Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine.
Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine.
The purpose of this study is to determine whether a fixed-dose combination of naratriptan 2,5
 mg + naproxen 500 mg is effective and safe compared each monotherapy for the acute treatment
 of migraine.
Inclusion Criteria:

 -  Male or female patient, age in the range of 18-65 years inclusive that has onset of
 migraine before age 50;

 -  Patient has at least a 3-month history of migraine with or without aura according to
 the ICHD-II, 2004, IHS (International Headache Society) criteria;

 -  Patients experienced an average migraine headache frequency of 2-6 moderate or severe
 attacks per month in the last 03 months prior to screening visit;

 -  Patients able to distinguish his/her migraine attacks from any other types of
 headaches;

 -  Patients able to understand and consent to participate in this clinical study,
 expressed by signing the Informed Consent (IC).

 Exclusion Criteria:

 -  History of more than 6 migraine attacks/month in the last 03 months prior to screening
 visit;

 -  History of non-migraine headache frequency ≥ 15 days/month in each of the 3 months
 prior to screening;

 -  History of following migraine variants, according to the ICHD-II, 2004, IHS
 (International Headache Society): basilar migraine, aura without headache, familial
 hemiplegic migraine, sporadic hemiplegic migraine or aura with non-migraine headache;

 -  If female of childbearing potential, has a negative urine pregnancy test at Visit 0
 and doesn't use, or doesn't agree to use, for the duration of the study, a medically
 acceptable form of contraception as determined by the investigator;

 -  Woman in pregnancy or lactation period;

 -  History of epilepsy or psychiatric condition that may affect the compliance of the
 treatment;

 -  Patients in acupuncture treatment for the symptoms of migraine attacks;

 -  History or symptoms of cardiovascular disease (myocardial infarction, ischemic heart
 disease, or with Prinzmetal's angina) or has symptoms of ischemic heart disease;

 -  Suffers from peripheral vascular disease;

 -  History of cerebrovascular pathology including stroke and/or transient ischemic
 attacks;

 -  History of allergic reactions to naproxen preparations, including subjects in whom
 aspirin or other NSAID drugs induce the syndrome of asthma, rhinitis, nasal polyps or
 urticaria;

 -  Diagnosis of renal or hepatic failure;

 -  Has significant (as determined by the investigator) cardiovascular risk factors that
 may include uncontrolled high blood pressure, post-menopausal women, males over 40
 years old, hypercholesterolemia, obesity, diabetes mellitus, smoking, or a family
 history of cardiovascular disease in a 1st degree relative;

 -  Patients who have stopped or changed the dosage of the preventive treatment of
 migraine in the last 2 weeks prior the screening visit (V0), including the use of
 calcium channel blockers, tricyclic antidepressants, beta blockers or serotonergic
 medications for any other indications;

 -  Use of prohibited medicine as shown in 9.3 item of this protocol;

 -  Inability to understand and report the categorical scale debilitating functional of
 study or symptoms diary;

 -  Has abused, in the opinion of the Investigator, any of the following drugs, currently
 or within the past 2 years: opioids, alcohol, barbiturates, benzodiazepine, cocaine or
 abuse of drugs for migraine treatment including narcotics or ergotamines headache in
 the past 03 months;

 -  Hypersensitivity to naratriptan, naproxen, or any of its components;

 -  Hypersensitivity to sulfonamides;

 -  History of malignancy ≤ 5 years or > 5 years without documentation of remission /
 cure, for example, melanoma, leukemia, lymphoma, myeloproliferative disorders and
 renal cell carcinoma of any duration. Exception: Subjects with basal cell skin
 cancers, squamous cell, and cervical cancer in situ may be eligible;

 -  Participation in last one year of clinical protocols, unless it can be direct benefit
 to patient;

 -  Any finding of clinical observation (anamnesis and physical exam) laboratory
 abnormality (eg, blood glucose, blood count), disease (for example, liver,
 cardiovascular system, lung) or therapy that, in opinion of the investigator, may
 endanger the patient or interfere with the endpoints of study.