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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):
Drs Barbara Peterlin, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01138150
First received: June 3, 2010
Last updated: October 22, 2014
Last verified: August 2011
  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: sumatriptan/naproxen sodium
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group 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:
  • Blood levels of proteins will be evaluated at baseline when subjects are pain-free and then repeated during an acute attack, both prior to drug administration and then at 30 minutes, 1 hour and 2 hours after acute treatment. [ Time Frame: one year ] [ Designated as safety issue: No ]

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 Drug: sumatriptan/naproxen sodium
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
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

No publications provided

Responsible Party: Drs Barbara Peterlin, Director, The Johns Hopkins Bayview Headache Research, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01138150     History of Changes
Obsolete Identifiers: NCT00868322
Other Study ID Numbers: GSK112035
Study First Received: June 3, 2010
Last Updated: October 22, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014