Effect on Migraine Frequency of using Combined Anti-oxidant Therapy: N-acetylcysteine, Vitamin E and Vitamin C (NEC) in adults with frequent migraine: The MIGRANT study.

niversity of Notre Dame Australia0 个研究点目标入组 84 人开始时间: 2015年12月8日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Migraine of at least one year’s duration, with onset before 50 years of age.
•2. Two-to-eight migraine episodes, and less than six ‘other’ headache types per month, averaged over 12 weeks prior to recruitment.
•3. Subjects able to clearly distinguish between migraine and ‘other’ headache types.
•4. Cognitive and English language skills allowing completion of headache diaries and self-administration of trial drugs.

•Participation in a concurrent research trial.
•1. Chronic daily headaches, according to IHS 2013..Headache Classification Committee of the International Headache Society (IHS).The International Classification of Headache Disorders (3rd Ed) (beta version). Cephalalgia 2013; 33(9): 629–808.
•2. Medication-overuse headache and/or other primary headache disorders, according to IHS 2013 criteria.
•3. Change in migraine treatment in the twelve weeks prior to, or during the study.
•4. Taking 2 or more migraine prevention drugs, .
•5. Failure to respond in 2 or more previous migraine prevention trials.
•6. Taking NAc, VitE or VitC supplements in the 12 weeks prior to the study.
•7. Pregnancy, or risk of pregnancy during the study; female of reproductive age not taking medically prescribed contraception; breast feeding.
•8. Adverse reactions to NAc, VitE or VitC preparations; VitC deficiency.
•9. Renal dysfunction (eGFR less than 30 ml/min/1.73m2), liver dysfunction (ALT or AST > 300 IU/L).
•10. Clinical risks associated with bleeding, coagulopathy, warfarin therapy.
•11. Haemochromatosis, glucose-6-phosphate dehydrogenase deficiency.
•12. Daily opioid use in the 12 weeks prior to or during the study.
•13. Substance abuse, dependence or addiction during the study.
•14. Psychosis, bipolar affective disorder.

发起方

niversity of Notre Dame Australia