NCT07015411 Neuro-Complex & Multi Supplements for Migraine Prevention
| NCT ID | NCT07015411 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Benfida, a department of Handi-Move |
| Condition | Migraine Headache |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-05-15 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07015411 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Migraine Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07015411 currently recruiting?
Yes, NCT07015411 is actively recruiting participants. Contact the research team at ine.vercammen@meclinas.com for enrollment information.
Where is the NCT07015411 trial being conducted?
This trial is being conducted at Mechelen, Belgium.
Who is sponsoring the NCT07015411 clinical trial?
NCT07015411 is sponsored by Benfida, a department of Handi-Move. The trial plans to enroll 120 participants.
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