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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Shaheen Lakhan, MD, PhD, MEd, MS, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01653522
First received: July 23, 2012
Last updated: April 20, 2014
Last verified: April 2014
  Purpose

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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653522

Contacts
Contact: Shaheen E Lakhan, MD, PhD, MEd, MS lakhans2@ccf.org

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

No publications provided

Responsible Party: Shaheen Lakhan, MD, PhD, MEd, MS, The Cleveland Clinic
ClinicalTrials.gov 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:
Headache
Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache Disorders
Headache Disorders, Primary
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on September 14, 2014