Migraine Clinical Trial
— EDUMAPOfficial title:
Double Blind Randomized Study Controlled by Placebo and Amitriptylin to Evaluate the Efficacy of Melatonin in the Preventive Treatment of Migraine
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.
Status | Completed |
Enrollment | 192 |
Est. completion date | December 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto Israelita de Ensino e Pesquisa Albert Einstein | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital Israelita Albert Einstein | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Yes |
Secondary | 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) | Yes |
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