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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04384367
• Other study ID #: EF167
• Status: Recruiting
• Phase: Phase 3
• Start date: December 30, 2022
• Est. completion date: January 30, 2025

Study information

• Verified date: May 2024
• Source: Eurofarma Laboratorios S.A.
• Contact: Gleyce Lima, Analyst
• Phone: 55 11 5090 8411
• Email: gleyce.lima[@]eurofarma.com
• Is FDA regulated: No
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2068
• Est. completion date: January 30, 2025
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Rizatriptan 10 mg + Naproxen 550mg
oral - single dose
• Maxalt 10Mg Tablet
oral - single dose
• Flanax 550mg
oral - single dose
• Placebo oral tablet
oral - single dose

Locations

Country	Name	City	State
Brazil	CEPIC	São Paulo	SP
Brazil	Eurofarma Laboratorios S.A	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-hour pain-free	2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)	11 weeks
Secondary	Most bothersome migraine-associated symptom	Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)	11 weeks