Clinical trial NCT07015411: Neuro-Complex & Multi Supplements for Migraine Prevention
Official title: Effectiveness of an Orally Administered and Combined Neuro-Complex & Multi Supplements in the Prevention of Migraine in Adult
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine Headache
Migraine
Migraine in Adults
Keywords: Migraine
Neuro-Complex
Multi
Supplement
headache
nutrients
Lead sponsor: Benfida, a department of Handi-Move
Sponsor class: INDUSTRY
Collaborators: name: Artialis
First posted: 2025-06-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
Secondary outcomes:
measure: Evaluate the effect on migraine intensity/severity after 8 weeks of product intake
timeFrame: Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
measure: Evaluate the effect on migraine duration after 8 weeks of product intake
timeFrame: Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
measure: Evaluate the effect on symptoms associated with migraine after 8 weeks of product intake
timeFrame: Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
measure: Evaluate the effect on quality of life (QoL) after 8 weeks of product intake
timeFrame: Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
measure: Evaluate the effect on number of responders to the supplementation after 8 weeks of product intake
timeFrame: Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
measure: • Evaluate the effect on reduction in the use of acute medication for migraine after 8 weeks of product intake
timeFrame: Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
measure: Evaluate the effect on patient tolerance after 8 weeks of product intake
timeFrame: Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)
measure: Evaluate the effect on migraine days per month (MDM) after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)
timeFrame: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
measure: Evaluate the effect on migraine intensity/severity after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)
timeFrame: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
measure: Evaluate the effect on migraine duration after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)
timeFrame: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
measure: Evaluate the effect on symptoms associated with migraine after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)
timeFrame: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
measure: Evaluate the effect on quality of life (QoL) after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)
timeFrame: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
measure: Evaluate the effect on number of responders to the supplementation after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)
timeFrame: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
measure: 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)
timeFrame: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
measure: Evaluate the effect on patient tolerance after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)
timeFrame: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)
measure: 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)
timeFrame: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
measure: Compare the effect on migraine intensity/severity between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)
timeFrame: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
measure: Compare the effect on migraine duration between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)
timeFrame: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
measure: 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)
timeFrame: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
measure: 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)
timeFrame: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
measure: 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)
timeFrame: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
measure: 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)
timeFrame: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
measure: Compare the effect on patient tolerance between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)
timeFrame: Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16)
Other outcomes:
Locations:
city: Mechelen
country: Belgium
facility: Meclinas
Study officials:
References: