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

• ClinicalTrials.gov Identifier: NCT01357031
• Recruitment Status: Completed
• First Posted: May 20, 2011
• Last Update Posted: December 30, 2015
• Sponsor: Hospital Israelita Albert Einstein
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Information provided by (Responsible Party): Mario Fernando Pietro Peres, Hospital Israelita Albert Einstein

Tracking Information

• First Submitted Date: May 14, 2010
• First Posted Date: May 20, 2011
• Last Update Posted Date: December 30, 2015
• Study Start Date: May 2010
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 19, 2011)

Change in number of headache days from baseline to month 3 after treatment. [ Time Frame: Baseline (4 weeks) and treatment period (12 weeks) ]

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).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 29, 2015): 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. [ Time Frame: Baseline (4 weeks) and treatment period (12 weeks) ]
• Original Secondary Outcome Measures (submitted: May 19, 2011): 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. [ Time Frame: Baseline (4 weeks) and treatment period (12 weeks) ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Migraine

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

Study Arms

• Experimental: Melatonin
  Melatonin 3 mg at bedtime
  Intervention: Drug: Melatonin
• Placebo Comparator: Placebo
  Placebo
  Intervention: Drug: Placebo
• Active Comparator: Amitriptyline
  Amitriptyline 25 mg
  Intervention: Drug: Amitriptyline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 19, 2011): 192
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01357031
• Other Study ID Numbers: EDUMAP
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mario Fernando Pietro Peres, Hospital Israelita Albert Einstein
• Original Responsible Party: MARIO FERNANDO PRIETO PERES, INSTITUTO ISRAELITA DE ENSINO E PESQUISA ALBERT EINSTEIN
• Current Study Sponsor: Hospital Israelita Albert Einstein
• Original Study Sponsor: Same as current
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

• Principal Investigator: Mario F Peres, PhD; Hospital Israelita Albert Einstein

• PRS Account: Hospital Israelita Albert Einstein
• Verification Date: December 2015