Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis

Overview

To investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention, by an observational, prospective real-world study in 113 Greek patients with episodic migraine that were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL)and the third month of treatment (T3).

Full Title of Study: “Real World, Open Label Prospective Experience of Supplementation With a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2020

Detailed Description

To investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention. An observational, prospective real-world study. After a one-month baseline period, Vivinor® was introduced in 113 Greek patients with episodic migraine that were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL)and the third month of treatment (T3). Secondary endpoints included changes in mean intensity of migraine and in days with use of acute migraine medications. Changes in scores of Migraine Disability Assessment questionnaire (MIDAS), Headache Impact Test-6 (HIT-6), Migraine Therapy Assessment questionnaire (MTAQ), MSQ-QOL (Migraine-Specific Quality of life questionnaire), HADS (Hospital Anxiety and Depression Scale) were also evaluated. Those with ≥50% reduction in monthly migraine days during T3 compared to BL were considered Vivinor®-responders.

Interventions

  • Dietary Supplement: magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10
    • Supplementation per os

Clinical Trial Outcome Measures

Primary Measures

  • Change in monthly migraine days
    • Time Frame: 3 months
    • Change in monthly migraine days between baseline period (BL) and the third month of treatment (T3)

Secondary Measures

  • Mean intensity of migraine
    • Time Frame: 3 months
    • Changes in mean intensity of migraine between baseline period (BL) and the third month of treatment (T3)
  • days with use of acute migraine medications
    • Time Frame: 3 months
    • Changes in days with use of acute migraine medications between baseline period (BL) and the third month of treatment (T3)
  • Migraine Disability Assessment questionnaire (MIDAS)
    • Time Frame: 3 months
    • Changes in scores of Migraine Disability Assessment questionnaire (MIDAS) during T3
  • Headache Impact Test-6 (HIT-6)
    • Time Frame: 3 months
    • Changes in Headache Impact Test-6 (HIT-6) during T3
  • Migraine Therapy Assessment questionnaire (MTAQ)
    • Time Frame: 3 months
    • Changes in Migraine Therapy Assessment questionnaire (MTAQ) during T3

Participating in This Clinical Trial

Inclusion Criteria

  • established diagnosis of episodic migraine with or without aura for more than one year prior to study entry – evidence of 4-14 migraine days per month during the last trimester prior to screening – participants may had been either treatment- naive or not suitable for or had failed previous migraine pharmacological prophylactic treatments – were able to fully understand protocol and study information provided by the investigators. – enrolled patients should take no other preventive treatment or use any other migraine prophylactic method during the three months before entering the study and throughout the study period. Exclusion Criteria:

  • older than 50 years of age at migraine onset – evidence of MOH – pregnant or nursing females – history of tension-type, cluster or hemiplegic headache – history of severe anaphylactic reactions to any of the intervention's ingredients – evidence of severe systemic diseases – history or evidence of major psychiatric disorder.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Corfu Headache Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: KONSTANTINOS SPINGOS, Dr. – Corfu Headache Clinic
  • Overall Official(s)
    • Michail Michail, MD, MSc, PhD, Principal Investigator, Mediterraneo Hospital, Glyfada, Greece

References

Holland S, Silberstein SD, Freitag F, Dodick DW, Argoff C, Ashman E; Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012 Apr 24;78(17):1346-53. doi: 10.1212/WNL.0b013e3182535d0c.

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