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

Not Applicable

Withdrawn

• Conditions: Migraine Disorders; Headache, Migraine; Migraine; Migraine Headache; Migraine With Aura; Migraine Without Aura; Headache Disorders, Primary
• Interventions: Drug: Triptan; Drug: Doxycycline

• Registration Number: NCT01653522
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-31
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-27
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triptan	Triptan	-
Triptan + Doxycycline	Triptan	-
Doxycycline	Doxycycline	-
Triptan + Doxycycline	Doxycycline	-

Primary Outcome Measures

Name	Time	Method
Serum neuroinflammatory marker concentrations

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability
Time to headache relief
Time to headache recurrence
Headache intensity (four-point scale)

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States