Migraine Clinical Trial
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.
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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Observational Model: Case-Only, Time Perspective: Prospective
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|---|---|---|---|
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