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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01653522
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : July 31, 2012
Last Update Posted : December 29, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Headache, Migraine Migraine Migraine Headache Migraine With Aura Migraine Without Aura Headache Disorders, Primary Drug: Triptan Drug: Doxycycline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine
Study Start Date : July 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: Triptan Drug: Triptan
Experimental: Doxycycline Drug: Doxycycline
Experimental: Triptan + Doxycycline Drug: Triptan
Drug: Doxycycline
No Intervention: Control

Primary Outcome Measures :
  1. Serum neuroinflammatory marker concentrations

Secondary Outcome Measures :
  1. Headache intensity (four-point scale)
  2. Number of participants with adverse events as a measure of safety and tolerability
  3. Time to headache relief
  4. Time to headache recurrence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653522

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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
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Principal Investigator: Shaheen E Lakhan, MD, PhD, MEd, MS The Cleveland Clinic
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01653522    
Other Study ID Numbers: 12-061
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders
Migraine without Aura
Migraine with Aura
Headache Disorders, Primary
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents