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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Mario Fernando Pietro Peres, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT01357031
First received: May 14, 2010
Last updated: December 29, 2015
Last verified: December 2015
  Purpose
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 Intervention Phase
Migraine
Drug: Amitriptyline
Drug: Melatonin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Hospital Israelita Albert Einstein:

Primary Outcome Measures:
  • Change in number of headache days from baseline to month 3 after treatment. [ Time Frame: Baseline (4 weeks) and treatment period (12 weeks) ] [ Designated as safety issue: Yes ]
    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:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 192
Study Start Date: May 2010
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357031

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     History of Changes
Other Study ID Numbers: EDUMAP 
Study First Received: May 14, 2010
Last Updated: December 29, 2015
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by 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
Melatonin
Amitriptyline, perphenazine drug combination
Amitriptyline
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
Antipsychotic Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on December 08, 2016