| 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 diary (eDiary). Pain freedom was defined as pain level of none. | The analysis was performed on modified intent to treat (mITT) participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00021.2(18.1 to 24.3)
- OG00110.9(8.5 to 13.2)
|
|
| | 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 | | Risk Difference (RD) | 10.4 | | | 2-Sided | 95 | 6.5 | 14.2 | | | | | Superiority | | |
|
| Primary | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| 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 eDiary. Pain relief was defined as pain level of none or mild. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose | Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From 2 hours up to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose | MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From 2 hours up to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| 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 eDiary) 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 (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the participant in a paper diary. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose | Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From 2 hours up to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From 2 hours up to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose | MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From 2 hours up to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose | Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From 2 hours up to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| 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 eDiary. Freedom from photophobia was defined as photophobia absent. | The analysis was performed on mITT participants with photophobia present at migraine onset. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose | Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 90 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Pain Relief at 90 Minutes Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 90 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From 2 hours up to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose | MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 90 minutes post dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 90 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| 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 eDiary. Freedom from phonophobia was defined as phonophobia absent. | The analysis was performed on mITT participants with phonophobia present at migraine onset. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From 2 hours up to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| 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 eDiary. Pain relief was defined as pain level of none or mild. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 60 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose | Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function. | The analysis was performed on mITT participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 60 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| Secondary | Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose | Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent. | The analysis was performed on mITT participants with nausea present at migraine onset. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |
| 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 eDiary. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose for the participants who were pain-free at 2 hours post-dose. | The analysis population was performed on mITT participants with pain freedom at 2 hours post-dose. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From 2 hours up to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rimegepant 75 mg ODT | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. | | OG001 | Placebo | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| |