Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 ...
Eletriptan is used for the acute treatment of migraine with or without aura in adults. It is an investigational small molecule being developed by Pfizer, Inc. for the Neurology therapeutic area. The drug is administered orally and has been studied in Phase 3 clinical trials for this indication.
Eletriptan is a small molecule that targets serotonin receptors, specifically acting as a selective agonist at 5-HT1B and 5-HT1D receptors. This mechanism is believed to constrict cranial blood vessels and inhibit pro-inflammatory neuropeptide release, which helps relieve migraine symptoms.
Eletriptan is being developed by Pfizer, Inc., a pharmaceutical company publicly traded under the ticker symbol PFE. Pfizer has conducted multiple Phase 3 clinical trials evaluating the drug for the treatment of migraine with or without aura.
Eletriptan is in Phase 3 clinical development. It has completed four Phase 3 trials, all of which are finished, with no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities based on the available data.
Eletriptan has completed four Phase 3 clinical trials: NCT01978496, NCT01986088, NCT01986270, and NCT01989936. These trials enrolled a total of 3,929 participants and evaluated the drug's efficacy, safety, and tolerability for acute migraine treatment, including comparisons with sumatriptan and placebo.
No, Eletriptan is not the same as sumatriptan. They are different medications, though both belong to the triptan class used for migraine. Clinical trials have directly compared Eletriptan with sumatriptan, including studies NCT01986088 and NCT01986270, to evaluate their relative efficacy and safety.