NCT04384367CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2068 (actual)
- First submitted
- 6 Apr 2020
- Start date
- 30 Dec 2022
- Primary completion date
- 30 Oct 2024
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Diseases
- Migraine
- NCT number
- NCT04384367
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 2068
- From 30 Dec 2022 to the primary completion date, 30 Oct 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Chronic migraine;
- Headache other than migraine (that is, tension-type headache, sinusitis, etc.).
Who the study is looking for
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CEPIC Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Eurofarma Laboratorios S.A Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.