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

Sponsor

Corfu Headache Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT04463875

Collaborator

(none)

113

Enrollment

Location

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Migraine	Dietary Supplement: magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

113 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Actual Study Start Date :

Apr 1, 2018

Actual Primary Completion Date :

Apr 30, 2020

Actual Study Completion Date :

May 31, 2020

Outcome Measures

Primary Outcome Measures

Change in monthly migraine days [3 months]
Change in monthly migraine days between baseline period (BL) and the third month of treatment (T3)

Secondary Outcome Measures

Mean intensity of migraine [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 [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) [3 months]
Changes in scores of Migraine Disability Assessment questionnaire (MIDAS) during T3
Headache Impact Test-6 (HIT-6) [3 months]
Changes in Headache Impact Test-6 (HIT-6) during T3
Migraine Therapy Assessment questionnaire (MTAQ) [3 months]
Changes in Migraine Therapy Assessment questionnaire (MTAQ) during T3

Other Outcome Measures

Migraine responders [3 months]
Those with ≥50% reduction in monthly migraine days during T3 compared to BL were considered Vivinor®-responders.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.