Cefaliv® Compared to Neosaldina® in the Treatment of Migraine Attacks

Inclusion Criteria:

1. Subjects of both sexes;

2. Age older or equal to 18 and younger than 66 years if they have symptoms of migraineheadache before 50 years of age;

3. Presence of migraine headache with or without aura symptoms, at least 03 months priorto the study, the criteria defined by International Classification of HeadacheDisorders(ICHD)-II, 2004 International Headache Society(IHS) - Annex I;

4. Subjects which are experiencing 2-6 migraine attacks per month with mild to moderatepain intensity in the last 3 months prior to screening visit;

5. Subjects which are able to distinguish migraine attacks to any other type of headache;

6. Aptitude to understand and consent to participate in this clinical study, manifestedby signing the Informed Consent and Informed (IFC);

Exclusion Criteria:

1. Any clinical finding (clinical evaluation / physical) that is interpreted by theInvestigator as a risk to the participant in the clinical trial;

2. Subjects which had recent episodes of headache, with frequency equal or higher than 15daily episodes per month, 3 months prior to the screening visit;

3. Subjects with headache history defined by the ICHD-II criteria, 2004 IHS (International Headache Society) rated as:

• Typical aura with non-migraine headache;

• Typical aura without headache;

• Familial Hemiplegic Migraine (FHM);

• Sporadic Hemiplegic Migraine;

• Basilar type Migraine;

4. Any laboratorial finding that the Investigator consider a risk to the subject of thestudy;

5. Hypersensitivity to the drug components, during the study;

6. Women in pregnancy or nursing period;

7. Women in reproductive age who do not agree to use contraception acceptable [oralcontraceptives, injectable contraceptives, intrauterine device (IUD), hormonalimplants, barrier methods, hormonal patch and tubal ligation]; other than surgicallysterile (bilateral oophorectomy or hysterectomy), postmenopausal for at least one (01)years or sexual abstinence;

8. Inability to understand and answer to the functional categorical scale of the study,diary of symptoms, and not having accompanying to assist him/her;

9. History of abuse, according to the principal investigator, of the alcohol, opioids,barbiturates, benzodiazepines and illicit drugs in the last 02 years, or abuse ofdrugs for headache including ergotamines or narcotics in the last 03 months;

10. Subjects with prolonged hypotension, shock, sepsis, pheochromocytoma, hemorrhage,mechanical obstruction or perforation of the gastrointestinal tract;

11. Subjects with history of epilepsy or presence of psychiatric illness of any kind, inthe opinion of the investigator, that may interfere with adherence to treatment;

12. Subjects with a malignant disease less than five years, or for more than five years,but without documentation about the remission/cure. As example: melanoma, leukemia,lymphoma, myeloproliferative diseases and renal cell carcinoma of any length should beexcluded. Exceptions: Subjects with basal cell skin cancers, squamous cell, andcervical cancer in situ may be eligible.

13. Subjects which uses a preventive treatment and changed the dose in the last 3 monthsbefore the screening visit (V0);

14. Subjects who have made an interruption in the prophylactic treatment, in the last 30days prior to screening visit (V0);

15. Subjects with hepatic or renal failure;

16. Subjects in the research that has participated in clinical trial protocols in the lasttwelve (12) months (National Board of Health- Resolution 251 of 07 August 1997, PartIII, sub-item J), unless the investigator considers that there may be a direct benefitto it;

17. Subjects who are in prohibited medication as described in item 10.2 of the Protocol.

18. Subjects with previous diagnosis of uncontrolled hypertension;

19. Subjects with history of peripheral vascular disease; acute myocardial infarction,angina pectoris and other ischemic heart disease;

20. Subjects who have allergy to pyrazolones (eg phenazone, propyphenazone) orpyrazolidines (eg phenylbutazone,oxyphenbutazone) or who have submittedagranulocytosis in relation to any of these medicines;

21. Subjects with history of metabolic disorders such as porphyria and congenitaldeficiency of glucose-6-phosphate dehydrogenase;

22. Subjects with history of alteration in the bone marrow function or hematopoieticsystem diseases;

23. Subjects with history of bronchospasm or other allergic reactions (rhinitis,urticaria, angioedema) induced by aspirin, acetaminophen, or other anti-inflammatorymedications.