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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01986088
Other study ID # A160-318
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 1996
Est. completion date January 1998

Study information

Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1008
Est. completion date January 1998
Est. primary completion date January 1998
Accepts healthy volunteers No
Gender All
Age group 18 Years to 76 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
matching placebo
Eletriptan 40 mg
40mg oral
Eletriptan 80 mg
80mg oral
Sumatriptan 50 mg
50mg oral
Sumatriptan 100 mg
100mg oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Headache severity .5, 1, 2, 4 and 24 hours
Secondary Pain-free response .5, 1, 2, 4 and 24 hours
Secondary Functional response .5, 1, 2, 4 and 24 hours
Secondary Presence or absence of nausea, photophobia, and phonophobia .5, 1, 2, 4 and 24 hours
See also
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Completed NCT00382993 - A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2) Phase 3
Completed NCT01986270 - Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo Phase 3
Completed NCT03194555 - The Preventive Treatment of Migraine With Low-Dose Naltrexone and Acetaminophen Combination Phase 2