NCT04463875

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

July 6, 2020

Last Update Submit

July 6, 2020

Conditions

Migraine

Keywords

episodic migrainesupplementVivinormagnesiumvitamin B2andrographis paniculatacoenzyme Q10

Outcome Measures

Primary Outcomes (1)

  • Change in monthly migraine days

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

    3 months

Secondary Outcomes (5)

  • Mean intensity of migraine

    3 months

  • days with use of acute migraine medications

    3 months

  • Migraine Disability Assessment questionnaire (MIDAS)

    3 months

  • Headache Impact Test-6 (HIT-6)

    3 months

  • Migraine Therapy Assessment questionnaire (MTAQ)

    3 months

Other Outcomes (1)

  • Migraine responders

    3 months

Interventions

magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10DIETARY_SUPPLEMENT

Supplementation per os

Also known as: Vivinor

Eligibility Criteria

Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corfu HC

Corfu, 49100, Greece

Location

Related 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.

    PMID: 22529203BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

MagnesiumRiboflavinfeverfew extractAndrographis paniculata extractcoenzyme Q10

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetalsFlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological Factors

Study Officials

  • Michail Michail, MD, MSc, PhD

    Mediterraneo Hospital, Glyfada, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 9, 2020

Study Start

April 1, 2018

Primary Completion

April 30, 2020

Study Completion

May 31, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)