| Primary | Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment | Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe. | Full Analysis Set (FAS): all participants in the Safety Population (all participants who took >=1 dose of investigational product [IP]) who provided any post-treatment efficacy assessment. Analysis was performed on the last observation carried forward (LOCF) dataset (imputed by LOCF method). Only post-treatment values were used for imputation. | Posted | | Number | | percentage of participants | | 120 minutes post-treatment (Randomization through Final Visit [Week 6]) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe. | | OG001 | Sumatriptan Pooled | All participants receiving either sumatriptan 25 mg or 50 mg |
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| | 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 |
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| | Chi-squared | | 0.345 | Multiplicity was not considered because the primary analysis included a single statistical comparison. | Percent Difference | -7.49 | | | 2-Sided | 95 | -23.02 | 8.04 | | | Percent difference = sumatriptan pooled group minus the placebo group | | Superiority or Other | | |
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| Secondary | Percentage of Participants Who Reported Pain Relief at 30, 60, 120, and 240 Minutes Post-Treatment | Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe. | FAS. The analysis was performed on the LOCF dataset. | Posted | | Number | | percentage of participants | | 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6]) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe. | | OG001 | Sumatriptan 25 mg | Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale. |
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| Secondary | Percentage of Participants Who Were Pain Free at 30, 60, 120, and 240 Minutes Post-Treatment | Pain free was defined as a post-treatment pain intensity score of 1 on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took a rescue medication. The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 =mild, 3=mild to moderate, 4=moderate to severe, and 5=severe. | FAS. The analysis was performed on the LOCF dataset. | Posted | | Number | | percentage of participants | | 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6]) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe. | | OG001 | Sumatriptan 25 mg | Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale. | |
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| Secondary | Percentage of Participants Who Were Photophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment | Photophobia (sensitivity to light) is one of the associated symptoms of a migraine. A participant was assessed as photophobia free when the symptom was recorded as "absent" at each time point in his or her patient diary. Photophobia was recorded as "present" for all subsequent assessments if a participant took rescue medication. | FAS. The analysis was performed on the LOCF dataset. Only participants who had photophobia at the time of treatment were included in the denominator. | Posted | | Number | | percentage of participants | | 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6]) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe. | | OG001 | Sumatriptan 25 mg | Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale. | | OG002 |
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| Secondary | Percentage of Participants Who Were Phonophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment | Phonophobia (sensitivity to sound) is one of the associated symptoms of a migraine. A participant was assessed as phonophobia free when the symptom was recorded as "absent" at each time point in his or her patient diary. Phonophobia was recorded as "present" for all subsequent assessments if a participant took rescue medication. | FAS. The analysis was performed on the LOCF dataset. Only participants who had phonophobia at the time of treatment were included in the denominator. | Posted | | Number | | percentage of participants | | 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6]) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe. | | OG001 | Sumatriptan 25 mg | Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale. | | OG002 |
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| Secondary | Percentage of Participants Who Were Nausea Free at 30, 60, 120, and 240 Minutes Post-Treatment | Nausea is one of the associated symptoms of a migraine. A participant was assessed as nausea free when the symptom was recorded as "absent" at each time point in his or her patient diary. Nausea was recorded as "present" for all subsequent assessments if a participant took rescue medication. | FAS. The analysis was performed on the LOCF dataset. Only participants who had nausea at the time of treatment were included in the denominator. | Posted | | Number | | percentage of participants | | 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6]) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe. | | OG001 | Sumatriptan 25 mg | Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale. | | OG002 | Sumatriptan 50 mg |
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| Secondary | Percentage of Participants Who Were Free of Vomiting at 30, 60, 120, and 240 Minutes Post-Treatment | Vomiting is one of the associated symptoms of a migraine. A participant was assessed as being free of vomiting when the symptom was recorded as "absent" at each time point in his or her patient diary. Vomiting was recorded as "present" for all subsequent assessments if a participant took a rescue medication. | FAS. The analysis was performed on the LOCF dataset. Only participants who had vomiting at the time of treatment were included in the denominator. | Posted | | Number | | percentage of participants | | 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6]) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe. | | OG001 | Sumatriptan 25 mg | Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale. | | OG002 |
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| Secondary | Percentage of Participants Who Used Rescue Medication Between the Time of Dosing and 240 Minutes Post-Treatment | Rescue medication included one of the following: a single oral dose of a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, not to exceed the maximum recommended single dose; and anti-emetics (a drug to prevent vomiting). | FAS. The analysis was performed on the observed case dataset, a dataset without any imputation of missing data. | Posted | | Number | | percentage of participants | | within 240 minutes post-treatment (Randomization through Final Visit [Week 6]) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe. | | OG001 | Sumatriptan 25 mg | Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale. | | OG002 | Sumatriptan 50 mg | |
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