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Comparison of Treximet & Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache

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ClinicalTrials.gov Identifier: NCT01916395
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : August 5, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Gary E. Ruoff, M.D., Westside Family Medical Center, P.C.

Brief Summary:

The primary objective is to determine whether inflammatory markers, such as C-Reactive Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP), or Substance P (SP) are reduced in patients having a migraine headache when treated with Imitrex or Treximet.

The secondary objective is to determine the effects of Imitrex and Treximet on C-Reactive Protein (CRP) in patients with active migraine headaches.


Condition or disease Intervention/treatment
Migraine Drug: sumatriptan and Treximet

Detailed Description:

Migraine is a neurovascular process involving the brain and related structures. Neuroinflammatory substances such as CRP, CGRP, VIP, SP, and prostaglandins are liberated during the migraine. Elevation of these markers may be associated with other conditions which contain an inflammatory component such as coronary artery disease. VIP is an inflammation and pain transmission, and thus are markers of sensory nociceptive neurons.

During this study, the subjects will have the following inflammation markers analyzed: C-Reactive Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP), and Substance P (SP).


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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Comparison of Treximet and Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache.
Study Start Date : December 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Group/Cohort Intervention/treatment
Imitrex and Treximet
Imitrex 100mg as needed Treximet 85/500mg
Drug: sumatriptan and Treximet
sumatriptan 100mg tablet when migraine is moderate or severe in intensity. Treximet 85/500mg tablet when migraine is moderate or severe in intensity.
Other Names:
  • Imitrex 100mg
  • Treximet 85/500mg




Primary Outcome Measures :
  1. The outcome will be to determine whether inflammatory markers are reduced in patients having a migraine when treated with Imitrex 100mg or Treximet. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Male and female patients with migraine headaches.
Criteria

Inclusion Criteria:

  • Subject must sign an informed consent
  • Males and females 18 - 65 years of age
  • Have episodic migraine headaches
  • Patients to satisfy the diagnosis of migraine headaches with aura, without aura or mixed
  • Must be able to differentiate migraine headaches from other headaches
  • Diagnosis of migraines for at least 6 months

Exclusion Criteria:

  • Any medical condition, in the opinion of the investigator, that would make the subject unsuitable for enrollment
  • Basilar or hemiplegic migraine headaches
  • Pregnant woman or a nursing mother
  • History (within 1 year) or current evidence of grug or alcohol abuse
  • More than 15 migraine headaches per month
  • Chronic daily headache
  • Chronic use of NonSteroidalAntiInglammatoryDrugs
  • Current participation in a research study or within the last 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916395


Locations
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United States, Michigan
Westside Family Medical Center, PC
Kalamazoo, Michigan, United States, 49009
Sponsors and Collaborators
Gary E. Ruoff, M.D.
GlaxoSmithKline
Investigators
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Principal Investigator: Gary E Ruoff, MD Family Practice

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Responsible Party: Gary E. Ruoff, M.D., Director of Clinical Research, Westside Family Medical Center, P.C.
ClinicalTrials.gov Identifier: NCT01916395     History of Changes
Other Study ID Numbers: GR10
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: December 2009
Keywords provided by Gary E. Ruoff, M.D., Westside Family Medical Center, P.C.:
Migraine
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Naproxen
Sumatriptan
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