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

Corfu Headache Clinic113 enrolled

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).

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.

Study Type

OBSERVATIONAL

Enrollment

113

Conditions

Migraine

Interventions

magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10DIETARY_SUPPLEMENT

Supplementation per os

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Corfu HC

Corfu, Greece

Outcomes

Primary Outcomes

Change in monthly migraine days

Change in monthly migraine days between baseline period (BL) and the third month of treatment (T3)

Time frame: 3 months

Secondary Outcomes

Mean intensity of migraine

Changes in mean intensity of migraine between baseline period (BL) and the third month of treatment (T3)

Time frame: 3 months

days with use of acute migraine medications

Changes in days with use of acute migraine medications between baseline period (BL) and the third month of treatment (T3)

Time frame: 3 months

Migraine Disability Assessment questionnaire (MIDAS)

Changes in scores of Migraine Disability Assessment questionnaire (MIDAS) during T3

Time frame: 3 months

Headache Impact Test-6 (HIT-6)

Changes in Headache Impact Test-6 (HIT-6) during T3

Time frame: 3 months

Migraine Therapy Assessment questionnaire (MTAQ)

Changes in Migraine Therapy Assessment questionnaire (MTAQ) during T3

Time frame: 3 months

Data from ClinicalTrials.gov

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