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Ictal and Interictal Inflammatory Markers in Migraine

This study has been completed.
Sponsor:
Collaborators:
University of Toledo Health Science Campus
The Cleveland Clinic
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01138150
First received: June 3, 2010
Last updated: August 15, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to evaluate blood levels of several proteins that may be altered in the inflammation associated with migraine headaches. These blood levels will be evaluated in individuals during an acute migraine attack and compared to their levels when pain free. The investigators study hypothesis is that the pro inflammatory proteins in the blood will be greater than the levels of these proteins when evaluated during a pain free period.

Condition Intervention Phase
Migraine
Drug: Treximet
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Ictal and Interictal Inflammatory Markers in Migraine

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Change in the Total Serum Adiponectin (T-ADP) [ Time Frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment ] [ Designated as safety issue: No ]
    Change in total serum adiponectin after treatment in responders and non responders


Secondary Outcome Measures:
  • High Molecular Weight (HMW)-Adiponectin (ADP) [ Time Frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment ] [ Designated as safety issue: No ]
    serum HMW-ADP levels after treatment in responders and non responders

  • Middle Molecular Weight (MMW)-ADP [ Time Frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment ] [ Designated as safety issue: No ]
    serum MMW-ADP levels after treatment in responders and non responders

  • Low Molecular Weight (LMW)-ADP [ Time Frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment ] [ Designated as safety issue: No ]
    serum LMW-ADP levels after treatment in responders and non responders

  • High Molecular Weight (HMW): T-ADP [ Time Frame: 30 minutes, 60 minutes, 120 minutes after treatment ] [ Designated as safety issue: No ]
    serum HMW:T-ADP levels after treatment in responders and non responders

  • Low Molecular Weight (LMW):Total (T)-ADP [ Time Frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment ] [ Designated as safety issue: No ]
    serum LMW:T-ADP levels after treatment in responders and non responders

  • Leptin [ Time Frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment ] [ Designated as safety issue: No ]
    serum leptin levels after treatment in responders and non responders

  • Resistin [ Time Frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment ] [ Designated as safety issue: No ]
    serum resistin levels after treatment in responders and non responders


Enrollment: 36
Study Start Date: September 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treximet

Fourteen participants randomized to receive Treximet (sumatriptan & naproxen) during an acute migraine attack. Blood drawn for immune & inflammatory markers (adipocytokines,cytokines, sex hormones) at different time points - on presentation with moderate to severe migraine pain; then 30 minutes, 1 hour and 2 hours after administration of study drug (Treximet).

Participants will be offered a traditional headache rescue medicine at 2 hours after administration of Treximet if participant still reports moderate to severe pain and desires further treatment. Rescue medicine may include the following: prochlorperazine 10 mg IV preceded by diphenhydramine 25 mg IV/PO or metoclopramide 10 mg IV preceded by diphenhydramine 25 mg IV/PO or Toradol 30 mg IV to be determined by the physician.

Drug: Treximet
One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
Other Name: The brand name of sumatriptan/naproxen sodium is Treximet.
Placebo Comparator: Sugar Pill

Fourteen participants randomized to receive placebo during an acute migraine attack. Blood is drawn for immune & inflammatory markers (adipocytokines,cytokines), sex hormones at different time points - on presentation with moderate to severe migraine pain, then 30 minutes, 1 hour and 2 hours after administration of placebo.

Participants will be offered a traditional headache rescue medicine at 2 hours after administration of placebo if participant still reports moderate to severe pain and desires further treatment. Rescue medicine may include the following: prochlorperazine 10 mg IV preceded by diphenhydramine 25 mg IV/PO or metoclopramide 10 mg IV preceded by diphenhydramine 25 mg IV/PO or Toradol 30 mg IV to be determined by the physician.

Drug: Placebo
One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
Other Name: Sugar Pill

Detailed Description:
Migraine is a common, chronic disorder, which presents with recurrent episodes of disabling headache and affects approximately 12% of American adults.1,2 No biomarkers exist to identify episodic or chronic migraine sufferers; and the diagnosis relies solely on clinical criteria. Further the full pathophysiology of migraine has not been fully delineated, although our understanding of migraine pathophysiology has dramatically improved over the past 15 years. Current theories suggest that migraine is a neurovascular disorder, with the pain of migraine a result of the release of inflammatory neuropeptides from nerve endings in the activated trigeminal system (neurogenic inflammation), ultimately resulting in vasodilation, plasma extravasation and mast cell degranulation.3-6 Several inflammatory markers have been implicated in the pathway resulting in the neurogenic inflammation of migraine including calcitonin gene related peptide (CGRP), substance P (SP), neurokinin A, and multiple cytokines such as interleukin (IL) -1, IL-6 and tumor necrosis-α (TNF-α).5,7-10 More recent research supports that the odds of migraine are increased in those who are obese and that several adipose tissue derived cytokines (adipocytokines) may contribute to the neurogenic inflammation of migraine, including leptin and adiponectin. In one small pilot study of 33 participants evaluating chronic and episodic migraineurs as compared to controls, adiponectin (an adipocytokine) was significantly elevated in chronic migraineurs as compared to controls. A second study reported low levels of another adipocytokine, leptin in episodic migraineurs. However, all of these studies have evaluated only 3 to 4 of cytokines at the same time point and 11 none have evaluated adipocytokines during an acute attack. We hypothesize that obesity-related cytokines contribute to the neurogenic inflammation of migraine and have the potential be useful as biomarkers for episodic and chronic migraine as well as new drug targets for the treatment of migraine. To this end we propose to evaluate serum levels of obesity-related cytokines in migraineurs, ictally (during an acute migraine attack), following treatment with sumatriptan/naproxen sodium (Treximet®) and interictally (at baseline) when pain free.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 18 years of age, migraine

Exclusion Criteria:

  • Pregnant or breast-feeding women, presence of cardiovascular or cerebrovascular disorders as well as any known inflammatory, infectious, metabolic, thyroid, renal, cardiovascular or gastrointestinal diseases
  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: NCT01138150

Locations
United States, Maryland
The Johns Hopkins Bayview Headache Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
University of Toledo Health Science Campus
The Cleveland Clinic
Investigators
Principal Investigator: Barbara L Peterlin, DO The Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01138150     History of Changes
Obsolete Identifiers: NCT00868322
Other Study ID Numbers: GSK112035 
Study First Received: June 3, 2010
Results First Received: February 9, 2016
Last Updated: August 15, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
migraine, headache, sumatriptan, naproxen sodium

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Prochlorperazine
Naproxen
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipsychotic Agents

ClinicalTrials.gov processed this record on December 08, 2016