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

Overview

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.

Full Title of Study: “Double Blind Randomized Study Controlled by Placebo and Amitriptylin to Evaluate the Efficacy of Melatonin in the Preventive Treatment of Migraine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2011

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Melatonin
    • Melatonin 3 mg at bedtime
  • Placebo Comparator: Placebo
    • Placebo
  • Active Comparator: Amitriptyline
    • Amitriptyline 25 mg

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Israelita Albert Einstein
  • Collaborator
    • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mario Fernando Pietro Peres, PhD – Hospital Israelita Albert Einstein
  • Overall Official(s)
    • Mario F Peres, PhD, Principal Investigator, Hospital Israelita Albert Einstein

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