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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04384367
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : May 5, 2022
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Rizatriptan 10 mg + Naproxen 550mg Drug: Maxalt 10Mg Tablet Drug: Flanax 550mg Drug: Placebo oral tablet Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1664 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 28, 2022
Estimated Primary Completion Date : January 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Rizatriptan 10mg+ Naproxen 550mg
Rizatriptan 10mg+ Naproxen 550mg
Drug: Rizatriptan 10 mg + Naproxen 550mg
oral - single dose

Active Comparator: Maxalt 10mg
Drug: Maxalt 10Mg Tablet
oral - single dose

Active Comparator: Flanax 550mg
Naproxen 550mg
Drug: Flanax 550mg
oral - single dose

Placebo Comparator: Placebo
Drug: Placebo oral tablet
oral - single dose

Primary Outcome Measures :
  1. 2-hour pain-free [ Time Frame: 11 weeks ]
    2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)

Secondary Outcome Measures :
  1. Most bothersome migraine-associated symptom [ Time Frame: 11 weeks ]
    Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04384367

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Contact: Gleyce Pinto +55 11 50908401
Contact: Cibele Boscolo +55 11 50908412

Sponsors and Collaborators
Eurofarma Laboratorios S.A.
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Responsible Party: Eurofarma Laboratorios S.A. Identifier: NCT04384367    
Other Study ID Numbers: EF167
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents