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

NCT ID: NCT01653522

Last Updated: 2016-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Triptan

Group Type EXPERIMENTAL

Triptan

Intervention Type DRUG

Doxycycline

Group Type EXPERIMENTAL

Doxycycline

Intervention Type DRUG

Triptan + Doxycycline

Group Type EXPERIMENTAL

Triptan

Intervention Type DRUG

Doxycycline

Intervention Type DRUG

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Triptan

Intervention Type DRUG

Doxycycline

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaheen E Lakhan, MD, PhD, MEd, MS

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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12-061

Identifier Type: -

Identifier Source: org_study_id