> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-rizatriptan-naproxen-10-550-mg-in-the-70efddef-4813-48a4-864f-4182d7fde312 > Record changed: 2026-10-13 # Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine NCT04384367 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) Participants 2,068 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) Lead sponsor Eurofarma Laboratorios S.A. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) Start date 2022-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) ## Title and summary **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. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Acronym** RELIEF Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Short title** Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) ## Dates **Completion date** 2024-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **First posted** 2020-05-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Registry last updated** 2025-02-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Primary completion date** 2024-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Start date** 2022-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) ## Size and sites **Actual participants** 2,068 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Participants** 2,068 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Lead sponsor** Eurofarma Laboratorios S.A. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) ## Identifiers **Registry ID** NCT04384367 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **ClinicalTrials.gov ID** NCT04384367 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) ## Outcomes ### Primary outcomes 1. 2-hour pain-free Timeframe: 11 weeks 2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose) ### Secondary outcomes 1. Most bothersome migraine-associated symptom Timeframe: 11 weeks Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **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.). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) ## Sites - Eurofarma Laboratorios S.ASão Paulo, Brazil - CEPICSão Paulo, Brazil Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384367) ## Related records ### Drugs (2) - [Naproxen](https://trialight.com/data/asset/naproxen-f8832358-74f9-4a7d-ac13-bc9bb9f4661b.md) - [Rizatriptan](https://trialight.com/data/asset/rizatriptan-62bc4777-817b-40f6-b936-bbc1eba350d2.md) ### Lead sponsors (1) - [Eurofarma Laboratorios S.A.](https://trialight.com/data/company/eurofarma-laboratorios-s-a-520d9fcc-90dc-4a51-b915-1e6439ae2fb1.md) ### Conditions (1) - [Migraine disorder](https://trialight.com/data/condition/migraine-disorder-0a28e77d-6415-5582-980f-2d0721f95f76.md) Primary condition ### Targets (4) - [HTR1B](https://trialight.com/data/target/htr1b-f109dd33-597e-57af-8498-727af113b42b.md) - [HTR1D](https://trialight.com/data/target/htr1d-8c6c6eaa-650d-574b-b5ed-aa796d90ad80.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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