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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01989936 | Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan | PHASE3 | COMPLETED | 446 | — | — | Jan 1, 1999 | Sep 1, 2000 | Jan 27, 2021 | 43 | Denmark, Finland +3 |
| NCT01986270 | Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo | PHASE3 | COMPLETED | 1,141 | — | — | Dec 1, 1996 | Jan 1, 1998 | Jan 28, 2021 | - | — |
| NCT01986088 | Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study | PHASE3 | COMPLETED | 1,008 | — | — | Nov 1, 1996 | Jan 1, 1998 | Jan 28, 2021 | - | — |
| NCT01978496 | Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine | PHASE3 | COMPLETED | 1,334 | — | — | Jul 1, 1996 | Dec 1, 1997 | Jan 28, 2021 | - | — |
Subjects recorded the intensity of each migraine headache in the diary based on a 4-point scale: 0, pain absent; 1, mild pain; 2, moderate pain; 3, severe pain. A response was considered a change from severe or moderate pain to mild or absent at various time points after dosing with study medication
Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.
Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.
A headache response was defined as a subject having improvement in headache severity from grade 2 or 3 at baseline to 0 or 1 at two hours post-dose.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Eletriptan 40 mg | EXPERIMENTAL | - |
| Eletriptan 80 mg | EXPERIMENTAL | - |
| Sumatriptan 25 mg | EXPERIMENTAL | - |
| Sumatriptan 50 mg | EXPERIMENTAL | - |
| Sumatriptan 100 mg | EXPERIMENTAL | - |
| Eletriptan 20 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset. |
| Eletriptan 40 mg | DRUG | Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset. |
| Eletriptan 80 mg | DRUG | Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset. |
| Sumatriptan 25 mg | DRUG | 25mg oral |
| Sumatriptan 50 mg | DRUG | 50mg oral |
| Sumatriptan 100 mg | DRUG | 100mg oral |
| Eletriptan 20 mg | DRUG | 20mg oral |
Inclusion Criteria: * Male and female subjects age ≥ 18 years who met the International Headache Society (IHS) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks. * Subjects required to have discontinued ...