MigraineNCT02901756
A Combination of Coenzyme Q10, Feverfew and Magnesium for Migraine Prophylaxis : a Prospective Observational Study
An observational study of Migraine, run by PiLeJe.
Trial summary
Adult patients suffering from migraine according to the criteria of the International Headache Society were enrolled by general practitioners (≥2 migraine attacks during previous month; exclusion of chronic migraine and medication overuse) and after a one-month baseline phase, supplemented with one tablet of 100 mg… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Antemig
- Type of treatment
- Pill or oral medicine
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients were recruited by general practitioners (GPs). Patients had to suffer from migraine with or without aura diagnosed according to the criteria of the International Classification of Headaches Disorders III (ICHD III 1.1 and 1.2)
Who may be able to join
- to suffer from migraine with or without aura diagnosed according to the criteria of the International Classification of Headaches Disorders III (ICHD III 1.1 and 1.2)
- to suffer from migraine for more than one year
- to be less than 50 years old at migraine onset
- to have had at least two migraine attacks during the month before recruitment
Who cannot join
- migraine with aura with motor symptoms (hemiplegic migraine)
- more than 15 migraine attacks per month
- abuse of painkillers defined as the use of paracetamol, aspirin and non-steroid anti-inflammatory drugs for more than 15 days per month over the last three months or the use of triptans, opioids and ergot-type medications for more than 10 days per month during the last three months
- prophylactic treatment taken for less than 3 months
About this study
Adult patients suffering from migraine according to the criteria of the International Headache Society were enrolled by general practitioners (≥2 migraine attacks during previous month; exclusion of chronic migraine and medication overuse) and after a one-month baseline phase, supplemented with one tablet of 100 mg feverfew, 100 mg coenzyme Q10 and 112.5 mg magnesium per day for 3 months.
Read the detailed description
Three visits were planned: V1, V2 on Day 30 (± 10) and V3 on Day 120 (± 10). On V1, after checking the inclusion criteria and receiving informed consent, GPs collected demographic data, medical and migraine history and information on migraine attacks, associated symptoms and rescue medications via an electronic case report form. V1 was followed by a one-month observation period (baseline phase) during which migraine treatment of patients was not modified. From V1 till the end of the study, all patients kept an electronic diary in which they reported migraine characteristics (number of days with migraine headache, intensity, associated symptoms and concomitant medications). On the second visit (V2; Day 30 ± 10), eligibility of patients was verified: patients with less than 2 or more than 15 migraine attacks during baseline phase and patients unwilling to be supplemented with the combination were excluded from the study. Eligible patients were advised to start supplementation. On V3 (Day 120 ± 10), information provided in patient's diary and compliance with supplementation were checked.
The day before V2 and V3, patients had to complete the French migraine-related quality of life questionnaire (Qualité de Vie et Migraine [QVM]) and the Hospital Anxiety and Depression Scale (HADS).
The study was conducted in accordance with articles L.1121-1 and R1121-2 of the French public health code defining non interventional studies; all the acts were practised and products used in a usual way without any additional or unusual procedure of diagnosis or surveillance.
- Conditions
- Migraine
- Being tested
- Antemig
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntemigDietary supplement
Participants were instructed to take one tablet every morning for three months.
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of days with migraine headache at the 3rd Month
Measured: 3rd month of supplementation
Secondary outcomes (11)
Number of days with migraine headache per month
Measured: during the 1st month
Number of days with migraine headache per month
Measured: during the 3rd month
Intensity of migraine headache evaluated with a 5 points Likert Scale
Measured: during the 1st month
Intensity of migraine headache evaluated with a 5 points Likert Scale
Measured: during the 3rd month
Associated symptoms evaluated with Scorecard of potential symptoms
Measured: during the 1st month of observation, 1st, 2nd and 3rd month
Associated symptoms evaluated with Scorecard of potential symptoms
Measured: during the 1st month
Anxiety and depression evaluated with DNS (Dopa Nora Sero) questionnaire
Measured: during the 3rd month
Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire
Measured: baseline
Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire
Measured: end of the 3rd month
Compliance followed with patient logbook
Measured: 3 months
Safety followed with side effects register
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 posted15 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901756
- Sponsor's protocol ID
- PiL-Obs-AntMIG-014
- Status last verified
- Sep 2016
- First submitted
- 24 Aug 2016
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Guilbot A, Bangratz M, Ait Abdellah S, Lucas C. A combination of coenzyme Q10, feverfew and magnesium for migraine prophylaxis: a prospective observational study. BMC Complement Altern Med. 2017 Aug 30;17(1):433. doi: 10.1186/s12906-017-1933-7.
