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Completed

NCT Number: NCT04384367

Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine

A phase III study, multicenter, double-blind, double-dummy, randomized, single-dose, placebo-controlled study to evaluate the efficacy and safety of Rizatriptan-Naproxen (10/550 mg) in the acute treatment of migraine.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEPIC, São Paulo, Brazil

Loading trial locations.

About this study

This is a prospective, randomized, double-blind, double-dummy and placebo-controlled study in individuals with disabling migraine. The participants will be randomized to receive Rizatriptan + Naproxen (10/550mg), Rizatriptan (10mg), Naproxen (550mg) or placebo.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Rizatriptan 10 mg + Naproxen 550mg

Drug

oral - single dose

Other names: Medicamento

Maxalt 10Mg Tablet

Drug

oral - single dose

Other names: Medicamento

Flanax 550mg

Drug

oral - single dose

Other names: Medicamento

Placebo oral tablet

Drug

oral - single dose

Other names: Medicamento

Primary outcomes

  1. 2-hour pain-free

    Time frame: 11 weeks

    2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)

Secondary outcomes

  1. Most bothersome migraine-associated symptom

    Time frame: 11 weeks

    Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)

Sponsors and collaborators

Lead sponsor

Eurofarma Laboratorios S.A.

Industry

Registry information

Official study title

A Multicenter, Double-blind, Double-dummy, Randomized, Single-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine

Acronym: RELIEF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 12, 2020
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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