MigraineNCT04463875
Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis
An observational study of Migraine, run by Corfu Headache Clinic at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10
- How many people
- 113 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2018to 31 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Migraine
- Being tested
- magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10
- Keywords
- episodic migraine, supplement, Vivinor, magnesium, vitamin B2, andrographis paniculata, coenzyme Q10
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10Dietary supplement
Also called Vivinor
Supplementation per os
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in monthly migraine days
Change in monthly migraine days between baseline period (BL) and the third month of treatment (T3)
Measured: 3 months
Secondary outcomes (5)
Mean intensity of migraine
Changes in mean intensity of migraine between baseline period (BL) and the third month of treatment (T3)
Measured: 3 months
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)
Measured: 3 months
Migraine Disability Assessment questionnaire (MIDAS)
Changes in scores of Migraine Disability Assessment questionnaire (MIDAS) during T3
Measured: 3 months
Headache Impact Test-6 (HIT-6)
Changes in Headache Impact Test-6 (HIT-6) during T3
Measured: 3 months
Migraine Therapy Assessment questionnaire (MTAQ)
Changes in Migraine Therapy Assessment questionnaire (MTAQ) during T3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Apr 2018
- Primary completion30 Apr 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corfu Headache Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KONSTANTINOS SPINGOS, Corfu Headache Clinic
- Investigators
- Michail Michail, MD, MSc, PhD, Principal investigator, Mediterraneo Hospital, Glyfada, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463875
- Sponsor's protocol ID
- Corfu HC
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22529203
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04463875
- Acronym / sponsor ID
- Corfu HC
- Conditions
- Migraine
- Keywords
- episodic migraine, supplement, Vivinor, magnesium, vitamin B2, andrographis paniculata, coenzyme Q10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Corfu Headache ClinicUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10Also: VivinorSupplementation per os | Dietary supplement | – |
Primary outcome
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)
5 secondary outcomes
Mean intensity of migraine
Time frame: 3 months
days with use of acute migraine medications
Time frame: 3 months
Migraine Disability Assessment questionnaire (MIDAS)
Time frame: 3 months
Headache Impact Test-6 (HIT-6)
Time frame: 3 months
Migraine Therapy Assessment questionnaire (MTAQ)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Background: PubMed 22529203Holland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michail Michail, MD, MSc, PhD principal investigator
Mediterraneo Hospital, Glyfada, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Corfu Headache Clinic at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in monthly migraine days (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04463875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.