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

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ClinicalTrials.gov Identifier: NCT04384367

Recruitment Status : Not yet recruiting

First Posted : May 12, 2020

Last Update Posted : May 13, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Eurofarma Laboratorios S.A.

Study Description

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 (Clinical Trial)
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 Genetics related topics: Migraine

MedlinePlus related topics: Migraine

Drug Information available for: Naproxen Naproxen sodium Rizatriptan

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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 :

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

Eligibility Criteria

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

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

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