Neuro-Complex and Multi supplements to prevent migraine
Effectiveness of an Orally Administered and Combined Neuro-Complex & Multi Supplements in the Prevention of Migraine in Adult
This trial will try whether taking Neuro-Complex and Multi supplements twice daily for 8 weeks reduces monthly migraine days in adults who have at least 6 headache days per month.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Benfida, a department of Handi-Move Industry-sponsored |
| Locations | 1 site (Mechelen) |
| Trial ID | NCT07015411 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, open-label, non-randomized single-arm study with an 8-week run-in period without supplementation followed by 8 weeks of active supplementation. Participants will take the assigned Neuro-Complex and Multi products orally twice daily (morning and lunchtime) for the 8-week treatment period. The primary outcome is the mean change in migraine days per month after 8 weeks of supplementation compared with the run-in period. The trial enrolls adults with migraine meeting ICHD-3 criteria and at least 6 headache days per month.
Who should consider this trial
Good fit: Adults aged 18–75 with a diagnosis of migraine per ICHD-3 and at least 6 headache days per month, with stable BMI and stable migraine medications, are the intended participants.
Not a fit: People with fewer than 6 headache days per month, those with secondary headache disorders, recent changes in migraine medications, or who cannot comply with the dosing or visits are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the supplements could reduce the number of monthly migraine days (the trial aims for about a 25% reduction).
How similar studies have performed: Some individual nutritional supplements (for example magnesium, riboflavin, coenzyme Q10) have shown modest benefits in prior trials, but the combined Neuro-Complex & Multi regimen is a relatively novel, less-studied approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mechelen
- Meclinas — Mechelen, Belgium (Recruiting)
Study contacts
- Study coordinator: Ine Vercammen
- Email: ine.vercammen@meclinas.com
- Phone: 0032 15 79 27 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.