NCT04384367

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,068 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

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

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Rizatriptan 10 mg + Naproxen 550mg	oral - single dose
DRUG	Maxalt 10Mg Tablet	oral - single dose
DRUG	Flanax 550mg	oral - single dose
DRUG	Placebo oral tablet	oral - single dose

Timeline

• Start date: 2022-12-30
• Primary completion: 2024-10-30
• Completion: 2024-11-30
• First posted: 2020-05-12
• Last updated: 2025-02-14

Locations

2 sites across 1 country: Brazil