Neuro-Complex & Multi Supplements for Migraine Prevention (NeuroCare)

Benfida, a department of Handi-Move

Status: Enrolling

Conditions: Migraine in Adults; Migraine Headache; Migraine

Treatments: Dietary Supplement: Neuro-Complex and Multi

Study type: Interventional

Funder types: Industry

Identifiers

NCT07015411

001

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Supplementation Arm - Neuro-Complex and Multi Combination

Experimental group

Treatment:

Dietary Supplement: Neuro-Complex and Multi