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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2014 by The Cleveland Clinic.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Shaheen Lakhan, MD, PhD, MEd, MS, The Cleveland Clinic Identifier:
First received: July 23, 2012
Last updated: April 20, 2014
Last verified: April 2014
The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.

Condition Intervention
Migraine Disorders
Headache, Migraine
Migraine Headache
Migraine With Aura
Migraine Without Aura
Headache Disorders, Primary
Drug: Triptan
Drug: Doxycycline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Serum neuroinflammatory marker concentrations [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Headache intensity (four-point scale) [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Designated as safety issue: No ]
  • Time to headache relief
  • Time to headache recurrence

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triptan Drug: Triptan
Experimental: Doxycycline Drug: Doxycycline
Experimental: Triptan + Doxycycline Drug: Triptan Drug: Doxycycline
No Intervention: Control

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT01653522

Contact: Shaheen E Lakhan, MD, PhD, MEd, MS

United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Shaheen E Lakhan, MD, PhD, MEd, MS The Cleveland Clinic
  More Information

Responsible Party: Shaheen Lakhan, MD, PhD, MEd, MS, The Cleveland Clinic Identifier: NCT01653522     History of Changes
Other Study ID Numbers: 12-061 
Study First Received: July 23, 2012
Last Updated: April 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache Disorders
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents processed this record on May 30, 2016