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

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).

Study Overview

• Status: Recruiting
• Conditions: Migraine; Migraine Headache; Migraine in Adults
• Intervention / Treatment: Dietary supplement: Neuro-Complex and Multi

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ine Vercammen; Phone Number: 0032 15 79 27 97; Email: ine.vercammen@meclinas.com
• Study Contact Backup: Name: Elisa Debien; Phone Number: 0032 15 79 27 97; Email: elisa.debien@meclinas.com

Study Locations

• Belgium
  • Mechelen, Belgium, 2800
    • Recruiting
    • Meclinas
    • Contact: Ine Vercammen; Phone Number: 0032 15 79 27 97; Email: ine.vercammen@meclinas.com
    • Contact: Elisa Debien; Phone Number: 0032 15 79 27 97; Email: elisa.debien@meclinas.com
    • Principal Investigator: Merel Brems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supplementation Arm - Neuro-Complex and Multi Combination

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). Participants will take 1 cap of each product simultaneously twice a day directly in their mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of migraine days per month (MDM) by 25% by using the combined supplementation with Neuro-Complex & Multi after 8 weeks of product intake	Mean change of migraine days per month (MDM)	Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effect on migraine intensity/severity after 8 weeks of product intake	Mean change in migraine intensity/severity measured using a numerical rating scale after 8 weeks of product intake	Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
Evaluate the effect on migraine duration after 8 weeks of product intake	Mean change in migraine duration defined as start date and end date of each migraine episode captured by the patient	Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
Evaluate the effect on symptoms associated with migraine after 8 weeks of product intake	Mean change in symptoms measured using a 5-likert scale	Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
Evaluate the effect on quality of life (QoL) after 8 weeks of product intake	Mean change in QoL assessed using self-reported questionnaire (SF-36)	Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
Evaluate the effect on number of responders to the supplementation after 8 weeks of product intake	Proportion of responders defined as patients with ≥50% reduction in MDM	Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
• Evaluate the effect on reduction in the use of acute medication for migraine after 8 weeks of product intake	Mean change in days of use of acute medication against migraine	Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
Evaluate the effect on patient tolerance after 8 weeks of product intake	Mean change in number of Adverse events (AE)	Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
Evaluate the effect on migraine days per month (MDM) after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)	Mean change of migraine days per month (MDM)	Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
Evaluate the effect on migraine intensity/severity after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)	Mean change in migraine intensity measured using a numerical rating scale	Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
Evaluate the effect on migraine duration after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)	Mean change in migraine duration defined as start date and end date of each migraine episode captured by the patient	Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
Evaluate the effect on symptoms associated with migraine after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)	Mean change in symptoms measured using a 5-likert scale	Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
Evaluate the effect on quality of life (QoL) after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)	Mean change in QoL assessed using self-reported questionnaire (SF-36)	Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
Evaluate the effect on number of responders to the supplementation after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)	Proportion of responders defined as patients with ≥50% reduction in MDM	Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
Evaluate the effect on reduction in the use of acute medication for migraine after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)	Mean change in days of use of acute medication against migraine	Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
Evaluate the effect on patient tolerance after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)	Mean change in number of Adverse events (AE)	Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
Compare the effect on migraine days per month (MDM) between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)	Mean change of migraine days per month (MDM)	Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
Compare the effect on migraine intensity/severity between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)	Mean change in migraine intensity measured using a numerical rating scale	Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
Compare the effect on migraine duration between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)	Mean change in migraine duration defined as start date and end date of each migraine episode captured by the patient	Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
Compare the effect on symptoms associated with migraine between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)	Mean change in symptoms measured using a 5-likert scale	Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
Compare the effect on quality of life (QoL) between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)	Mean change in QoL assessed using self reported questionnaire (SF-36)	Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
Compare the effect on number of responders to the supplementation between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)	Proportion of responders defined as patients with ≥50% reduction in MDM	Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
Compare the effect on reduction in the use of acute medication for migraine between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)	Mean change in days of use of acute medication against migraine	Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
Compare the effect on patient tolerance between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)	Mean change in number of Adverse events (AE)	Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)

Collaborators and Investigators

• Sponsor: Benfida, a department of Handi-Move
• Collaborators: Artialis

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 16, 2025

Study Registration Dates

• First Submitted: May 19, 2025
• First Submitted That Met QC Criteria: June 3, 2025
• First Posted (Actual): June 11, 2025

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Migraine; headache; Supplement; nutrients; Neuro-Complex; Multi
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No