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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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; 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.

Outcome Measures

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) ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Brazil

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

Investigators

• Principal Investigator: Mario F Peres, PhD; Hospital Israelita Albert Einstein

More Information

• 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
• Last Update Posted: December 30, 2015
• Last Verified: December 2015

Keywords provided by Mario Fernando Pietro Peres, Hospital Israelita Albert Einstein:

Amitriptyline; Placebo; Melatonin; Migraine; Headache; Drug therapy; Preventive treatment of migraine

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amitriptyline; Melatonin; Antioxidants; 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; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Agents; Neurotransmitter Agents