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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2020-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Migraine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10

Supplementation per os

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vivinor

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes