NCT01978496

Brief Summary

To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,334

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 1996

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

July 1, 1996

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1997

Completed
15.9 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

October 31, 2013

Last Update Submit

January 26, 2021

Conditions

Migraine With or Without Aura

Outcome Measures

Primary Outcomes (1)

  • Headache responder rate at two hours after the first dose for the first attack.

    A headache response was defined as a subject having improvement in headache severity from grade 2 or 3 at baseline to 0 or 1 at two hours post-dose.

    2 hours

Secondary Outcomes (1)

  • Pain free responder rate at two hours after the first dose for the first attack.

    2 hours

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Eletriptan 20 mg

EXPERIMENTAL
Drug: Eletriptan 20 mg

Eletriptan 40 mg

EXPERIMENTAL
Drug: Eletriptan 40 mg

Eletriptan 80 mg

EXPERIMENTAL
Drug: Eletriptan 80 mg

Interventions

PlaceboDRUG

matching placebo

Placebo
Eletriptan 20 mgDRUG

20mg oral

Eletriptan 20 mg
Eletriptan 40 mgDRUG

40mg oral

Eletriptan 40 mg
Eletriptan 80 mgDRUG

80mg oral

Eletriptan 80 mg

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria.
  • Capable of taking study medication as outpatients and recording its effects.

You may not qualify if:

  • Pregnant or breast-feeding women
  • Migraine subjects who also suffered from concomitant frequent (non-migraine) headache, defined as more than six headaches per month on average
  • Migraine attacks that were thought to be atypical and had consistently failed to respond to medical therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

eletriptan

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 31, 2013

First Posted

November 7, 2013

Study Start

July 1, 1996

Primary Completion

December 1, 1997

Study Completion

December 1, 1997

Last Updated

January 28, 2021

Record last verified: 2021-01