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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIETARY_SUPPLEMENT

Neuro-Complex and Multi

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)

Meclinas
Mechelen, Belgium