MedDataX Logo

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

NCT ID: NCT01357031

Last Updated: 2015-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Amitriptyline Placebo Melatonin Migraine Headache Drug therapy Preventive treatment of migraine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Melatonin

Melatonin 3 mg at bedtime

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

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

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Amitriptyline

Amitriptyline 25 mg

Group Type ACTIVE_COMPARATOR

Amitriptyline

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Melatonin

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mario Fernando Pietro Peres

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mario F Peres, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto Israelita de Ensino e Pesquisa Albert Einstein

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EDUMAP

Identifier Type: -

Identifier Source: org_study_id