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Label indication RELPAX is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: • Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with RELPAX, reconsider the diagnosis of migraine before RELPAX is administered to treat any subsequent attacks. • RELPAX is not intended for the prevention of migraine attacks. FDA label
Eletriptan · 4 trials · 1 indication
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 ...