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| Name | Class |
|---|---|
| Artialis | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplementation Arm - Neuro-Complex and Multi Combination | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuro-Complex and Multi | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Between Week 8 (V1) and Week 16 (after 8 weeks of supplementation) |
| Evaluate the effect on migraine duration after 8 weeks of product intake |
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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
During headache at least one of the following:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ine Vercammen | Contact | 0032 15 79 27 97 | ine.vercammen@meclinas.com | |
| Elisa Debien | Contact | 0032 15 79 27 97 | elisa.debien@meclinas.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meclinas | Recruiting | Mechelen | 2800 | Belgium |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
Mean change in migraine duration defined as start date and end date of each migraine episode captured by the patient |
| 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 | 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) | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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) | 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 | 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 | 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) | 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) | 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) | Mean change in migraine intensity measured using a numerical rating scale | 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) | Mean change in migraine duration defined as start date and end date of each migraine episode captured by the patient | 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) | Mean change in symptoms measured using a 5-likert scale | 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) | Mean change in QoL assessed using self reported questionnaire (SF-36) | 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) | Proportion of responders defined as patients with ≥50% reduction in MDM | 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) | Mean change in days of use of acute medication against migraine | 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) | Mean change in number of Adverse events (AE) | Between the non-supplementation period (Baseline to Week 8) and the supplementation period (Week 8 to Week 16) |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |