Neuro-Complex & Multi Supplements for Migraine Prevention

NCT07015411 | Recruiting

• 1 other identifier: 001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Migraine Headache; Migraine; Migraine in Adults

Keywords

Migraine; Neuro-Complex; Multi; Supplement; headache; nutrients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Evaluate the effect on migraine intensity/severity 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

  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

  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

  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

  Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)

Study Arms (1)

Supplementation Arm - Neuro-Complex and Multi Combination

EXPERIMENTAL

Dietary Supplement: Neuro-Complex and Multi

Interventions

Neuro-Complex and Multi DIETARY_SUPPLEMENT

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.

Supplementation Arm - Neuro-Complex and Multi Combination

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Benfida, a department of Handi-Move: lead
• Artialis: collaborator

Study Sites (1)

Meclinas

Mechelen, 2800, Belgium

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ine Vercammen

CONTACT

0032 15 79 27 97; ine.vercammen@meclinas.com

Elisa Debien

CONTACT

0032 15 79 27 97; elisa.debien@meclinas.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 11, 2025
• Study Start: May 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 16, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

BE (1)