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

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ClinicalTrials.gov Identifier: NCT01357031
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : December 30, 2015
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Mario Fernando Pietro Peres, Hospital Israelita Albert Einstein

Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Amitriptyline Drug: Melatonin Drug: Placebo Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Randomized Study Controlled by Placebo and Amitriptylin to Evaluate the Efficacy of Melatonin in the Preventive Treatment of Migraine
Study Start Date : May 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Melatonin
Melatonin 3 mg at bedtime
Drug: Melatonin
It will be administered Melatonin (3mg) at bed time, half an hour before the usual time of sleep of the patient.

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

Active Comparator: Amitriptyline
Amitriptyline 25 mg
Drug: Amitriptyline
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.

Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357031

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Instituto Israelita de Ensino e Pesquisa Albert Einstein
São Paulo, Brazil, 05652-000
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Fundação de Amparo à Pesquisa do Estado de São Paulo
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Principal Investigator: Mario F Peres, PhD Hospital Israelita Albert Einstein
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Responsible Party: Mario Fernando Pietro Peres, PhD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT01357031    
Other Study ID Numbers: EDUMAP
First Posted: May 20, 2011    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015
Keywords provided by Mario Fernando Pietro Peres, Hospital Israelita Albert Einstein:
Drug therapy
Preventive treatment of migraine
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Neurotransmitter Agents