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

NCT01916395 | Completed DMC

• 1 other identifier: GR10
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Migraine

Outcome Measures

Primary Outcomes (1)

• The outcome will be to determine whether inflammatory markers are reduced in patients having a migraine when treated with Imitrex 100mg or Treximet.

  6 months

Study Arms (1)

Imitrex and Treximet

Imitrex 100mg as needed Treximet 85/500mg

Drug: sumatriptan and Treximet

Interventions

sumatriptan and Treximet DRUG

sumatriptan 100mg tablet when migraine is moderate or severe in intensity. Treximet 85/500mg tablet when migraine is moderate or severe in intensity.

Also known as: Imitrex 100mg, Treximet 85/500mg

Imitrex and Treximet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female patients with migraine headaches.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gary E. Ruoff, M.D.: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Westside Family Medical Center, PC

Kalamazoo, Michigan, 49009, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan; sumatriptan-naproxen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gary E Ruoff, MD

  Family Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 5, 2013
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: July 1, 2011
• Last Updated: August 5, 2013

Record last verified: 2009-12

Locations

US (1)