Headache Disorders, Primary, Headache, Migraine, Migraine, Migraine Disorders, Migraine Headache, Migraine With Aura, Migraine Without Aura
Conditions
Brief summary
The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.
Detailed description
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.
Interventions
DRUGTriptan
DRUGDoxycycline
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum neuroinflammatory marker concentrations | — |
Secondary
| Measure | 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 | — |
Countries
United States
Outcome results
None listed