Back to resultsStudy With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine (EDUMAP)
Primary Purpose
Migraine
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Amitriptyline
Melatonin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Amitriptyline, Placebo, Melatonin, Migraine, Headache, Drug therapy, Preventive treatment of migraine
Eligibility 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.
Sites / Locations
- Instituto Israelita de Ensino e Pesquisa Albert Einstein
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Melatonin
Placebo
Amitriptyline
Arm Description
Melatonin 3 mg at bedtime
Placebo
Amitriptyline 25 mg
Outcomes
Primary Outcome Measures
Change in number of headache days from baseline to month 3 after treatment.
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.
Full Information
NCT ID
NCT01357031
First Posted
May 14, 2010
Last Updated
December 29, 2015
Sponsor
Hospital Israelita Albert Einstein
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01357031
Brief Title
Study With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine
Acronym
EDUMAP
Official Title
Double Blind Randomized Study Controlled by Placebo and Amitriptylin to Evaluate the Efficacy of Melatonin in the Preventive Treatment of Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Israelita Albert Einstein
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Amitriptyline, Placebo, Melatonin, Migraine, Headache, Drug therapy, Preventive treatment of migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Melatonin
Arm Type
Experimental
Arm Description
Melatonin 3 mg at bedtime
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Amitriptyline
Arm Type
Active Comparator
Arm Description
Amitriptyline 25 mg
Intervention Type
Drug
Intervention Name(s)
Amitriptyline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
It will be administered Melatonin (3mg) at bed time, half an hour before the usual time of sleep of the patient.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
It will be administered placebo capsules, identical to Melatonin (3mg) and Amitriptyline (25 mg) patients will take the study medication at bed time
Primary Outcome Measure Information:
Title
Change in number of headache days from baseline to month 3 after treatment.
Description
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).
Time Frame
Baseline (4 weeks) and treatment period (12 weeks)
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario F Peres, PhD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Israelita de Ensino e Pesquisa Albert Einstein
City
São Paulo
ZIP/Postal Code
05652-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Study With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine
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