[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Benfida, a department of Handi-Move\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"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":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"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).",[28,29,30],"Migraine Headache","Migraine","Migraine in Adults",[29,32,33,34,35,36],"Neuro-Complex","Multi","Supplement","headache","nutrients","RECRUITING","2025-06-03",{"date":40,"type":41},"2025-06-11","ACTUAL",{"date":43,"type":41},"2025-05-15",{"date":45,"type":22},"2025-12-16",{"name":47,"class":48},"Benfida, a department of Handi-Move","INDUSTRY",""]