Study With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine (EDUMAP)
Recruitment status was Recruiting
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.
|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|
- 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).
- 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 ]
|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)|
Melatonin 3 mg at bedtime
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.
Placebo Comparator: Placebo
Active Comparator: Amitriptyline
Amitriptyline 25 mg
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357031
|Instituto Israelita de Ensino e Pesquisa Albert Einstein||Recruiting|
|São Paulo, Brazil, 05652-000|
|Contact: André L Gonçalves, PhD student 00551135898237 firstname.lastname@example.org|
|Principal Investigator: Mario Fernando P Peres, PhD|
|Sub-Investigator: André L Gonçalves, PhD student|
|Principal Investigator:||Mario F Peres, PhD||Hospital Israelita Albert Einstein|