Study With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine (EDUMAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01357031|
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : December 30, 2015
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Amitriptyline Drug: Melatonin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
Melatonin 3 mg at bedtime
It will be administered Melatonin (3mg) at bed time, half an hour before the usual time of sleep of the patient.
Placebo Comparator: 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
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.
- 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).
- 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) ]
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|Instituto Israelita de Ensino e Pesquisa Albert Einstein|
|São Paulo, Brazil, 05652-000|
|Principal Investigator:||Mario F Peres, PhD||Hospital Israelita Albert Einstein|
|Responsible Party:||Mario Fernando Pietro Peres, PhD, Hospital Israelita Albert Einstein|
|Other Study ID Numbers:||
|First Posted:||May 20, 2011 Key Record Dates|
|Last Update Posted:||December 30, 2015|
|Last Verified:||December 2015|
Preventive treatment of migraine
Headache Disorders, Primary
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants
Antidepressive Agents, Tricyclic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators