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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gary E. Ruoff, M.D.
• Collaborator: GlaxoSmithKline
• Treatments: Naproxen; Sumatriptan

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