Phase
Condition
Migraine (Adult)
Oral Facial Pain
Pain (Pediatric)
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 orcondom 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
Exclusion Criteria:
Any medical condition that places the patient at risk with its exposure to melatoninor 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 agewithout acceptable method of contraception.
Women who began taking oral contraceptives or who switched their oral contraceptiveregimen 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.
Study Design
Study Description
Connect with a study center
Instituto Israelita de Ensino e Pesquisa Albert Einstein
São Paulo, 05652-000
BrazilSite Not Available
Instituto Israelita de Ensino e Pesquisa Albert Einstein
São Paulo, 05652-000
BrazilSite Not Available
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