Back to resultsThe Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine
Primary Purpose
Migraine Disorders, Headache, Migraine, Migraine
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Triptan
Doxycycline
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders
Eligibility 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
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Triptan
Doxycycline
Triptan + Doxycycline
Control
Arm Description
Outcomes
Primary Outcome Measures
Serum neuroinflammatory marker concentrations
Secondary Outcome Measures
Headache intensity (four-point scale)
Number of participants with adverse events as a measure of safety and tolerability
Time to headache relief
Time to headache recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01653522
Brief Title
The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine
Official Title
The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Headache, Migraine, Migraine, Migraine Headache, Migraine With Aura, Migraine Without Aura, Headache Disorders, Primary
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triptan
Arm Type
Experimental
Arm Title
Doxycycline
Arm Type
Experimental
Arm Title
Triptan + Doxycycline
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Triptan
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Primary Outcome Measure Information:
Title
Serum neuroinflammatory marker concentrations
Secondary Outcome Measure Information:
Title
Headache intensity (four-point scale)
Title
Number of participants with adverse events as a measure of safety and tolerability
Title
Time to headache relief
Title
Time to headache recurrence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaheen E Lakhan, MD, PhD, MEd, MS
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine
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