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

Last updated: December 29, 2015
Sponsor: Hospital Israelita Albert Einstein
Overall Status: Completed

Phase

3

Condition

Migraine (Adult)

Oral Facial Pain

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01357031
EDUMAP
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orcondom 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

Exclusion Criteria:

  • Any medical condition that places the patient at risk with its exposure to melatoninor 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 agewithout acceptable method of contraception.

  • Women who began taking oral contraceptives or who switched their oral contraceptiveregimen 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.

Study Design

Total Participants: 192
Study Start date:
May 01, 2010
Estimated Completion Date:
December 31, 2012

Study 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.

Connect with a study center

  • Instituto Israelita de Ensino e Pesquisa Albert Einstein

    São Paulo, 05652-000
    Brazil

    Site Not Available

  • Instituto Israelita de Ensino e Pesquisa Albert Einstein

    São Paulo, 05652-000
    Brazil

    Site Not Available

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