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The purpose of this study is to evaluate the impact of the Migraceutics® phase-specific dietary supplement regimen on quality of life, work productivity, and biomarkers in adult migraineurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Care as usual (CAU) | No Intervention | ||
| Arm 2 - Care as usual (CAU) + Reference dietary supplement | Sham Comparator |
| |
| Arm 3 - Care as usual (CAU) + Foundational dietary supplement | Other |
| |
| Arm 4a - Care as usual (CAU) + Foundational dietary supplement + Migraine phase add-on supplement | Other |
| |
| Arm 4b - Care as usual (CAU) + Foundational dietary supplement + Luteal phase add-on supplement | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foundational dietary supplement | Dietary Supplement | Foundational dietary supplement, self-administered daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in migraine-related quality of life | Changes from baseline in migraine-related quality of life as measured by the mean Headache Impact Test (HIT-6) total score. HIT-6 has six questions, which are rated using a five-level scale: Never (6 points), Rarely (8 points), Sometimes (10 points), Very Often (11 points), and Always (13 points). Total scores can range from 36 to 78, with higher totals reflecting a more significant impact. | Baseline, Month 1 through Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of self-reported migraine days per month | The number of calendar days within a 28-day (or pre-specified) period on which a participant experiences any migraine. | Baseline, Month 1 through Month 6 |
| Distribution of participants experiencing changes in monthly migraine days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in systemic CGRP concentrations | Mean systemic CGRP concentrations. | Baseline, Month 1 through Month 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Contact | 443-220-3558 | info@migraceutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Natural Migraceuticals | Lutherville-Timonium | Maryland | 21093 | United States |
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| Luteal phase dietary supplement add-on | Dietary Supplement | Add-on dietary supplement, self-administered to women with menstrual migraine during the luteal phase of their menstruation cycle. |
|
| Migraine phase dietary supplement add-on | Dietary Supplement | Add-on dietary supplement, self-administered during the symptomatic migraine phase. |
|
| Reference dietary supplement | Dietary Supplement | Reference comparator supplement, self-administered daily. |
|
Distribution of participants in various levels of change (e.g., ≥25%, ≥50%, ≥75%, 100% change) from baseline. |
| Baseline, Month 1 through Month 6 |
| Use of over-the-counter or prescription migraine or headache medication | Mean number of migraine days associated with use of over-the-counter or prescription migraine or headache medication | Baseline, Month 1 through Month 6 |
| Migraine symptoms participants experienced | Mean monthly number of migraine symptoms. | Baseline, Month 1 through Month 6 |
| Self-reported migraine symptom severity | Self-reported migraine symptom severity scores. Participants rate each of their reported symptoms on a scale from 0 to 10 how bad these symptoms were at their worst. 0: I did not have this symptom, and 10: it was the worst imaginable | Baseline, Month 1 through Month 6 |
| Mean number of migraine hours | Mean number of hours in the past 30 days on which a migraine occurred | Baseline, Month 1 through Month 6 |
| Number of missed work and/or school days due to migraine | Number of missed work and/or school days per month (self-reported) | Baseline, Month 1 through Month 6 |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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