Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia

Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different associations of drugs in the treatment of patients diagnosed with tensional-type headache in accordance with International Headache Society guidelines.

• Open-label, non-inferiority, prospective, parallel group, intent to treat trial.
• Experiment duration: 56 days.
• 04 visits (days -7, 0, 28 and 56).
• Efficacy will be evaluated for 10 episodes of tension-type headache.
• Adverse events evaluation.

Inclusion Criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Tensional-type headache patients according to the International Headache Society criteria.
3. Corporal body indices < 40.

Exclusion Criteria:

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy.
4. Use of immunosuppressive drugs.
5. Alterations of laboratory selective tests.
6. Drugs or alcohol abuse