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

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: Rizatriptan 10 mg + Naproxen 550mg; Drug: Maxalt 10Mg Tablet; Drug: Flanax 550mg; Drug: Placebo oral tablet

• Registration Number: NCT04384367
• Lead Sponsor: Eurofarma Laboratorios S.A.

Brief 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).

Study Timeline

• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Study Start: 2022-12-30
• Primary Completion: 2024-10-30
• Study Completion: 2024-11-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2068

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rizatriptan 10mg+ Naproxen 550mg	Rizatriptan 10 mg + Naproxen 550mg	Rizatriptan 10mg+ Naproxen 550mg
Maxalt 10mg	Maxalt 10Mg Tablet	Rizatriptan10mg
Flanax 550mg	Flanax 550mg	Naproxen 550mg
Placebo	Placebo oral tablet	Placebo

Primary Outcome Measures

Name	Time	Method
2-hour pain-free	11 weeks	2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)

Secondary Outcome Measures

Name	Time	Method
Most bothersome migraine-associated symptom	11 weeks	Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)

Trial Locations

Locations (2)

CEPIC; 🇧🇷 São Paulo, SP, Brazil

Eurofarma Laboratorios S.A; 🇧🇷 São Paulo, Brazil