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

Corfu Headache Clinic

Status: Completed

Conditions: Migraine

Treatments: Dietary Supplement: magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10

Study type: Observational

Funder types: Other

Identifiers

NCT04463875

Corfu HC

Details and patient eligibility

About

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 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.

Enrollment: 113 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.