Clinical trial NCT01357031: Study With Amitriptylin to Evaluate the Efficacy of Melatonin in 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Amitriptyline
Placebo
Melatonin
Migraine
Headache
Drug therapy
Preventive treatment of migraine
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-05-20
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in number of headache days from baseline to month 3 after treatment.
timeFrame: Baseline (4 weeks) and treatment period (12 weeks)
Secondary outcomes:
measure: 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.
timeFrame: Baseline (4 weeks) and treatment period (12 weeks)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Israelita de Ensino e Pesquisa Albert Einstein
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Mario F Peres, PhD
role: PRINCIPAL_INVESTIGATOR
References: