Status:
COMPLETED
Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 treat...
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...
Eligibility Criteria
Inclusion
- 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
- Chronic migraine;
- Headache other than migraine (that is, tension-type headache, sinusitis, etc.).
Key Trial Info
Start Date :
December 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
2068 Patients enrolled
Trial Details
Trial ID
NCT04384367
Start Date
December 30 2022
End Date
November 30 2024
Last Update
February 14 2025
Active Locations (2)
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1
Eurofarma Laboratorios S.A
São Paulo, São Paulo, Brazil, 06696-000
2
CEPIC
São Paulo, São Paulo, Brazil