Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine
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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 5, 2022
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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 |
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 |

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 |
- 2-hour pain-free [ Time Frame: 11 weeks ]2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)
- Most bothersome migraine-associated symptom [ Time Frame: 11 weeks ]Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)

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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.).

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
Contact: Gleyce Pinto | +55 11 50908401 | Gleyce.lima@eurofarma.com | |
Contact: Cibele Boscolo | +55 11 50908412 | cibele.boscolo@eurofarma.com |
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 5, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
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 |