Cefalium® Compared to Tylenol® in the Treatment of Migraine Attacks

Inclusion Criteria:

• Subjects of both gender;

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

• 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 (IHS International Headache Society) - Annex I;

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

• Participants which are able to distinguish migraine attacks to any other type ofheadache;

• Ability to understand and consent to participate in this clinical research, expressedby signing the Informed Consent Form (ICF).

Exclusion Criteria:

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

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

• 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;

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

• Hypersensitivity to the drug components used during the study;

• Women in pregnancy or nursing period;

• 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;

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

• 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;

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

• Participants with glucose-6-phosphate dehydrogenase(G6PD) deficiency due to increasedrisk of hemolysis associated with the use of paracetamol;

• 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;

• 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: Participants with basal cell skin cancers, squamous cell, andcervical cancer in situ may be eligible;

• Subjects which uses a preventive treatment and changed the dose in the last 02 weeksbefore the screening visit (V0);

• Subjects with hepatic or renal failure;

• Subjects that has participated in clinical trial protocols in the last twelve (12)months (National Board of Health- Resolution 251 of 07 August 1997, Part III, sub-itemJ), unless the investigator considers that there may be a direct benefit to it;

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