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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04384367
Acronym
RELIEF
Enrollment
2068
Registered
2020-05-12
Start date
2022-12-30
Completion date
2024-11-30
Last updated
2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

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. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

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 will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Interventions

DRUGRizatriptan 10 mg + Naproxen 550mg

oral - single dose

DRUGMaxalt 10Mg Tablet

oral - single dose

DRUGFlanax 550mg

oral - single dose

DRUGPlacebo oral tablet

oral - single dose

Sponsors

Eurofarma Laboratorios S.A.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 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.).

Design outcomes

Primary

MeasureTime frameDescription
2-hour pain-free11 weeks2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)

Secondary

MeasureTime frameDescription
Most bothersome migraine-associated symptom11 weeksMigraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026