Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo

A Multicenter, Double-blind, Placebo Controlled, Parallel Group, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels of of Oral Sumatriptan Given for the Acute Treatment of Migraine

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01986270

Enrollment

1141

Registered

2013-11-18

Start date

1996-12-31

Completion date

1998-01-31

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine With or Without Aura

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.

Interventions

DRUGPlacebo

Matching Placebo

DRUGEletriptan 40 mg

40mg oral

DRUGEletriptan 80 mg

80mg oral

DRUGSumatriptan 25 mg

25mg oral

DRUGSumatriptan 50 mg

50mg oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Headache response at 1 hour after the first dose for the first attack.	1 hour	Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.

Secondary

Measure	Time frame	Description
Pain-free response at 1 hour after the first dose for the first attack.	1 hour	A pain free response was defined as an improvement from a severe or moderate headache at baseline to an absent headache post-dose.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026