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

Migraine research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?


Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AmitriptylineIt will be administered Amitriptyline (25mg) once a day at bed time. Patients may keep their abortive treatment that they usually used. The drug will be encapsulated in a bottle of 30 capsules will be given to patients at every visit.

Drug:MelatoninIt will be administered Melatonin (3mg) at bed time, half an hour before the usual time of sleep of the patient.

Drug:PlaceboIt will be administered placebo capsules, identical to Melatonin (3mg) and Amitriptyline (25 mg) patients will take the study medication at bed time

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MelatoninMelatonin 3 mg at bedtime


AmitriptylineAmitriptyline 25 mg

Study Status


Start Date: May 2010

Completed Date: December 2012

Phase: Phase 3

Type: Interventional


Primary Outcome: Change in number of headache days from baseline to month 3 after treatment.

Secondary Outcome: Proportion of patients responding to treatment. Change from Baseline Phase to Double-Blind Phase in number of monthly migraine attacks, migraine intensity, migraine duration, analgesic use, weight (in kg), and tolerability reports.

Study sponsors, principal investigator, and references

Principal Investigator: Mario F Peres, PhD

Lead Sponsor: Hospital Israelita Albert Einstein

Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo

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