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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04463875
• Other study ID #: Corfu HC
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: July 2020
• Source: Corfu Headache Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: May 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Dietary Supplement:
• magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10
Supplementation per os

Locations

Country	Name	City	State
Greece	Corfu HC	Corfu

Sponsors (1)

Lead Sponsor	Collaborator
Corfu Headache Clinic

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Migraine responders	Those with =50% reduction in monthly migraine days during T3 compared to BL were considered Vivinor®-responders.	3 months
Primary	Change in monthly migraine days	Change in monthly migraine days between baseline period (BL) and the third month of treatment (T3)	3 months
Secondary	Mean intensity of migraine	Changes in mean intensity of migraine between baseline period (BL) and the third month of treatment (T3)	3 months
Secondary	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)	3 months
Secondary	Migraine Disability Assessment questionnaire (MIDAS)	Changes in scores of Migraine Disability Assessment questionnaire (MIDAS) during T3	3 months
Secondary	Headache Impact Test-6 (HIT-6)	Changes in Headache Impact Test-6 (HIT-6) during T3	3 months
Secondary	Migraine Therapy Assessment questionnaire (MTAQ)	Changes in Migraine Therapy Assessment questionnaire (MTAQ) during T3	3 months