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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.
 
ClinicalTrials.gov Identifier: NCT04384367
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

Study Description
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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.
Study Design
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Study Type : Interventional
Estimated Enrollment : 1524 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 : February 28, 2021
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arms and Interventions
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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
Rizatriptan10mg
 Drug: Maxalt 10Mg Tablet
oral - single dose
Active Comparator: Flanax 550mg
Naproxen 550mg
 Drug: Flanax 550mg
oral - single dose
Placebo Comparator: Placebo
Placebo
 Drug: Placebo oral tablet
oral - single dose


Outcome Measures
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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)


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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.).
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04384367


Contacts
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Contact: Laura Caram +55 11 50908217 laura.caram@eurofarma.com.br
Contact: Cassiano Berto +55 11 50908412 cassiano.berto@eurofarma.com.br

Sponsors and Collaborators
Eurofarma Laboratorios S.A.
More Information
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Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT04384367    
Other Study ID Numbers: EF167
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
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
Naproxen
Rizatriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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