MigrainePhase 3RELIEFNCT04384367
Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine
A Phase 3 study testing Rizatriptan 10 mg + Naproxen 550mg, Maxalt 10Mg Tablet and Flanax 550mg in people with Migraine, run by Eurofarma Laboratorios S.A. at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Rizatriptan 10 mg + Naproxen 550mg, Maxalt 10Mg Tablet and Flanax 550mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,068 participants
- Where
- 2 sitesBrazil
- Study dates
- 30 Dec 2022to 30 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Chronic migraine;
- Headache other than migraine (that is, tension-type headache, sinusitis, etc.).
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Eurofarma Laboratorios S.A
São Paulo, São Paulo, 06696-000
CEPIC
São Paulo, São Paulo
About this study
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
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).
Read the 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).
- Conditions
- Migraine
- Being tested
- Rizatriptan 10 mg + Naproxen 550mg, Maxalt 10Mg Tablet, Flanax 550mg, Placebo oral tablet
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rizatriptan 10 mg + Naproxen 550mgDrug
Also called Medicamento
oral - single dose
Maxalt 10Mg TabletDrug
Also called Medicamento
oral - single dose
Flanax 550mgDrug
Also called Medicamento
oral - single dose
Placebo oral tabletDrug
Also called Medicamento
oral - single dose
| Study group | Role | What they receive |
|---|---|---|
| Rizatriptan 10mg+ Naproxen 550mg | Experimental | Rizatriptan 10mg+ Naproxen 550mg Receives: Drug: Rizatriptan 10 mg + Naproxen 550mg |
| Maxalt 10mg | Active comparator | Rizatriptan10mg Receives: Drug: Maxalt 10Mg Tablet |
| Flanax 550mg | Active comparator | Naproxen 550mg Receives: Drug: Flanax 550mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-hour pain-free
2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)
Measured: 11 weeks
Secondary outcomes (1)
Most bothersome migraine-associated symptom
Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start30 Dec 2022
- Primary completion30 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,068 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384367
- Sponsor's protocol ID
- EF167
- Acronym
- RELIEF
- Status last verified
- Oct 2026
- First submitted
- 6 Apr 2020
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04384367
- Acronym / sponsor ID
- RELIEF / EF167
- Conditions
- Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,068 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rizatriptan 10mg+ Naproxen 550mg | Experimental | Drug: Rizatriptan 10 mg + Naproxen 550mgRizatriptan 10mg+ Naproxen 550mg |
| Maxalt 10mg | Active comparator | Drug: Maxalt 10Mg TabletRizatriptan10mg |
| Flanax 550mg | Active comparator | Drug: Flanax 550mgNaproxen 550mg |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Chronic migraine;
- Headache other than migraine (that is, tension-type headache, sinusitis, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rizatriptan 10 mg + Naproxen 550mgAlso: Medicamentooral - single dose | Drug | Rizatriptan 10mg+ Naproxen 550mg |
| Maxalt 10Mg TabletAlso: Medicamentooral - single dose | Drug | Maxalt 10mg |
| Flanax 550mgAlso: Medicamentooral - single dose | Drug | Flanax 550mg |
| Placebo oral tabletAlso: Medicamentooral - single dose | Drug | Placebo |
Primary outcome
2-hour pain-free
Time frame: 11 weeks
2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)
1 secondary outcome
Most bothersome migraine-associated symptom
Time frame: 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rizatriptan 10 mg + Naproxen 550mg, Maxalt 10Mg Tablet and Flanax 550mg in people with Migraine, run by Eurofarma Laboratorios S.A. at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-hour pain-free (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.