Neuro-Complex & Multi Supplements for Migraine Prevention

Launched by BENFIDA, A DEPARTMENT OF HANDI-MOVE · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a combination of two dietary supplements, called Neuro-Complex and Multi, can help reduce the number of migraine days experienced by adults. The goal is to see if participants can have at least a 25% reduction in their monthly migraine days after taking these supplements for eight weeks. To participate, individuals must be between 18 and 75 years old and have a diagnosed history of migraines that meet specific criteria, including experiencing at least six migraine days per month.

Participants in the trial will take two capsules of each supplement daily—one in the morning and one at lunchtime—preferably during meals. They will start this supplementation after an initial eight-week period without any supplements. Throughout the study, participants will be asked to keep track of their migraines using an electronic diary to help researchers understand the impact of the supplements. It’s important to note that individuals with certain medical conditions or who are taking specific medications may not be eligible to join the study.

Gender

ALL

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.