Study With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness of melatonin 3 mg compared to placebo and amitriptyline 25 mg in the preventive treatment of migraine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Israelita Albert Einstein
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination; Melatonin

Criteria

Inclusion Criteria:

• Man or woman 18 to 65 years of age.

• Meets diagnostic criteria criteria of International Headache Society (IHS) 2004 (2) for migraine with and / or without aura.

• Frequency from 2 to 8 migraine attacks per month

• Top of crisis over a year and age of onset less than 50 years of age.

• Patients want to participate in the study, and able to give informed consent.

• If women, the patient must be willing to use an acceptable method of birth control (eg, a hormonal contraceptive, intrauterine device, diaphragm with spermicide or condom with spermicide, or refer abstinence).

• Patient able and willing to remain on their medications throughout the study.

• Accept the guidelines of the study by filling out the diary and clinical scales.

Exclusion Criteria:

• Any medical condition that places the patient at risk with its exposure to melatonin or amitryptiline

• Use of alcohol and drugs.

• Be receiving prophylactic medication in the last three months.

• History of hemiplegic migraine, basilar, Ophthalmoplegic or stroke.

• Headache secondary to head trauma or a whiplash neck injury (whiplash).

• Pregnant or breastfeeding. Women planning to become pregnant or of childbearing age without acceptable method of contraception.

• Women who began taking oral contraceptives or who switched their oral contraceptive regimen in the 6 months prior to the start of the study.

• Allergy or known hypersensitivity to study medication or its components.

• Participation in another clinical study one month before inclusion.