Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentre, Double Blind, Double Dummy, Parallel Group, Placebo Controlled, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels Oral Sumatriptan Given for the Acute Treatment of Migraine(With and Without Aura).

Conditions
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Migraine With or Without Aura

Intervention / Treatment
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* Drug: Placebo
* Drug: Eletriptan 40 mg
* Drug: Eletriptan 80 mg
* Drug: Sumatriptan 50 mg
* Drug: Sumatriptan 100 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible patients were men and women with a minimum age limit of 18 years of age (in Canada there was also an age limit of 65 years) who were expected to have at least one attack of migraine with or without aura, as defined by the International Headache Society (IHS) criteria,15 every 6 weeks. Patients had to be capable of taking study medication as outpatients and recording the effects. Exclusion Criteria: Pregnant or breast-feeding women and those not using adequate contraception were excluded from the trial. Patients with frequent nonmigrainous headache, atypical migraine that had not previously responded to therapy, migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction were excluded from the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* matching placebo<br>|
| Experimental: Eletriptan 40 mg<br> | Drug: Eletriptan 40 mg<br>* 40mg oral<br>|
| Experimental: Eletriptan 80 mg<br> | Drug: Eletriptan 80 mg<br>* 80mg oral<br>|
| Experimental: Sumatriptan 50 mg<br> | Drug: Sumatriptan 50 mg<br>* 50mg oral<br>|
| Experimental: Sumatriptan 100 mg<br> | Drug: Sumatriptan 100 mg<br>* 100mg oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | .5, 1, 2, 4 and 24 hours | 
| Presence or absence of nausea, photophobia, and phonophobia |  | .5, 1, 2, 4 and 24 hours |