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

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ClinicalTrials.gov Identifier: NCT02901756
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Pileje

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.

Condition or disease Intervention/treatment
Migraine Dietary Supplement: Antemig

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.


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Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine


Intervention Details:
  • Dietary Supplement: Antemig
    Participants were instructed to take one tablet every morning for three months.


Primary Outcome Measures :
  1. the number of days with migraine headache at the 3rd Month [ Time Frame: 3rd month of supplementation ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pileje
ClinicalTrials.gov Identifier: NCT02901756     History of Changes
Other Study ID Numbers: PiL-Obs-AntMIG-014
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases