Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine

NCT ID: NCT01978496

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1334 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-07-31

Study Completion Date

1997-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine With or Without Aura

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo

Eletriptan 20 mg

Group Type EXPERIMENTAL

Eletriptan 20 mg

Intervention Type DRUG

20mg oral

Eletriptan 40 mg

Group Type EXPERIMENTAL

Eletriptan 40 mg

Intervention Type DRUG

40mg oral

Eletriptan 80 mg

Group Type EXPERIMENTAL

Eletriptan 80 mg

Intervention Type DRUG

80mg oral

Interventions

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Placebo

matching placebo

Intervention Type DRUG

Eletriptan 20 mg

20mg oral

Intervention Type DRUG

Eletriptan 40 mg

40mg oral

Intervention Type DRUG

Eletriptan 80 mg

80mg oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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A160-102

Identifier Type: -

Identifier Source: org_study_id

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