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

February 16, 2024 updated by: Eurofarma Laboratorios S.A.

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

1664

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 11 weeks
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
Time Frame: 11 weeks
Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurofarma Laboratorios S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2022

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

January 30, 2025

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)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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