NCT01986270

Brief Summary

The objective of this study was to compare the efficacy, toleration and safety of eletriptan 40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with an acute migraine.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,141

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 1996

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1996

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1998

Completed
15.8 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

October 30, 2013

Last Update Submit

January 26, 2021

Conditions

Migraine With or Without Aura

Outcome Measures

Primary Outcomes (1)

  • Headache response at 1 hour after the first dose for 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 (1)

  • Pain-free response at 1 hour after the first dose for the first attack.

    1 hour

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 25 mg

EXPERIMENTAL
Drug: Sumatriptan 25 mg

Sumatriptan 50 mg

EXPERIMENTAL
Drug: Sumatriptan 50 mg

Interventions

PlaceboDRUG

Matching Placebo

Placebo
Eletriptan 40 mgDRUG

40mg oral

Eletriptan 40 mg
Eletriptan 80 mgDRUG

80mg oral

Eletriptan 80 mg
Sumatriptan 25 mgDRUG

25mg oral

Sumatriptan 25 mg
Sumatriptan 50 mgDRUG

50mg oral

Sumatriptan 50 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who expected to suffer at least one acute attack of migraine, with or without aura, each 6 weeks (The diagnosis of migraine was to comply with the criteria proposed by the International Headache Society (IHS))
  • Subjects capable of taking medication as outpatients, and recording the effects of such medication.

You may not qualify if:

  • Pregnant or breast-feeding women
  • Migraine subjects who also suffered from concomitant frequent (non-migrainous) headache, defined as more than six attacks per month on average.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

eletriptanSumatriptan

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsTryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic 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

October 30, 2013

First Posted

November 18, 2013

Study Start

December 1, 1996

Primary Completion

January 1, 1998

Study Completion

January 1, 1998

Last Updated

January 28, 2021

Record last verified: 2021-01