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Can a Two-Drug migraine pill stop pain in two hours?

NCT ID NCT04384367

Symptom relief Sponsor: Eurofarma Laboratorios S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 22, 2026 · Last updated Sep 23, 2026 · Updated 1 time

Summary

Researchers are testing a single oral tablet that combines rizatriptan and naproxen to treat acute migraine attacks. The trial enrolls adults aged 18 to 65 in Brazil who have migraine with or without aura. Participants receive one dose of the combination or a placebo, and researchers measure how many are pain-free at two hours and whether nausea, vomiting, and sensitivity to light or sound improve.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A single oral tablet combining rizatriptan 10 mg and naproxen 550 mg
What this could lead to
If it works, this combination could offer a fast, single-dose option to stop migraine pain and related symptoms like nausea and light sensitivity.
What could go wrong
This is a phase 3 trial, so the combination may not beat placebo or may cause side effects. Results from Brazil may not apply to everyone, and it is not for chronic migraine or other headache types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,068 people

The number who actually took part.

Started

Dec 2022

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients of both sexes; * Aged between 18 and 65 years old; * Capable and willing to give free and informed informed consent in writing; * Migraine patients with or without aura, according to the International Headache Society (IHS). Exclusion Criteria: * Chronic migraine; * Headache other than migraine (that is, tension-type headache, sinusitis, etc.).

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

Contacts and locations

Locations

  • CEPIC

    São Paulo, São Paulo, Brazil

  • Eurofarma Laboratorios S.A

    São Paulo, São Paulo, 06696-000, Brazil

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