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

NCT02629536 | Unknown Phase 3

• 1 other identifier: Churack Chair
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Migraine, Headaches

Outcome Measures

Primary Outcomes (1)

• Difference in mean number of migraine episodes per month between baseline and final four weeks of the study, for both study groups.

  Difference in mean number of migraine episodes per month between baseline and final four weeks of the study, for both study groups.

  16 weeks

Secondary Outcomes (8)

• Difference in mean migraine duration (hours) per month between baseline and final four weeks of the study, for both study groups

  16 weeks

• Difference in mean migraine severity score per month (categorical scale; 0 = nil, 1 = mild, 2 = moderate, 3 = severe) between baseline and final four weeks of the study, for both study groups.

  16 weeks

• Difference in mean MIDAS per month between baseline and final four weeks of the study, for both study groups.

  16 weeks

• Difference in mean MSQ score per month between baseline and final four weeks of the study, for both study groups. Migraine Specific Quality of Life Questionnaire (MSQ, Version 2.1) score.

  16 weeks

• Difference in mean HRQOL score per month between baseline and final four weeks of the study, for both study groups.Health Related Quality of Life (HRQOL) score

  16 weeks

Study Arms (2)

Active-verum-NAC tablet

EXPERIMENTAL

Intervention: Twice-daily administration of N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablets

Drug: N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablet

Sham-placebo tablet

PLACEBO COMPARATOR

Intervention: Twice daily administration of sham/placebo tablet

Drug: N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablet

Interventions

N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablet DRUG

N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablet

Also known as: NEC

Active-verum-NAC tablet; Sham-placebo tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Notre Dame Australia: lead

MeSH Terms

Conditions

Migraine Disorders

Interventions

Acetylcysteine; Tablets

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Eric J Visser, MBBS

  University of Notre Dame Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric J Visser, MBBS

CONTACT

+61407474960; eric.visser@nd.edu.au

Elizabeth Lee-Visser, BAppSc

CONTACT

+61407474960; ericv@iprimus.com.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Eric J Visser

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 14, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 14, 2015

Record last verified: 2015-12