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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified December 2015 by Professor Eric Visser, University of Notre Dame Australia
Sponsor:
Information provided by (Responsible Party):
Professor Eric Visser, University of Notre Dame Australia
ClinicalTrials.gov Identifier:
NCT02629536
First received: December 3, 2015
Last updated: December 9, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Migraine, Headaches Drug: N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect on Migraine Frequency of Combined Anti-oxidant Therapy: N-acetylcysteine, Vitamin E and Vitamin C (NEC): The MIGRANT Study

Resource links provided by NLM:


Further study details as provided by Professor Eric Visser, University of Notre Dame Australia:

Primary Outcome Measures:
  • Difference in mean number of migraine episodes per month between baseline and final four weeks of the study, for both study groups. [ Time Frame: 16 weeks ]
    Difference in mean number of migraine episodes per month between baseline and final four weeks of the study, for both study groups.


Secondary Outcome Measures:
  • Difference in mean migraine duration (hours) per month between baseline and final four weeks of the study, for both study groups [ Time Frame: 16 weeks ]
    Difference in mean migraine duration (hours) per month between baseline and final four weeks of the study, for both study groups

  • 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. [ Time Frame: 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.

  • Difference in mean MIDAS per month between baseline and final four weeks of the study, for both study groups. [ Time Frame: 16 weeks ]
    Migraine Disability Assessment Score (MIDAS).

  • 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. [ Time Frame: 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.

  • 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 [ Time Frame: 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

  • Number of treatment adverse events per month Number and type of treatment-related adverse effects per month. Number and type of treatment-related adverse effect [ Time Frame: 16 weeks ]
    Number of treatment adverse events per month

  • Difference in mean number of migraine days per month between baseline and final four weeks of the study, for both study groups. [ Time Frame: 16 Weeks ]
    Difference in mean number of migraine days per month between baseline and final four weeks of the study, for both study groups.

  • Responder rate: Percentage of subjects reporting ≥ 30% reduction in migraine episodes per month between baseline and final four weeks of the study, for both study groups [ Time Frame: 16 weeks ]
    Responder rate: Percentage of subjects reporting ≥ 30% reduction in migraine episodes per month between baseline and final four weeks of the study, for both study groups


Estimated Enrollment: 90
Study Start Date: March 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active-verum-NAC tablet
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
N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablet
Other Name: NEC
Placebo Comparator: Sham-placebo tablet
Intervention: Twice daily administration of sham/placebo tablet
Drug: N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablet
N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablet
Other Name: NEC

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02629536

Contacts
Contact: Eric J Visser, MBBS +61407474960 eric.visser@nd.edu.au
Contact: Elizabeth Lee-Visser, BAppSc +61407474960 ericv@iprimus.com.au

Sponsors and Collaborators
University of Notre Dame Australia
Investigators
Principal Investigator: Eric J Visser, MBBS University of Notre Dame Australia
  More Information

Responsible Party: Professor Eric Visser, Professor Eric J Visser, University of Notre Dame Australia
ClinicalTrials.gov Identifier: NCT02629536     History of Changes
Other Study ID Numbers: Churack Chair
Study First Received: December 3, 2015
Last Updated: December 9, 2015

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Acetylcysteine
N-monoacetylcystine
Antioxidants
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on September 19, 2017