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NCT01653522 Clinical Trial

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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01653522
Other study ID # 12-061
Secondary ID
Status Withdrawn
Phase N/A
First received July 23, 2012
Last updated December 27, 2016
Start date July 2012
Est. completion date July 2014

Study information
Verified date December 2016
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Triptan

• Doxycycline

Locations
Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum neuroinflammatory marker concentrations No
Secondary Headache intensity (four-point scale) No
Secondary Number of participants with adverse events as a measure of safety and tolerability No
Secondary Time to headache relief
Secondary Time to headache recurrence
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