A Combination of Coenzyme Q10, Feverfew and Magnesium for Migraine Prophylaxis : a Prospective Observational Study
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| ClinicalTrials.gov Identifier: NCT02901756 |
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Recruitment Status :
Completed
First Posted : September 15, 2016
Last Update Posted : September 28, 2016
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| Condition or disease | Intervention/treatment |
|---|---|
| Migraine | Dietary Supplement: Antemig |
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.
| 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 |
- Dietary Supplement: Antemig
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 ]
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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 |
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
| Responsible Party: | PiLeJe |
| ClinicalTrials.gov Identifier: | NCT02901756 |
| 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 |
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Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |