Effectiveness of an Orally Administered and Combined Neuro-Complex & Multi Supplements in the Prevention of Migraine in Adult
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).
• 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.