migraine with and without aura G43 G43
Conditions
Interventions
Group 1: Migravent®: 2 capsules with meals in the morning and 2 capsules in the evening.
Substances: 400 mg riboflavin (Vitamin B2), 600 mg magnesium, 150 mg coenzyme Q10 per 4 capsules. In addition,
Sponsors
Weber & Weber GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with migraine with and without aura diagnosed according to IHS-criteria ICHD-II 1.1 und 1.2. 2. Migraine was present and diagnosed at least one year before study entry. 3. The age at onset of migraine should be less than 50 years. 4. At least 3 migraine attacks per month in the last 3 months prior to study entry as well as in the run-in period. The duration of untreated attacks must not be less than 4 hours and not more than 72 hours. 5. The patient is able to distinguish between migraine and tension type headache. 6. The age of the patient is between 18 and 65 years. 7. The patient has internet access and is able to fill out the online diary. 8. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Less than 3 migraine attacks in the run-in period. 2. Use of migraine prevention (drugs, nutritional supplements or psychotherapy) during the last 3 months prior to study entry and throughout the study. 3. Use of antipsychotic or antidepressant medication during the last 3 months prior to study entry and throughout the study. 4. Chronic use of pain medication. 5. Failure to respond to more than 2 different prophylactic agents. 6. Patients resistant to all acute migraine drugs prescribed optimally. 7. Alcohol or drug abuse. 8. Patients with more than 10 days per month of migraine. A migraine day is a day with at least 4 hours of untreated headache and accompanying symptoms fulfilling the criteria of migraine. 9. Patients with more than 10 days per month of non-migraine headache. 10. History of hypersensitivity to the investigational nutritional supplement or to its ingredients. 11. Systemic, severe as well as history of uncontrolled chronic disease or a concurrent clinically significant illness, or medical condition, which in the investigator’s opinion, would contraindicate study participation or compliance with protocol mandated procedures. 12. Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product or nutritional product within 30 days prior to written informed consent for this trial. 13. Patients unable to follow study procedures and unable to use an internet based diary.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined as the number of migraine days per 4 weeks in the last month of the 3 months-treatment. The patients’ number of migraine days per 4 weeks will be determined during the last month of the 3-months-treatment period as well as during the 1 month run-in period (no treatment) for baseline adjustment. Data collection and documentation for the assessment of the primary study endpoint will be performed by the patient via internet access by filling out an online diary daily during the 1 month run-in and the 3 months treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Duration of migraine attacks - Maximal intensity of migraine pain - Number of migraine attacks - Number of patients with at least 50% reduction in migraine attacks compared to the run-in period - Number of patients with at least 50% reduction in migraine days compared to the run-in period - Number of patients with a reduction in migraine attacks compared to the run-in period - Number of patients with reduction in migraine days compared to the run-in period - Number of days with acute pain medication - Type and amount of pain medication - Number of doctor visits due to migraine - Number of days in hospital (overnight) due to migraine - costs of migraine treatment - Number of days unable to work (household / employment / school) - Burden of disease measured by HIT-6 - Screening for depression or anxiety using HADS - Subjective evaluation of efficacy by patient - Subjective evaluation of tolerability by patient - Adverse events Data collection and documentation for the assessment of the secondary study endpoints will be performed 1) by the investigating physician using a paper based CRF at screening, after the run-in period and at the end of the treatment (end of trial). In addition the HIT-6 and HADS questionnaire will be filled out before randomization and after the end of the trial. 2) by the patient via internet access by filling out an online diary daily during the 1 month run-in and the 3 months treatment period. | — |
Countries
Germany
Contacts
Public ContactUlrich Danesch
Weber & Weber GmbH & Co. KG
Outcome results
None listed