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A previously published, placebo-controlled, head-to-head comparator study found eletriptan to have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack. The goal of the current study was to extend the findings of that study by examining the efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to evaluate the comparative efficacy of eletriptan and sumatriptan across additional important clinical outcomes. In particular, early response (at 1 hour), sustained response (without need for additional treatment) at 24 hours, and consistency of response across multiple attacks were examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Eletriptan 40 mg | Experimental |
| |
| Eletriptan 80 mg | Experimental |
| |
| Sumatriptan 50 mg | Experimental |
| |
| Sumatriptan 100 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | matching placebo |
| |
| Eletriptan 40 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Headache response at 1 hour after treatment of the first attack. | Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Headache severity | .5, 1, 2, 4 and 24 hours | |
| Pain-free response | .5, 1, 2, 4 and 24 hours | |
| Functional response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C115647 | eletriptan |
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Drug |
40mg oral |
|
| Eletriptan 80 mg | Drug | 80mg oral |
|
| Sumatriptan 50 mg | Drug | 50mg oral |
|
| Sumatriptan 100 mg | Drug | 100mg oral |
|
| .5, 1, 2, 4 and 24 hours |
| Presence or absence of nausea, photophobia, and phonophobia | .5, 1, 2, 4 and 24 hours |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |