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

NCT01357031 | Completed Phase 3 DMC

• 1 other identifier: EDUMAP
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Amitriptyline; Placebo; Melatonin; Migraine; Headache; Drug therapy; Preventive treatment of migraine

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Study Arms (3)

Melatonin

EXPERIMENTAL

Melatonin 3 mg at bedtime

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Amitriptyline

ACTIVE COMPARATOR

Amitriptyline 25 mg

Drug: Amitriptyline

Interventions

Amitriptyline 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.

Amitriptyline

Melatonin DRUG

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

Melatonin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto Israelita de Ensino e Pesquisa Albert Einstein

São Paulo, São Paulo, 05652-000, Brazil

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Amitriptyline; Melatonin

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mario F Peres, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 20, 2011
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: December 30, 2015

Record last verified: 2015-12

Locations

BR (1)