A Phase II randomised double-blind placebo-controlled clinical trial of vitamin supplementation in females diagnosed with migraine with aura, incorporating methylene tetrahydrofolate reductase (MTHFR) genotype analysis, to determine whether vitamin therapy is an effective complementary or alternative therapy for reducing migraine disability.

Griffith University0 个研究点目标入组 250 人开始时间: 2009年5月15日最近更新: 2020年1月13日

适应症

试验速览

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•Female aged 18 to 65 years of age.
•Have a diagnosis of migraine with aura (MA) according to International Headache Society Criteria.
•Unrelated by first degree - we hypothesise that our outcome variable, response to vitamin therapy, is influenced by inherited factors, so genetic independence of participants is important.
•Suffer at least 4 migraine episodes per year.
•Of Caucasian ancestral background.
•Participants with adequate venous access in their left and right arms to allow collection of a number of blood samples via venepuncture.
•Fluent in the English language.
•Have voluntarily given written informed consent to participate in this study.
•Be able to attend the Genomics Research Centre (GRC) clinical trials facility on the Gold Coast.

•Participated in the migraine-vitamin trial pilot study.
•Has a clinically recognised co-morbid disease e.g. vascular disease, depression, epilepsy.
•Other severe illness that might interfere with assessment or hamper patient’s ability to complete the study e.g. compliance.
•Pregnancy or planned pregnancy in the study period.
•History of any psychiatric illness.
•Inability to comply with treatment regime or attend clinic assessments.
•Participation in another clinical trial or received experimental therapy within last 30 days.
•Donated or lost a significant amount of blood (e.g. 550 mL) within the past 12 weeks.
•Persons already taking vitamin B and/or folic acid supplementation.
•Persons who have ever been diagnosed with cancer.
•Persons who have three or more first degree relatives who have been diagnosed with cancer.

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