The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.

Detailed Description
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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.

Official Title
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The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine

Conditions
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Migraine Disorders, Headache, Migraine, Migraine, Migraine Headache, Migraine With Aura, Migraine Without Aura, Headache Disorders, Primary

Intervention / Treatment
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* Drug: Triptan
* Drug: Doxycycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of migraine with or without aura that fulfill the 2nd Edition of The International Headache Classification (ICHD-II) criteria Active prescription for an oral triptan medication to abort acute migraines Exclusion Criteria: Tetracycline group or other anti-inflammatory medication use in the preceding three months Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triptan<br> | Drug: Triptan<br> <br> |
| Experimental: Doxycycline<br> | Drug: Doxycycline<br> <br> |
| Experimental: Triptan + Doxycycline<br> | Drug: Triptan<br> <br> Drug: Doxycycline<br> <br> |
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum neuroinflammatory marker concentrations |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 
| Time to headache recurrence |  |  |