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

Overview

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).

Interventions

• Dietary supplement Neuro-Complex and Multi
  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.

Primary outcome measures

• 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)]

Secondary outcome measures (12)

• Evaluate the effect on migraine intensity/severity after 8 weeks of product intake [Time frame: Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)]
• Evaluate the effect on migraine duration after 8 weeks of product intake [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)]
• Evaluate the effect on patient tolerance after 8 weeks of product intake [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Between Baseline (V0) and Week 16 (after 8 weeks of non-supplementation followed by 8 weeks of supplementation)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Belgium · 1 center

• Meclinas — Mechelen

Identifiers

NCT: NCT07015411 · 001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