💬In plain words
What the trial is, and whether it could suit you
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 th
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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