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

Eurofarma

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Maxalt 10Mg Tablet; Drug: Placebo oral tablet; Drug: Rizatriptan 10 mg + Naproxen 550mg; Drug: Flanax 550mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04384367

EF167

Details and patient eligibility

About

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).

Full 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).

Enrollment: 2,068 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

2,068 participants in 4 patient groups, including a placebo group

Rizatriptan 10mg+ Naproxen 550mg

Experimental group

Description:

Rizatriptan 10mg+ Naproxen 550mg

Treatment:

Drug: Rizatriptan 10 mg + Naproxen 550mg

Maxalt 10mg

Active Comparator group

Description:

Rizatriptan10mg

Treatment:

Drug: Maxalt 10Mg Tablet

Flanax 550mg

Active Comparator group

Description:

Naproxen 550mg

Treatment:

Drug: Flanax 550mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo oral tablet