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

July 6, 2020 updated by: KONSTANTINOS SPINGOS, Corfu Headache Clinic

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Corfu, Greece, 49100
        • Corfu HC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in monthly migraine days
Time Frame: 3 months
Change in monthly migraine days between baseline period (BL) and the third month of treatment (T3)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean intensity of migraine
Time Frame: 3 months
Changes in mean intensity of migraine between baseline period (BL) and the third month of treatment (T3)
3 months
days with use of acute migraine medications
Time Frame: 3 months
Changes in days with use of acute migraine medications between baseline period (BL) and the third month of treatment (T3)
3 months
Migraine Disability Assessment questionnaire (MIDAS)
Time Frame: 3 months
Changes in scores of Migraine Disability Assessment questionnaire (MIDAS) during T3
3 months
Headache Impact Test-6 (HIT-6)
Time Frame: 3 months
Changes in Headache Impact Test-6 (HIT-6) during T3
3 months
Migraine Therapy Assessment questionnaire (MTAQ)
Time Frame: 3 months
Changes in Migraine Therapy Assessment questionnaire (MTAQ) during T3
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine responders
Time Frame: 3 months
Those with ≥50% reduction in monthly migraine days during T3 compared to BL were considered Vivinor®-responders.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corfu Headache Clinic

Investigators

  • Principal Investigator: Michail Michail, MD, MSc, PhD, Mediterraneo Hospital, Glyfada, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

July 6, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Corfu HC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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