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

Migraine Clinical Trial

— EDUMAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357031
• Other study ID #: EDUMAP
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2010
• Last updated: December 29, 2015
• Start date: May 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2015
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.
• Melatonin
It will be administered Melatonin (3mg) at bed time, half an hour before the usual time of sleep of the patient.
• Placebo
It will be administered placebo capsules, identical to Melatonin (3mg) and Amitriptyline (25 mg) patients will take the study medication at bed time

Locations

Country	Name	City	State
Brazil	Instituto Israelita de Ensino e Pesquisa Albert Einstein	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes