None listed
Conditions
Brief summary
Effects on Migraine Frequency using Combined Anti-oxidant Therapy: N-acetylcysteine, Vitamin E and Vitamin C (NEC): The MIGRANT study. Lay title: Using a combination of anti-oxidant supplements N-acetylcysteine, Vitamin E and Vitamin C to reduce the frequency of migraines. Summary: Migraine affects 15% of Western Australians and is a leading cause of suffering and disability in our community. Research suggests that inflammation of the brain’s coverings (meninges) by nerve cell inflammation and the release of ‘free radicals’, is a cause of migraine. N-acetylcysteine, Vitamin E and Vitamin C are powerful anti-oxidants (free-radical scavengers) that reduce brain inflammation and nerve activity. It is therefore possible these anti-oxidants could reduce the number and severity of migraines. We will study 90 subjects to see if a combination of N-acetylcysteine 600 mg, Vitamin E 250 IU and vitamin C 500 mg (NEC) taken twice daily for 12 weeks, will reduce migraine attacks. This safe vitamin-based therapy has never been studied and if effective, will play an important role in migraine prevention.
Interventions
We will study 84 subjects to see if a combination of N-acetylcysteine 600 mg, Vitamin E 250 IU and vitamin C 500 mg (NEC) taken twice daily as oral tablets for 12 weeks, will reduce migraine attacks frequency.
Compliance will be monitored with pill count of returned medication containers and diary filled in by subjects, with 4 weekly investigator compliance interview.
Sponsors
University of Notre Dame Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed