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

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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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

Conditions
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Migraine

Intervention / Treatment
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* Drug: Rizatriptan 10 mg + Naproxen 550mg
* Drug: Maxalt 10Mg Tablet
* Drug: Flanax 550mg
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |