Neuro-Complex & Multi Supplements for Migraine Prevention

Prior treatment

• Medication overuse for headache defined as acute headache medication \>10-15 days per month depending on the half-life of the medication (left to PI discretion);
• Bariatric surgery;
• Concurrent participation in another clinical study or having participated in the last 3 months:
• Chronic drug and alcohol abuse;

Other illness

• Other primary head pain disorders such as but not restricted to tension-type headache, cluster headache, fibromyalgia;
• Secondary head pain due to trauma, injury, infections;
• Severe medical conditions affecting absorption and metabolism of the product, including but not restricted to chronic use of laxatives;
• Severe psychiatric conditions that could interfere with diary compliance or assessment of the product (e.g., severe depression or cognitive impairments) left to investigator discretion;
• Specific allergies or intolerance to components of the product;
• Swallowing disorders;
• Hepatic or biliar truct disorders;
• Active malignancy and immunosuppression therapy;

Other

• Use of other dietary supplements that could potentially affect migraines, unless willing to discontinue them before the study begins (wash out period of 3 months);
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
• Women of childbearing potential without medically effective form of contraception unless they can confirm they've had bilateral tubal ligation or that their male partner has had a vasectomy;
• Recent migraine interventions: Such as Botox injections (except if considered as a stable treatment, i.e. not the first injection), nerve blocks, or other invasive treatments in the last 6 months;
• Anticoagulants (coumarin compound);
• Hypothyroidism;
• Close collaborators of investigational team, of sponsor or of study coordinator;
• Under guardianship or judiciable protection.

• Male or female between 18 and 75 years;
• Diagnosis of migraine meeting the criteria of the International Classification of Headache Disorders (ICHD-3) (with or without aura)
  • At least 5 attacks fulfilling the criteria below
  • Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
  • Headache has at least two of the following characteristics
  • unilateral location
  • pulsating quality
  • moderate or severe pain intensity
  • aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
  • During headache at least one of the following:
  • nausea and/or vomiting
  • photophobia and phonophobia
  • Not attributed to another disorder
• Migraine frequency of at least 6 headache days per month during the last 3 months;
• Stable body mass index (BMI) between 18.5-35.0;
• Stable medication use with no significant changes in prophylactic or acute migraine treatments in the past 3 months, and willingness to maintain or reduce (if not needed) this throughout the study period;
• Willingness and ability to complete an ediary (mobile app or web based) and to follow the instruction of the study;
• Having signed an informed consent.