Study With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine (EDUMAP)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Hospital Israelita Albert Einstein.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospital Israelita Albert Einstein
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT01357031
First received: May 14, 2010
Last updated: May 19, 2011
Last verified: January 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: Amitriptyline Drug: Melatonin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double Blind Randomized Study Controlled by Placebo and Amitriptylin to Evaluate the Efficacy of Melatonin in the Preventive Treatment of Migraine |
Resource links provided by NLM:
Further study details as provided by Hospital Israelita Albert Einstein:
Primary Outcome Measures:
- Change in number of headache days from baseline to month 3 after treatment. [ Time Frame: Baseline (4 weeks) and treatment period (12 weeks) ] [ Designated as safety issue: Yes ]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).
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 192 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Melatonin
Melatonin 3 mg at bedtime
|
Drug: Melatonin
It will be administered melatonin 3mg with a group of 64 patients each and the respective placebo control group, also with 64 patients. Melatonin (3mg) will be used in dosage of once daily, during the night, half an hour before the usual time of sleep of the patient. Patients may keep their abortive treatment that they usually used. The drugs and placebo will be encapsulated in a bottle of 30 capsules will be given to patients at every visit, and be directed to the importance of returning the remaining capsules for under control of grip.
Other Names:
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Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo
|
|
Active Comparator: Amitriptyline
Amitriptyline 25 mg
|
Drug: Amitriptyline
It will be administered 25mg amitriptyline with a group of 64 patients each and the respective placebo control group, also with 64 patients. Amitriptyline (25mg) is administered once a day in the night, as well as placebo. Patients may keep their abortive treatment that they usually used. The drugs and placebo will be encapsulated in a bottle of 30 capsules will be given to patients at every visit, and be directed to the importance of returning the remaining capsules for under control of grip.
Other Names:
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Detailed Description:
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 and amitriptyline.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357031
Locations
| Brazil | |
| Instituto Israelita de Ensino e Pesquisa Albert Einstein | Recruiting |
| São Paulo, Brazil, 05652-000 | |
| Contact: André L Gonçalves, PhD student 00551135898237 goncalvesnp@yahoo.com.br | |
| Principal Investigator: Mario Fernando P Peres, PhD | |
| Sub-Investigator: André L Gonçalves, PhD student | |
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
| Principal Investigator: | Mario F Peres, PhD | Hospital Israelita Albert Einstein |
More Information
No publications provided
| Responsible Party: | MARIO FERNANDO PRIETO PERES, INSTITUTO ISRAELITA DE ENSINO E PESQUISA ALBERT EINSTEIN |
| ClinicalTrials.gov Identifier: | NCT01357031 History of Changes |
| Other Study ID Numbers: | EDUMAP |
| Study First Received: | May 14, 2010 |
| Last Updated: | May 19, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Hospital Israelita Albert Einstein:
|
Amitriptyline Placebo Melatonin Migraine |
Headache Drug therapy Preventive treatment of migraine |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Amitriptyline Amitriptyline, perphenazine drug combination Melatonin Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Antioxidants Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013