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

Study Overview
=================
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.

Official Title
-----------------
Double Blind Randomized Study Controlled by Placebo and Amitriptylin to Evaluate the Efficacy of Melatonin in the Preventive Treatment of Migraine

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Amitriptyline
* Drug: Melatonin
* Drug: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>Melatonin 3 mg at bedtime | Drug: Melatonin<br>* It will be administered Melatonin (3mg) at bed time, half an hour before the usual time of sleep of the patient.<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* It will be administered placebo capsules, identical to Melatonin (3mg) and Amitriptyline (25 mg) patients will take the study medication at bed time<br>|
| Active Comparator: Amitriptyline<br>Amitriptyline 25 mg | Drug: Amitriptyline<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline (4 weeks) and treatment period (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Baseline (4 weeks) and treatment period (12 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amitriptyline, Placebo, Melatonin, Migraine, Headache, Drug therapy, Preventive treatment of migraine