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

NCT01986088 | Completed Phase 3 DMC

• 1 other identifier: A160-318
• Study Type: interventional
• Target: 1,008
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine With or Without Aura

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Eletriptan 40 mg

EXPERIMENTAL

Drug: Eletriptan 40 mg

Eletriptan 80 mg

EXPERIMENTAL

Drug: Eletriptan 80 mg

Sumatriptan 50 mg

EXPERIMENTAL

Drug: Sumatriptan 50 mg

Sumatriptan 100 mg

EXPERIMENTAL

Drug: Sumatriptan 100 mg

Interventions

Placebo DRUG

matching placebo

Placebo

Eletriptan 40 mg DRUG

40mg oral

Eletriptan 40 mg

Eletriptan 80 mg DRUG

80mg oral

Eletriptan 80 mg

Sumatriptan 50 mg DRUG

50mg oral

Sumatriptan 50 mg

Sumatriptan 100 mg DRUG

100mg oral

Sumatriptan 100 mg

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

eletriptan; Sumatriptan

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: November 1, 1996
• Primary Completion: January 1, 1998
• Study Completion: January 1, 1998
• Last Updated: January 28, 2021

Record last verified: 2021-01