[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594128":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":29,"responsibleParty":49,"collaborators":51,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Benfida, a department of Handi-Move","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Supplementation Arm - Neuro-Complex and Multi Combination","EXPERIMENTAL",null,[13],"Dietary Supplement: Neuro-Complex and Multi",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"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).\n\nParticipants will take 1 cap of each product simultaneously twice a day directly in their mouth.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Ine Vercammen","CONTACT","0032 15 79 27 97","ine.vercammen@meclinas.com",{"name":27,"role":23,"phone":24,"phoneExt":11,"email":28},"Elisa Debien","elisa.debien@meclinas.com",[30],{"facility":31,"status":32,"city":33,"state":11,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Meclinas","RECRUITING","Mechelen","2800","Belgium","BE",{"type":38,"coordinates":39},"Point",[40,41],4.47762,51.02574,{"lat":41,"lon":40},[44,45,46],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},{"name":27,"role":23,"phone":24,"phoneExt":11,"email":28},{"name":47,"role":48,"phone":11,"phoneExt":11,"email":11},"Merel Brems","PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[52],{"name":53,"class":6},"Artialis","100594128","neuro-complex--multi-supplements-for-migraine-prevention-100594128",false,"NCT07015411","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","NeuroCare","Inclusion Criteria:\n\n* Male or female between 18 and 75 years;\n* Diagnosis of migraine meeting the criteria of the International Classification of Headache Disorders (ICHD-3) (with or without aura)\n\n  * At least 5 attacks fulfilling the criteria below\n  * Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)\n  * Headache has at least two of the following characteristics\n\n    * unilateral location\n    * pulsating quality\n    * moderate or severe pain intensity\n    * aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)\n  * During headache at least one of the following:\n\n    * nausea and\u002For vomiting\n    * photophobia and phonophobia\n  * Not attributed to another disorder\n* Migraine frequency of at least 6 headache days per month during the last 3 months;\n* Stable body mass index (BMI) between 18.5-35.0;\n* 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;\n* Willingness and ability to complete an ediary (mobile app or web based) and to follow the instruction of the study;\n* Having signed an informed consent.\n\nExclusion Criteria:\n\n* Other primary head pain disorders such as but not restricted to tension-type headache, cluster headache, fibromyalgia;\n* Secondary head pain due to trauma, injury, infections;\n* 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);\n* Severe medical conditions affecting absorption and metabolism of the product, including but not restricted to chronic use of laxatives;\n* Bariatric surgery;\n* 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;\n* 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);\n* Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;\n* 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;\n* Specific allergies or intolerance to components of the product;\n* 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;\n* Concurrent participation in another clinical study or having participated in the last 3 months:\n* Swallowing disorders;\n* Chronic drug and alcohol abuse;\n* Anticoagulants (coumarin compound);\n* Hepatic or biliar truct disorders;\n* Active malignancy and immunosuppression therapy;\n* Hypothyroidism;\n* Close collaborators of investigational team, of sponsor or of study coordinator;\n* Under guardianship or judiciable protection.","ALL","18 Years","75 Years",{"count":66,"type":67},120,"ESTIMATED","INTERVENTIONAL",[70],"NA","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).\n\nThe main endpoint of this clinical trial is :\n\nThe mean changes in migraine days per month (MDM) after 8 weeks of supplementation.\n\nParticipants will:\n\nOrally 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).",[73,74,75],"Migraine Headache","Migraine","Migraine in Adults",[74,77,78,79,80,81],"Neuro-Complex","Multi","Supplement","headache","nutrients","2025-06-03",{"date":84,"type":85},"2025-06-11","ACTUAL",{"date":87,"type":85},"2025-05-15",{"date":89,"type":67},"2025-12-16",{"name":5,"class":6},1]