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Migraine HeadacheNeuroCareNCT07015411

Neuro-Complex & Multi Supplements for Migraine Prevention

A study testing Neuro-Complex and Multi in people with Migraine Headache and Migraine, run by Benfida, a department of Handi-Move at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine Headache, Migraine, Migraine in Adults
What is being tested?
Neuro-Complex and Multi
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteBelgium
Study dates
15 May 2025to 16 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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;
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  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium1 site, 1 recruiting
  • Meclinas

    Mechelen, 2800

    Ine Vercammen, 0032 15 79 27 97, ine.vercammen@meclinas.com

    Elisa Debien, 0032 15 79 27 97, elisa.debien@meclinas.com

    Recruiting

Other trials in Belgium

About this study

Official title: 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 :

Read more

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).

Being tested
Neuro-Complex and Multi
Keywords
Migraine, Neuro-Complex, Multi, Supplement, headache, nutrients
Medical subject headings
Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuro-Complex and MultiDietary 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.

Study groups in NCT07015411
Study groupRoleWhat they receive
Supplementation Arm - Neuro-Complex and Multi CombinationExperimentalNot described
Receives: Dietary Supplement: Neuro-Complex and Multi

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (23)
  1. 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

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

  2. 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

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

  3. Evaluate the effect on symptoms associated with migraine after 8 weeks of product intake

    Mean change in symptoms measured using a 5-likert scale

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

  4. 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)

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

  5. 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

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

  6. • 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

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

  7. Evaluate the effect on patient tolerance after 8 weeks of product intake

    Mean change in number of Adverse events (AE)

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

  8. 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)

    Measured: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)

  9. 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

    Measured: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)

  10. 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

    Measured: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)

  11. 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

    Measured: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)

  12. 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)

    Measured: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)

  13. 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

    Measured: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)

  14. 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

    Measured: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)

  15. 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)

    Measured: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)

  16. 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)

    Measured: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)

  17. 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

    Measured: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)

  18. 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

    Measured: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)

  19. 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

    Measured: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)

  20. 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)

    Measured: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)

  21. 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

    Measured: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)

  22. 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

    Measured: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)

  23. 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)

    Measured: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start15 May 2025
  3. Primary completion15 Dec 2025 (estimated)
  4. Study completion16 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015411
Sponsor's protocol ID
001
Acronym
NeuroCare
Status last verified
Jun 2025
First submitted
19 May 2025
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Neuro-Complex and Multi in people with Migraine Headache and Migraine, run by Benfida, a department of Handi-Move at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ine Vercammen (0032 15 79 27 97, ine.vercammen@meclinas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of migraine days per month (MDM) by 25% by using the combined supplementation with Neuro-Complex & Multi after 8 weeks of product intake (time frame: Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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