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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Hospital Israelita Albert Einstein.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT01357031
First received: May 14, 2010
Last updated: May 19, 2011
Last verified: January 2009
  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,monthly migraine days, number of days/month requiring rescue medication. [ Time Frame: Baseline (4 weeks) and treatment period (12 weeks) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 192
Study Start Date: January 2009
Estimated Study Completion Date: December 2012
Estimated 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 with a group of 64 patients each and the respective placebo control group, also with 64 patients. Melatonin (3mg) will be used in dosage of once daily, during the night, half an hour before the usual time of sleep of the patient. Patients may keep their abortive treatment that they usually used. The drugs and placebo will be encapsulated in a bottle of 30 capsules will be given to patients at every visit, and be directed to the importance of returning the remaining capsules for under control of grip.
Other Names:
  • Amitriptyline
  • Melatonin
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Active Comparator: Amitriptyline
Amitriptyline 25 mg
Drug: Amitriptyline
It will be administered 25mg amitriptyline with a group of 64 patients each and the respective placebo control group, also with 64 patients. Amitriptyline (25mg) is administered once a day in the night, as well as placebo. Patients may keep their abortive treatment that they usually used. The drugs and placebo will be encapsulated in a bottle of 30 capsules will be given to patients at every visit, and be directed to the importance of returning the remaining capsules for under control of grip.
Other Names:
  • Amitriptyline
  • Melatonin

Detailed Description:

The investigators propose a study of 192 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 3mg 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
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 Recruiting
São Paulo, Brazil, 05652-000
Contact: André L Gonçalves, PhD student    00551135898237    goncalvesnp@yahoo.com.br   
Principal Investigator: Mario Fernando P Peres, PhD         
Sub-Investigator: André L Gonçalves, PhD student         
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

No publications provided

Responsible Party: MARIO FERNANDO PRIETO PERES, INSTITUTO ISRAELITA DE ENSINO E PESQUISA ALBERT EINSTEIN
ClinicalTrials.gov Identifier: NCT01357031     History of Changes
Other Study ID Numbers: EDUMAP
Study First Received: May 14, 2010
Last Updated: May 19, 2011
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
Amitriptyline
Amitriptyline, perphenazine drug combination
Melatonin
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Antioxidants
Protective Agents

ClinicalTrials.gov processed this record on July 22, 2014