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Completed

NCT Number: NCT01357031

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Israelita de Ensino e Pesquisa Albert Einstein

São Paulo, 05652-000, Brazil

About this study

The investigators propose a study of patients with migraine (episodic) with or without aura, according to the criteria of the International Headache Society (IHS) 2004. This will be a randomized clinical trial, prospective, double-blind, placebo-controlled, comparing the efficacy of melatonin 3 mg and amitriptyline 25 mg for migraine prevention. The length of the inclusion of the study will be 24 months. This study's general objective is: to evaluate the effectiveness of melatonin in the preventive treatment of migraine and compare it to placebo and amitriptyline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amitriptyline

Drug

It 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.

Melatonin

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Change in number of headache days from baseline to month 3 after treatment.

    Time frame: Baseline (4 weeks) and treatment period (12 weeks)

    This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of melatonin 3 mg, amitriptyline 25 mg versus placebo in the prevention of migraine headaches. The study consists of 2 phases: Baseline Phase (4 weeks) and Double-Blind Phase (patients are randomized to receive melatonin, amitriptyline or placebo for a total of 12 weeks).

Secondary outcomes

  1. 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.

    Time frame: Baseline (4 weeks) and treatment period (12 weeks)

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Double Blind Randomized Study Controlled by Placebo and Amitriptylin to Evaluate the Efficacy of Melatonin in the Preventive Treatment of Migraine

Acronym: EDUMAP

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
May 20, 2011
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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