Migraine, Migraine Headache, Migraine in Adults
Conditions
Keywords
Migraine, Neuro-Complex, Multi, Supplement, headache, nutrients
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).
Interventions
DIETARY_SUPPLEMENTNeuro-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.
Sponsors
Artialis
Benfida, a department of Handi-Move
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of migraine days per month (MDM) by 25% by using the combined supplementation with Neuro-Complex & Multi after 8 weeks of product intake | Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation) | Mean change of migraine days per month (MDM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect on migraine duration after 8 weeks of product intake | Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation) | Mean change in migraine duration defined as start date and end date of each migraine episode captured by the patient |
| 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) | Mean change in symptoms measured using a 5-likert scale |
| 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) | Mean change in QoL assessed using self-reported questionnaire (SF-36) |
| 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) | Proportion of responders defined as patients with ≥50% reduction in MDM |
| • 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) | Mean change in days of use of acute medication against migraine |
| Evaluate the effect on patient tolerance after 8 weeks of product intake | Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation) | Mean change in number of Adverse events (AE) |
| 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) | Mean change of migraine days per month (MDM) |
| 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) | Mean change in migraine intensity measured using a numerical rating scale |
| 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) | Mean change in migraine duration defined as start date and end date of each migraine episode captured by the patient |
| 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) | Mean change in symptoms measured using a 5-likert scale |
| 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) | Mean change in QoL assessed using self-reported questionnaire (SF-36) |
| 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) | Mean change in migraine intensity/severity measured using a numerical rating scale after 8 weeks of product intake |
| 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) | Mean change in days of use of acute medication against migraine |
| 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) | Mean change in number of Adverse events (AE) |
| 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) | Mean change of migraine days per month (MDM) |
| 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) | Mean change in migraine intensity measured using a numerical rating scale |
| 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) | Mean change in migraine duration defined as start date and end date of each migraine episode captured by the patient |
| 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) | Mean change in symptoms measured using a 5-likert scale |
| 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) | Mean change in QoL assessed using self reported questionnaire (SF-36) |
| 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) | Proportion of responders defined as patients with ≥50% reduction in MDM |
| 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) | Mean change in days of use of acute medication against migraine |
| 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) | Mean change in number of Adverse events (AE) |
| 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) | Proportion of responders defined as patients with ≥50% reduction in MDM |
Countries
Belgium
Contacts
Primary ContactIne Vercammen
Backup ContactElisa Debien
Outcome results
None listed