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The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.
Increased inflammatory cytokines and matrix metalloproteinases (MMPs) have been recently implicated in migraine. Inflammation may be a key player in the pathophysiology of migraine by altering blood-brain barrier (BBB) function. As an inflammation induced MMP, MMP-9 is involved in both BBB disruption and neuropathic pain, and is largely derived by neutrophil degranulation during neutrophil-BBB interaction. The tetracycline group of antibiotics may suppress MMP production and neutrophil degranulation. This study aims to investigate known neuroinflammatory biomarkers with a focus on BBB breakdown during acute migraine attacks and assess marker responses to conventional treatment (triptans) and novel MMP targeted therapy (doxycycline). This pilot project data will supplement future projects investigating novel therapeutic strategies such as MMP inhibitors in both migraine acute treatment and prevention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptan | Experimental |
| |
| Doxycycline | Experimental |
| |
| Triptan + Doxycycline | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptan | Drug |
| ||
| Doxycycline |
| Measure | Description | Time Frame |
|---|---|---|
| Serum neuroinflammatory marker concentrations |
| Measure | Description | Time Frame |
|---|---|---|
| Headache intensity (four-point scale) | ||
| Number of participants with adverse events as a measure of safety and tolerability | ||
| Time to headache relief |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaheen E Lakhan, MD, PhD, MEd, MS | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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|
| Time to headache recurrence |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| D051270 | Headache Disorders, Primary |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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