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

Migraine Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901756
• Other study ID #: PiL-Obs-AntMIG-014
• Status: Completed
• Phase: N/A
• First received: August 24, 2016
• Last updated: September 27, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: Pileje
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pileje

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of days with migraine headache at the 3rd Month		3rd month of supplementation	Yes
Secondary	Number of days with migraine headache per month		during the 1st month	Yes
Secondary	Number of days with migraine headache per month		during the 3rd month	Yes
Secondary	Intensity of migraine headache evaluated with a 5 points Likert Scale		during the 1st month	Yes
Secondary	Intensity of migraine headache evaluated with a 5 points Likert Scale		during the 3rd month	Yes
Secondary	Associated symptoms evaluated with Scorecard of potential symptoms		during the 1st month of observation, 1st, 2nd and 3rd month	Yes
Secondary	Associated symptoms evaluated with Scorecard of potential symptoms		during the 1st month	Yes
Secondary	Anxiety and depression evaluated with DNS (Dopa Nora Sero) questionnaire		during the 3rd month	Yes
Secondary	Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire		baseline	Yes
Secondary	Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire		end of the 3rd month	Yes
Secondary	Compliance followed with patient logbook		3 months	Yes
Secondary	Safety followed with side effects register		3 months	Yes