Post-dose | Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 30 minutes post-dose) were reported. | The participants with functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing in efficacy analysis set were evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 30 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants Who Returned to Normal Function at 60 Minutes Post-dose | Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 60 minutes post-dose) were reported. | The participants with functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing in efficacy analysis set were evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 60 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose | Freedom from phonophobia was defined as phonophobia absent at specified time point for participants with the phonophobia present at the time of dosing. In this outcome measure, percentage of participants who had phonophobia at the time of dosing and then recorded phonophobia absent at the time of evaluation (i.e., 2 hours post-dose) were reported. | The participants who had phonophobia (present) at the time of dosing in efficacy analysis set were evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose | Freedom from photophobia was defined as photophobia absent at specified time point for participants with the photophobia present at the time of dosing. In this outcome measure, percentage of participants who had photophobia at the time of dosing and then recorded photophobia absent at the time of evaluation (i.e., 2 hours post-dose) were reported. | The participants who had photophobia (present) at the time of dosing in efficacy analysis set were evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose | Freedom from nausea was defined as nausea absent at specified time point for participants with the nausea present at the time of dosing. In this outcome measure, percentage of participants who had nausea at the time of dosing and then recorded nausea absent at time of evaluation (i.e., 2 hours post-dose) were reported. | The participants who had nausea (present) at the time of dosing in efficacy analysis set were evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose | Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). Sustained pain freedom was defined as pain intensity being none at all time points from 2 to 24 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose. | Efficacy analysis set was evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 2 hours post-dose to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose | Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). Sustained pain freedom was defined as pain intensity being none at all time points from 2 to 48 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose. | Efficacy analysis set was evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 2 hours post-dose to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants With Pain Relapse at Any Time Point After 2 Hours Post-dose to 48 Hours Post-dose | Pain relapse was defined as pain intensity of mild, moderate, or severe at any time point after 2 hours to 48 hours post-dose for participants with pain intensity of none at 2 hours post-dose. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). | The participants with pain freedom (pain intensity of none) at 2 hours post-dose in efficacy analysis set were evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From after 2 hours post-dose to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants Taking Rescue Medication Within 24 Hours Post-dose | Participants who did not experience relief (pain intensity of none or mild) of their migraine headache at the end of 2 hours post-dose, or the migraine was relieved at 2 hours post-dose, but then recurred to a moderate or severe pain intensity level, were permitted to use the following rescue medications: aspirin, ibuprofen, naproxen (or any other type of nonsteroidal anti-inflammatory drug), acetaminophen up to 1000 mg/day (this included Excedrin Migraine), antiemetics (for example, metoclopramide or promethazine), or baclofen. | Efficacy analysis set was evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants With Pain Relief at 60 Minutes Post-dose | Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). | Efficacy analysis set was evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 60 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Percentage of Participants Who Returned to Normal Function at 15 Minutes Post-dose | Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 15 minutes post-dose) were reported. | The participants with functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing in efficacy analysis set were evaluated. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 15 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Zavegepant | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. After "on-treatment" participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
|
| Secondary | Number of Participants With Adverse Events (AEs) of Moderate or Severe Intensity: On-Treatment Period | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Moderate AE: A type of AE that was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activity/activities of daily living (ADL), causing discomfort, but posed no significant or permanent risk of harm to the research participant. Severe AE: A type of AE that interrupted usual ADL, or significantly affected clinical status, or might have required intensive therapeutic intervention. | Safety analysis set included participants who were enrolled and took study intervention (Zavegepant or Placebo). | Posted | | Count of Participants | | Participants | | On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days | | | | ID | Title | Description |
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| OG000 | Zavegepant: On-Treatment Period | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. | | OG001 | Placebo: On-Treatment Period |
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| Secondary | Number of Participants With AEs of Moderate or Severe Intensity: Follow-up Period | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Moderate AE: A type of AE that was usually alleviated with additional specific therapeutic intervention. The event interfered with usual ADL, causing discomfort, but posed no significant or permanent risk of harm to the research participant. Severe AE: A type of AE that interrupted usual ADL, or significantly affected clinical status, or might have required intensive therapeutic intervention. | Safety analysis set was evaluated. | Posted | | Count of Participants | | Participants | | Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days | | | | ID | Title | Description |
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| OG000 | Zavegepant: Follow-up Period | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo: Follow-up Period | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs): On-Treatment Period | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic, or other situations. | Safety analysis set was evaluated. | Posted | | Count of Participants | | Participants | | On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days | | | | ID | Title | Description |
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| OG000 | Zavegepant: On-Treatment Period | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. | | OG001 | Placebo: On-Treatment Period | |
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| Secondary | Number of Participants With SAEs: Follow-up Period | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic, or other situations. | Safety analysis set was evaluated. | Posted | | Count of Participants | | Participants | | Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days | | | | ID | Title | Description |
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| OG000 | Zavegepant: Follow-up Period | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo: Follow-up Period | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
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| Secondary | Number of Participants With Local Irritation AEs: On-Treatment Period | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local irritation AEs were associated with intranasal administration of study intervention (e.g., dysgeusia, nasal discomfort, oropharyngeal pain, throat irritation, and laryngeal discomfort). | Safety analysis set was evaluated. | Posted | | Count of Participants | | Participants | | On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days | | | | ID | Title | Description |
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| OG000 | Zavegepant: On-Treatment Period | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. | | OG001 | Placebo: On-Treatment Period | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. |
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| Secondary | Number of Participants With Local Irritation AEs: Follow-up Period | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local irritation AEs were associated with intranasal administration of study intervention (e.g., dysgeusia, nasal discomfort, oropharyngeal pain, throat irritation, and laryngeal discomfort). | Safety analysis set was evaluated. | Posted | | Count of Participants | | Participants | | Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days | | | | ID | Title | Description |
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| OG000 | Zavegepant: Follow-up Period | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. | | OG001 | Placebo: Follow-up Period | Participants who were randomized to receive a single dose of Placebo IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants were followed up for safety after the EOT visit and through the follow-up visit, up to 33 days. |
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| Secondary | Number of Participants With Grade 3 to 4 Hematological Test Abnormalities: On-Treatment Period | Hematological test abnormalities included: anemia, eosinophilia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophils count decreased, platelet count decreased and white blood cell decreased. Only those hematology test categories in which at least one participant in at least one reporting arm experienced a Grade 3 or Grade 4 abnormality were reported in this outcome measure. The hematological test abnormalities grade 3 to 4 were graded according to the common terminology criteria for adverse events (CTCAE) version (v) 5.0. | Safety analysis set was evaluated. Here, all participants reported under "Overall Number of Participants Analyzed' were evaluated but may not have evaluable data for every row and "Number Analyzed" signifies participants evaluable for the specified rows. | Posted | | Count of Participants | | Participants | | On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days | | | | ID | Title | Description |
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| OG000 | Zavegepant: On-Treatment Period | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. | | OG001 |
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| Secondary | Number of Participants With Grade 3 to 4 Clinical Chemistry Test Abnormalities: On-Treatment Period | Clinical chemistry test abnormalities included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, blood lactate dehydrogenase increased, creatine phosphokinase (CPK) increased, chronic kidney disease, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia and hyponatremia. Only those clinical chemistry test categories in which at least one participant in at least one reporting arm experienced a Grade 3 or Grade 4 abnormality were reported in this outcome measure. The clinical chemistry test abnormalities grade 3 to 4 were graded according to the CTCAE v 5.0. | Safety analysis set was evaluated. Here, all participants reported under "Overall Number of Participants Analyzed' were evaluated but may not have evaluable data for every row and "Number Analyzed" signifies participants evaluable for the specified rows. | Posted | | Count of Participants | | Participants | | On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days | | | | ID | Title | Description |
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| OG000 | Zavegepant: On-Treatment Period | Participants who were randomized to receive a single dose of Zavegepant 10 mg IN via a unidose nasal spray for the treatment of a single attack of moderate or severe headache occurring up to 45 days after the baseline/randomization visit (Day 1). Participants who took study intervention were considered "on-treatment" from the administration of study intervention and through the EOT visit, up to 10 days. |
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