Study With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine
Information source: Hospital Israelita Albert Einstein
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: Amitriptyline (Drug); Melatonin (Drug); Placebo (Drug)
Phase: Phase 3
Sponsored by: Hospital Israelita Albert Einstein
Official(s) and/or principal investigator(s):
Mario F Peres, PhD, Principal Investigator, Affiliation: Hospital Israelita Albert Einstein
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.
Official title: Double Blind Randomized Study Controlled by Placebo and Amitriptylin to Evaluate the Efficacy of Melatonin in the Preventive Treatment of Migraine
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in number of headache days from baseline to month 3 after treatment.
Secondary outcome: Proportion of patients responding to treatment. Change from Baseline Phase to Double-Blind Phase in number of monthly migraine attacks,monthly migraine days, number of days/month requiring rescue medication.
The investigators propose a study of 192 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 3mg 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
Minimum age: 18 Years.
Maximum age: 65 Years.
- 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.
- Any medical condition that places the patient at risk with its exposure to melatonin
- 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.
Locations and Contacts
Instituto Israelita de Ensino e Pesquisa Albert Einstein, São Paulo 05652-000, Brazil; Recruiting
André L Gonçalves, PhD student, Phone: 00551135898237, Email: email@example.com
Mario Fernando P Peres, PhD, Principal Investigator
André L Gonçalves, PhD student, Sub-Investigator
Starting date: January 2009
Last updated: May 19, 2011