Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01357031
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : December 30, 2015
Sponsor:
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  ICMJE May 14, 2010
First Posted Date  ICMJE May 20, 2011
Last Update Posted Date December 30, 2015
Study Start Date  ICMJE May 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Study With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2011)
192
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01357031
Other Study ID Numbers  ICMJE EDUMAP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mario Fernando Pietro Peres, Hospital Israelita Albert Einstein
Study Sponsor  ICMJE Hospital Israelita Albert Einstein
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Principal Investigator: Mario F Peres, PhD Hospital Israelita Albert Einstein
PRS Account Hospital Israelita Albert Einstein
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP