| Primary | Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose | Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose. | The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose. | Posted | | Number | | Participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Telcagepant 150 mg | Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. | | OG001 | Telcagepant 300 mg | Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. | | OG002 | Zolmitriptan 5 mg | Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication. | | OG003 | Placebo | Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication. |
| | Units | Counts |
|---|
| Participants | - OG000317
- OG001338
- OG002328
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00056
- OG00189
- OG002101
- OG003
|
|
| | 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 |
|---|
| | Regression, Logistic | | <0.001 | | Odds Ratio (OR) | 2.26 | | | 2-Sided | 95 | 1.40 | 3.66 | | | From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison. | | Superiority or Other | | | | |
|
| Primary | Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose | Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PR at 2 hours post-dose is defined as a shift from a moderate or severe migraine headache (Grade 2 or 3) at baseline to mild or no pain (Grade 1 or 0) at 2 hours post-dose. | The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose. | Posted | | Number | | Participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Telcagepant 150 mg | Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. | | OG001 | Telcagepant 300 mg | Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. |
|
| Primary | Number of Participants With Absence of Photophobia at 2 Hours Post-Dose | Participants were asked if they experienced any sensitivity to light. The number of participants who experienced no photophobia (sensitivity to light) at 2 hours post-dose was determined. | The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline photophobia assessment, and had at least one photophobia assessment within 2 hours post-dose. | Posted | | Number | | Participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Telcagepant 150 mg | Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. | | OG001 | Telcagepant 300 mg | Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. | |
|
| Primary | Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose | Participants were asked if they experienced any sensitivity to sound. The number of participants who experienced no phonophobia (sensitivity to sound) at 2 hours post-dose was determined. | The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline phonophobia assessment, and had at least one phonophobia assessment within 2 hours post-dose. | Posted | | Number | | Participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Telcagepant 150 mg | Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. | | OG001 | Telcagepant 300 mg | Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. | |
|
| Primary | Number of Participants With Absence of Nausea at 2 Hours Post-Dose | Participants were asked if they experienced any nausea. The number of participants who experienced no nausea at 2 hours post-dose was determined. | The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline nausea assessment, and had at least one nausea assessment within 2 hours post-dose. | Posted | | Number | | Participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Telcagepant 150 mg | Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. | | OG001 | Telcagepant 300 mg | Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. | | OG002 |
|
| Secondary | Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose | SPF is defined as PF at 2 hours post-dose with no return of mild/moderate/severe headache through 24 hours post-dose, and with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose. | The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one pain score measurement at between 2 and 24 hours post-dose. | Posted | | Number | | Participants | | 2 to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Telcagepant 150 mg | Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. | | OG001 | Telcagepant 300 mg | Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. |
|
| Secondary | Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose | TMF at 2 hours post-dose is defined as PF at 2 hours post-dose without any of the following migraine-related symptoms: phonophobia, photophobia, nausea or vomiting at 2 hours post-dose. | The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 hours post-dose. | Posted | | Number | | Participants | | 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Telcagepant 150 mg | Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. | | OG001 | Telcagepant 300 mg | Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. |
|
| Secondary | Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose | TMF at 2 to 24 hours post-dose is defined as TMF at 2 hours post-dose with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose, no return of mild/moderate/severe headache within 24 hours and no presence of phonophobia, photophobia, nausea or vomiting within 24 hours post-dose. | The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 to 24 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 to 24 hours post-dose. | Posted | | Number | | Participants | | 2 to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Telcagepant 150 mg | Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. | | OG001 | Telcagepant 300 mg | Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. |
|
| Primary | Number of Participants Who Experience At Least One Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 14 days after last dose study drug. Participants who took both active and placebo study drug were counted in the active group. | The population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE. | Posted | | Number | | Participants | | Up to 14 days after last dose of study drug | | | | ID | Title | Description |
|---|
| OG000 | Telcagepant 150 mg | Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. | | OG001 | Telcagepant 300 mg | Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. |
|
| Primary | Number of Participants Who Discontinue Study Drug Due to an AE | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants who took both active and placebo study drug were counted in the active group. | The populaton consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE. | Posted | | Number | | Participants | | Up to 48 hours after first dose of study drug | | | | ID | Title | Description |
|---|
| OG000 | Telcagepant 150 mg | Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. | | OG001 | Telcagepant 300 mg | Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. |
|