An observational study in Migraine, sponsored by PiLeJe. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-28.
Sponsored by PiLeJe · Observational
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.
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
This study's enrollment of 132 is close to the median of 130 across 306 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →PiLeJe is the lead sponsor of 17 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants were instructed to take one tablet every morning for three months.
the number of days with migraine headache at the 3rd Month
Time frame: 3rd month of supplementation
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
No study locations are listed for this record.
Plan to share: No
The record gives a start of Jan 2015, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
PiLeJe