Neuro-Complex & Multi Supplements for Migraine Prevention
Effectiveness of an Orally Administered and Combined Neuro-Complex & Multi Supplements in the Prevention of Migraine in Adult
Benfida, a department of Handi-Move
120 participants
May 15, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria18
- 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 Criteria20
- 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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Interventions
Participants will orally consume 2 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). Participants will take 1 cap of each product simultaneously twice a day directly in their mouth.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07015411