Clinical trial NCT02901756: A Combination of Coenzyme Q10, Feverfew and Magnesium for Migraine Prophylaxis : a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Lead sponsor: PiLeJe
Sponsor class: INDUSTRY
First posted: 2016-09-15
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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)

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: the number of days with migraine headache at the 3rd Month
timeFrame: 3rd month of supplementation
Secondary outcomes:
measure: Number of days with migraine headache per month
timeFrame: during the 1st month
measure: Number of days with migraine headache per month
timeFrame: during the 3rd month
measure: Intensity of migraine headache evaluated with a 5 points Likert Scale
timeFrame: during the 1st month
measure: Intensity of migraine headache evaluated with a 5 points Likert Scale
timeFrame: during the 3rd month
measure: Associated symptoms evaluated with Scorecard of potential symptoms
timeFrame: during the 1st month of observation, 1st, 2nd and 3rd month
measure: Associated symptoms evaluated with Scorecard of potential symptoms
timeFrame: during the 1st month
measure: Anxiety and depression evaluated with DNS (Dopa Nora Sero) questionnaire
timeFrame: during the 3rd month
measure: Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire
timeFrame: baseline
measure: Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire
timeFrame: end of the 3rd month
measure: Compliance followed with patient logbook
timeFrame: 3 months
measure: Safety followed with side effects register
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.