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

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

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).

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Rizatriptan 10 mg + Naproxen 550mg; Drug: Maxalt 10Mg Tablet; Drug: Flanax 550mg; Drug: Placebo oral tablet

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 Type: Interventional
• Enrollment (Actual): 2068
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 06696-000
    • Eurofarma Laboratórios S.A
  • SP
    • São Paulo, SP, Brazil
      • CEPIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo oral tablet; oral - single dose; Other Names: Medicamento
Experimental: Rizatriptan 10mg+ Naproxen 550mg	Drug: Rizatriptan 10 mg + Naproxen 550mg; oral - single dose; Other Names: Medicamento
Active Comparator: Maxalt 10mg; Rizatriptan10mg	Drug: Maxalt 10Mg Tablet; oral - single dose; Other Names: Medicamento
Active Comparator: Flanax 550mg; Naproxen 550mg	Drug: Flanax 550mg; oral - single dose; Other Names: Medicamento

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-hour pain-free	2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)	11 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Most bothersome migraine-associated symptom	Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)	11 weeks

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2022
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Gout Suppressants; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Serotonin Agents; Serotonin Receptor Agonists; Naproxen; Rizatriptan
• Other Study ID Numbers: EF167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No