Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00898677 | Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030) | PHASE3 | COMPLETED | 1,268 | — | — | Sep 1, 1995 | Sep 1, 1996 | Feb 3, 2022 | - | — |
| NCT00897104 | MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029) | PHASE3 | COMPLETED | 933 | — | — | Aug 1, 1995 | Sep 1, 1996 | Feb 3, 2022 | - | — |
| NCT00899379 | Treatment of Multiple Attacks of Acute Migraine (0462-025) | PHASE3 | COMPLETED | 473 | — | — | Apr 1, 1995 | Apr 1, 1996 | Feb 3, 2022 | - | — |
| NCT00897949 | MK0462 in Treatment of Migraine With Recurrence (MK0462-022) | PHASE3 | COMPLETED | 1,473 | — | — | Mar 1, 1995 | Jul 1, 1996 | Feb 3, 2022 | - | — |
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose
Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack
Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | rizatriptan 5 mg |
| 2 | EXPERIMENTAL | rizatriptan 10 mg |
| 3 | ACTIVE_COMPARATOR | sumatriptan 100 mg |
| 4 | PLACEBO_COMPARATOR | placebo |
| Treatment Sequence 1 | EXPERIMENTAL | Placebo-Rizatriptan-Rizatriptan-Rizatriptan |
| Treatment Sequence 2 | EXPERIMENTAL | Rizatriptan-Placebo-Rizatriptan-Rizatriptan |
| Treatment Sequence 3 | EXPERIMENTAL | Rizatriptan-Rizatriptan-Placebo-Rizatriptan |
| Treatment Sequence 4 | EXPERIMENTAL | Rizatriptan-Rizatriptan-Rizatriptan-Placebo |
| Treatment Sequence 5 | EXPERIMENTAL | Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan |
| Rizatriptan 10 mg | EXPERIMENTAL | - |
| Rizatriptan 5 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| rizatriptan benzoate | DRUG | single dose administration of 5mg rizatriptan (by Mouth) p.o. |
| Comparator: sumatriptan | DRUG | single dose administration of sumatriptan 100 p.o. |
| Comparator: Placebo | DRUG | placebo to rizatriptan |
| rizatriptan benzoate (MK0462) | DRUG | single dose 5 mg rizatriptan p.o. |
Inclusion Criteria: * Patient had at least a 6-month history of migraine, with or without aura * Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions. * Patient was judged to be in good health, apart from migraine Exclusi...