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
|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|
|Primary Completion Date :||December 2011|
|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) ]
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|