Clinical trial NCT04463875: Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis
Official title: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: episodic migraine
supplement
Vivinor
magnesium
vitamin B2
andrographis paniculata
coenzyme Q10
Lead sponsor: Corfu Headache Clinic
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with a documented history of episodic migraine with or without aura for more than the 12 months prior to screening, according to the criteria of the International Classification of Headaches Disorders-III (IHS, 2013)

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in monthly migraine days
timeFrame: 3 months
Secondary outcomes:
measure: Mean intensity of migraine
timeFrame: 3 months
measure: days with use of acute migraine medications
timeFrame: 3 months
measure: Migraine Disability Assessment questionnaire (MIDAS)
timeFrame: 3 months
measure: Headache Impact Test-6 (HIT-6)
timeFrame: 3 months
measure: Migraine Therapy Assessment questionnaire (MTAQ)
timeFrame: 3 months
Other outcomes:
measure: Migraine responders
timeFrame: 3 months
Locations:
city: Corfu
country: Greece
facility: Corfu HC
Study officials:
affiliation: Mediterraneo Hospital, Glyfada, Greece
name: Michail Michail, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.