NCT07015411 - Neuro-Complex & Multi Supplements for Migraine Prevention | Crick

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

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

Mean change of migraine days per month (MDM)

Time frame: Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation)

Secondary Outcomes

Evaluate the effect on migraine intensity/severity after 8 weeks of product intake

Mean change in migraine intensity/severity measured using a numerical rating scale 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

Mean change in migraine duration defined as start date and end date of each migraine episode captured by the patient

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

Mean change in symptoms measured using a 5-likert scale

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

Mean change in QoL assessed using self-reported questionnaire (SF-36)

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

Proportion of responders defined as patients with ≥50% reduction in MDM

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

Mean change in days of use of acute medication against migraine

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

Mean change in number of Adverse events (AE)

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)

Mean change of migraine days per month (MDM)

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)

Mean change in migraine intensity measured using a numerical rating scale

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)

Mean change in migraine duration defined as start date and end date of each migraine episode captured by the patient

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)

Mean change in symptoms measured using a 5-likert scale

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)

Mean change in QoL assessed using self-reported questionnaire (SF-36)

Time frame: 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)

Proportion of responders defined as patients with ≥50% reduction in MDM

Time frame: 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)

Mean change in days of use of acute medication against migraine

Time frame: 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)

Mean change in number of Adverse events (AE)

Time frame: 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)

Mean change of migraine days per month (MDM)