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

Phase

Condition

Chronic Pain

Oral Facial Pain

Headaches

Treatment

Flanax 550mg

Placebo oral tablet

Rizatriptan 10 mg + Naproxen 550mg

Clinical Study ID

NCT04384367

EF167

Ages 18-65
All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 HeadacheSociety (IHS).

Exclusion

Exclusion Criteria:

Chronic migraine;
Headache other than migraine (that is, tension-type headache, sinusitis, etc.).

Study Design

Flanax 550mg

December 30, 2022

November 30, 2024

Study Description

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.