Trial | NCT01357031  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    192
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.
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.
Study Started
May 31
2010
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2012
Last Update
Dec 30
2015
Estimate

Drug Amitriptyline

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.

Drug Melatonin

It will be administered Melatonin (3mg) at bed time, half an hour before the usual time of sleep of the patient.

Drug Placebo

It will be administered placebo capsules, identical to Melatonin (3mg) and Amitriptyline (25 mg) patients will take the study medication at bed time

Melatonin Experimental

Melatonin 3 mg at bedtime

Placebo Placebo Comparator

Placebo

Amitriptyline Active Comparator

Amitriptyline 25 mg

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.
No Results Posted