NCT07015411RecruitingNot Applicable
Effectiveness of an Orally Administered and Combined Neuro-Complex & Multi Supplements in the Prevention of Migraine in Adult
Benfida, a department of Handi-Move1 site in 1 country120 target enrollmentStarted: May 15, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Reduction of migraine days per month (MDM) by 25% by using the combined supplementation with Neuro-Complex & Multi after 8 weeks of product intake
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Supplementation Arm - Neuro-Complex and Multi Combination
Experimental
Intervention: Neuro-Complex and Multi (Dietary Supplement)
Outcomes
Primary Outcomes
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)
Mean change of migraine days per month (MDM)
Secondary Outcomes
- 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 reduction in the use of acute medication for migraine after 8 weeks of product intake(Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation))
- Evaluate the effect on patient tolerance 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))
- Evaluate the effect on migraine days per month (MDM) after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)(Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation))
- Evaluate the effect on migraine intensity/severity after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)(Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation))
- Evaluate the effect on migraine duration after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)(Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation))
- Evaluate the effect on symptoms associated with migraine after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)(Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation))
- Evaluate the effect on quality of life (QoL) after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)(Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation))
- Evaluate the effect on number of responders to the supplementation after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)(Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation))
- 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)(Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation))
- Evaluate the effect on patient tolerance after 16 weeks (8 weeks without supplementation followed by 8 weeks of supplementation)(Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation))
- 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)(Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16))
- Compare the effect on migraine intensity/severity between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)(Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16))
- Compare the effect on migraine duration between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)(Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16))
- 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)(Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16))
- 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)(Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16))
- 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)(Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16))
- 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)(Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16))
- Compare the effect on patient tolerance between the non-supplementation period (baseline to 8 weeks) and the supplementation period (8 to 16 weeks)(Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16))
Investigators
Study Sites (1)
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