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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,068
Eurofarma Laboratorios S.A
São Paulo, São Paulo, Brazil
CEPIC
São Paulo, São Paulo, Brazil
2-hour pain-free
2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)
Time frame: 11 weeks
Most bothersome migraine-associated symptom
Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)
Time frame: 11 weeks
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oral - single dose