Effect on Migraine Frequency of Combined Anti-oxidant Therapy: The MIGRANT Study.

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Migraine affects 15% of Western Australians and is a leading cause of suffering and disability in our community (1,2). 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 3 months, will reduce migraine attacks. This safe vitamin-based therapy has never been studied and if effective, will play an important role in migraine prevention.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Notre Dame Australia
• Treatments: Acetylcysteine; Antioxidants; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Migraine (with or without aura) according to IHS 2013 criteria.

• Migraine of at least one year's duration, with onset before 50 years of age.

• Two-to-eight migraine episodes, and less than six 'other' headache types per month, averaged over 12 weeks prior to recruitment.

• Subjects able to clearly distinguish between migraine and 'other' headache types.

• Cognitive and English language skills allowing completion of headache diaries and self-administration of trial drugs.

Exclusion Criteria:

• Participation in a concurrent research trial.

• Chronic daily headaches, according to IHS 2013 criteria.

• Medication-overuse headache and/or other primary headache disorders, according to IHS 2013 criteria.

• Change in migraine treatment in the twelve weeks prior to, or during the study.

• Taking ≥ 2 migraine prevention drugs.

• Failure to respond in ≥ 2 previous migraine prevention trials.

• Taking NAc, VitE or VitC supplements in the 12 weeks prior to the study.

• Pregnancy, or risk of pregnancy during the study; female of reproductive age not taking medically prescribed contraception; breast feeding.

• Adverse reactions to NAc, VitE or VitC preparations; VitC deficiency.

• Renal dysfunction (eGFR ≤ 30 ml/min/1.73m2), liver dysfunction (ALT or AST > 300 IU/L).

• Clinical risks associated with bleeding, coagulopathy, warfarin therapy.

• Haemochromatosis, glucose-6-phosphate dehydrogenase deficiency.

• Daily opioid use in the 12 weeks prior to or during the study.

• Substance abuse, dependence or addiction during the study.

• Psychosis, bipolar affective disorder.