ClinicalTrials.Veeva

Menu

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

G

Gary E. Ruoff, M.D.

Status

Completed

Conditions

Migraine

Treatments

Drug: sumatriptan and Treximet

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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).

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Imitrex and Treximet
Description:
Imitrex 100mg as needed Treximet 85/500mg
Treatment:
Drug: sumatriptan and Treximet

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems