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Completed

NCT Number: NCT02901756

A Combination of Coenzyme Q10, Feverfew and Magnesium for Migraine Prophylaxis : a Prospective Observational 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antemig

Dietary Supplement

Participants were instructed to take one tablet every morning for three months.

Primary outcomes

  1. the number of days with migraine headache at the 3rd Month

    Time frame: 3rd month of supplementation

Secondary outcomes

  1. Number of days with migraine headache per month

    Time frame: during the 1st month

  2. Number of days with migraine headache per month

    Time frame: during the 3rd month

  3. Intensity of migraine headache evaluated with a 5 points Likert Scale

    Time frame: during the 1st month

  4. Intensity of migraine headache evaluated with a 5 points Likert Scale

    Time frame: during the 3rd month

  5. Associated symptoms evaluated with Scorecard of potential symptoms

    Time frame: during the 1st month of observation, 1st, 2nd and 3rd month

  6. Associated symptoms evaluated with Scorecard of potential symptoms

    Time frame: during the 1st month

  7. Anxiety and depression evaluated with DNS (Dopa Nora Sero) questionnaire

    Time frame: during the 3rd month

  8. Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire

    Time frame: baseline

  9. Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire

    Time frame: end of the 3rd month

  10. Compliance followed with patient logbook

    Time frame: 3 months

  11. Safety followed with side effects register

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

PiLeJe

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 15, 2016
Registry last updated
Sep 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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