The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine
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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 |
- Serum neuroinflammatory marker concentrations [ Designated as safety issue: No ]
- 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 2012 (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 |
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| Contact: Shaheen E Lakhan, MD, PhD, MEd, MS | lakhans2@ccf.org |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| 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: | July 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Migraine Disorders Migraine with Aura Migraine without Aura Headache Headache Disorders Headache Disorders, Primary Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Brain Diseases |
Central Nervous System Diseases Doxycycline Doxycycline hyclate Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 19, 2013