PubMed 28854909
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of Coenzyme Q10, Feverfew and Magnesium for Migraine Prophylaxis : a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02901756
- Acronym / sponsor ID
- PiL-Obs-AntMIG-014
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Sep 2016 (estimated)
- 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.
Adult patients suffering from migraine according to the criteria of the International Headache Society were enrolled by general practitioners (≥2 migraine attacks during previous month; exclusion of chronic migraine and medication overuse) and after a one-month baseline phase, supplemented with one tablet of 100 mg feverfew, 100 mg coenzyme Q10 and 112.5 mg magnesium per day for 3 months.
Detailed description
Three visits were planned: V1, V2 on Day 30 (± 10) and V3 on Day 120 (± 10). On V1, after checking the inclusion criteria and receiving informed consent, GPs collected demographic data, medical and migraine history and information on migraine attacks, associated symptoms and rescue medications via an electronic case report form. V1 was followed by a one-month observation period (baseline phase) during which migraine treatment of patients was not modified. From V1 till the end of the study, all patients kept an electronic diary in which they reported migraine characteristics (number of days with migraine headache, intensity, associated symptoms and concomitant medications). On the second visit (V2; Day 30 ± 10), eligibility of patients was verified: patients with less than 2 or more than 15 migraine attacks during baseline phase and patients unwilling to be supplemented with the combination were excluded from the study. Eligible patients were advised to start supplementation. On V3 (Day 120 ± 10), information provided in patient's diary and compliance with supplementation were checked.
The day before V2 and V3, patients had to complete the French migraine-related quality of life questionnaire (Qualité de Vie et Migraine [QVM]) and the Hospital Anxiety and Depression Scale (HADS).
The study was conducted in accordance with articles L.1121-1 and R1121-2 of the French public health code defining non interventional studies; all the acts were practised and products used in a usual way without any additional or unusual procedure of diagnosis or surveillance.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients were recruited by general practitioners (GPs). Patients had to suffer from migraine with or without aura diagnosed according to the criteria of the International Classification of Headaches Disorders III (ICHD III 1.1 and 1.2)
Key inclusion criteria (4 listed)
- to suffer from migraine with or without aura diagnosed according to the criteria of the International Classification of Headaches Disorders III (ICHD III 1.1 and 1.2)
- to suffer from migraine for more than one year
- to be less than 50 years old at migraine onset
- to have had at least two migraine attacks during the month before recruitment
Key exclusion criteria (4 listed)
- migraine with aura with motor symptoms (hemiplegic migraine)
- more than 15 migraine attacks per month
- abuse of painkillers defined as the use of paracetamol, aspirin and non-steroid anti-inflammatory drugs for more than 15 days per month over the last three months or the use of triptans, opioids and ergot-type medications for more than 10 days per month during the last three months
- prophylactic treatment taken for less than 3 months
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 |
|---|---|---|
| AntemigParticipants were instructed to take one tablet every morning for three months. | Dietary supplement | – |
Primary outcome
the number of days with migraine headache at the 3rd Month
Time frame: 3rd month of supplementation
11 secondary outcomes
Number of days with migraine headache per month
Time frame: during the 1st month
Number of days with migraine headache per month
Time frame: during the 3rd month
Intensity of migraine headache evaluated with a 5 points Likert Scale
Time frame: during the 1st month
Intensity of migraine headache evaluated with a 5 points Likert Scale
Time frame: during the 3rd month
Associated symptoms evaluated with Scorecard of potential symptoms
Time frame: during the 1st month of observation, 1st, 2nd and 3rd month
Associated symptoms evaluated with Scorecard of potential symptoms
Time frame: during the 1st month
Anxiety and depression evaluated with DNS (Dopa Nora Sero) questionnaire
Time frame: during the 3rd month
Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire
Time frame: baseline
Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire
Time frame: end of the 3rd month
Compliance followed with patient logbook
Time frame: 3 months
Safety followed with side effects register
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 28 Sep 2016.
- Derived from this study: PubMed 28854909Guilbot A, Bangratz M, Ait Abdellah S, Lucas C. A combination of coenzyme Q10, feverfew and magnesium for migraine prophylaxis: a prospective observational study. BMC Complement Altern Med. 2017 Aug 30;17(1):433. doi: 10.1186/s12906-017-1933-7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by PiLeJe.
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 4 inclusion and 4 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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
the number of days with migraine headache at the 3rd Month (time frame: 3rd month of supplementation). 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 NCT02901756, 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 28 Sep 2016.