neuro-complex & multi supplements for migraine prevention

Conditions: Migraine Headache; Migraine; Migraine in Adults

Summary: the goal of this prospective, monocentric, open-label, non-randomized and single arm study is to evaluate a reduction of migraine days per months (mdm) by 25% by using the combined supplementation with neuro-complex \& multi after 8 weeks of product intake on participants with diagnosis of migraine meeting the criteria of the international classification of headache disorders (ichd-3) (with or without aura). the main endpoint of this clinical trial is : the mean changes in migraine days per month (mdm) after 8 weeks of supplementation. participants will: orally consume two caps of each product (taken at the same time) daily, one in the morning and one at the lunchtime preferably during meal, for 8 weeks after a running period of 8 weeks without supplementation. intake will be initiated from the day of follow-up visit (v1) after all study procedures being performed until the day of the end-of-study visit (v2).


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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; * 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); * severe medical conditions affecting absorption and metabolism of the product, including but not restricted to chronic use of laxatives; * bariatric surgery; * 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; * 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; * specific allergies or intolerance to components of the product; * 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; * concurrent participation in another clinical study or having participated in the last 3 months: * swallowing disorders; * chronic drug and alcohol abuse; * anticoagulants (coumarin compound); * hepatic or biliar truct disorders; * active malignancy and immunosuppression therapy; * hypothyroidism; * close collaborators of investigational team, of sponsor or of study coordinator; * under guardianship or judiciable protection.

Keywords: migraine neuro-complex multi supplement headache nutrients