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Prevention study for Migraine Headache
Official title Neuro-Complex & Multi Supplements for Migraine Prevention
ClinicalTrials.gov ID: NCT07015411
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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
You likely can't join 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...
- 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...
See the full eligibility criteria
Who can 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
- 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.
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mechelen, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mechelen, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.