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

NCT02901756 | Completed

• 1 other identifier: PiL-Obs-AntMIG-014
• Study Type: observational
• Target: 132
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• the number of days with migraine headache at the 3rd Month

  3rd month of supplementation

Secondary Outcomes (11)

• Number of days with migraine headache per month

  during the 1st month

• Number of days with migraine headache per month

  during the 3rd month

• Intensity of migraine headache evaluated with a 5 points Likert Scale

  during the 1st month

• Intensity of migraine headache evaluated with a 5 points Likert Scale

  during the 3rd month

• Associated symptoms evaluated with Scorecard of potential symptoms

  during the 1st month of observation, 1st, 2nd and 3rd month

Interventions

Antemig DIETARY_SUPPLEMENT

Participants were instructed to take one tablet every morning for three months.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PiLeJe: lead

Related Publications (1)

• Guilbot A, Bangratz M, Ait Abdellah S, Lucas C. A combination of coenzyme Q10, feverfew and magnesium for migraine prophylaxis: a prospective observational study. BMC Complement Altern Med. 2017 Aug 30;17(1):433. doi: 10.1186/s12906-017-1933-7.

  PMID: 28854909 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 15, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 28, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share