Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo
|
Drug: Placebo
matching placebo
|
| Experimental: Eletriptan 40 mg
|
Drug: Eletriptan 40 mg
40mg oral
|
| Experimental: Eletriptan 80 mg
|
Drug: Eletriptan 80 mg
80mg oral
|
| Experimental: Sumatriptan 50 mg
|
Drug: Sumatriptan 50 mg
50mg oral
|
| Experimental: Sumatriptan 100 mg
|
Drug: Sumatriptan 100 mg
100mg oral
|
Outcome Measures
Primary Outcome Measures
- Headache response at 1 hour after treatment of the first attack. [1 hour]
Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A160-318