Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07015411

Neuro-Complex & Multi Supplements for Migraine Prevention

Led by Benfida, a department of Handi-Move · Updated on 2025-06-11

120

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

B

Benfida, a department of Handi-Move

Lead Sponsor

A

Artialis

Collaborating Sponsor

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

Neuro-Complex & Multi Supplements for Migraine Prevention

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female between 18 and 75 years
  • Diagnosis of migraine according to the International Classification of Headache Disorders (ICHD-3), with or without aura
  • At least 5 migraine attacks lasting 4 to 72 hours (untreated or unsuccessfully treated)
  • Headache has at least two of the following: unilateral location, pulsating quality, moderate or severe pain, or worsened by routine physical activity
  • During headache, at least one of the following: nausea/vomiting or sensitivity to light/sound
  • Migraine frequency of at least 6 headache days per month during the last 3 months
  • Stable body mass index (BMI) between 18.5 and 35.0
  • Stable medication use for migraine with no significant changes in the past 3 months and willingness to maintain or reduce treatment during the study
  • Willingness and ability to complete an electronic diary and follow study instructions
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Other primary head pain disorders such as tension-type headache, cluster headache, or fibromyalgia
  • Secondary head pain due to trauma, injury, or infections
  • Medication overuse for headache (>10-15 days per month depending on medication half-life)
  • Severe medical conditions affecting absorption and metabolism of the product, including chronic laxative use
  • History of bariatric surgery
  • Severe psychiatric conditions affecting compliance or assessment (e.g., severe depression or cognitive impairments)
  • Use of other dietary supplements affecting migraines unless willing to discontinue before the study (3-month washout)
  • Pregnant, breastfeeding, or planning pregnancy during study
  • Women of childbearing potential without effective contraception unless surgically sterile
  • Allergies or intolerance to product components
  • Recent migraine interventions such as Botox injections (unless stable), nerve blocks, or invasive treatments within last 6 months
  • Participation in another clinical study within last 3 months
  • Swallowing disorders
  • Chronic drug or alcohol abuse
  • Use of anticoagulants (coumarin compounds)
  • Hepatic or biliary tract disorders
  • Active malignancy or immunosuppression therapy
  • Hypothyroidism
  • Close collaborators of the investigational team or sponsor
  • Under guardianship or judicial protection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Meclinas

Mechelen, Belgium, 2800

Actively Recruiting

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Research Team

I

Ine Vercammen

CONTACT

E

Elisa Debien

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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