Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine.

Summary

To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for the acute treatment of moderate or severe headache associated with a single migraine attack in patients with a history of migraine. Two-thirds of patients in this study will receive a single dose of intravenous lornoxicam (8mg or 16 mg) and one-third of patients will receive a single dose of an intravenous placebo.

Conditions

• Headache (Migraine)

Interventions

DRUG

Lornoxicam 8 mg

DRUG

Lornoxicam 16 mg

DRUG

Placebo

Sponsors & Collaborators

• POZEN

  lead INDUSTRY

Principal Investigators

• James Adelman, MD · Headache Wellness Center

• Sheena Aurora, MD · Swedish Pain Center

• Gary Berman, MD · Clinical Research Institute

• Roger Cady, MD · Headache Care Center

• Merle Diamond, MD · Diamond Headache Clinic

• Mildred Farmer, MD · Meridien Research

• Gregory Flippo, MD · Alabama Clinical Therapeutics

• Kevin Kahn, MD · University Headache Center

• David Kudrow, MD · California Medical Clinic for Headache

• Craig LaForce, MD · North Carolina Clinical Research

• Ninan Mathew, MD · The Houston Headache Clinic

• S. David Miller, MD · NE Medical Research Associates, Inc.

• C. Phillip O'Carroll, MD · C. Phillip O'Carroll, MD, Inc.

• Gilbert Podolsky, MD · Jean Brown Research

• Kevin Roberts, MD · Little Rock Family Practice Clinic

• John Rothrock, MD · University of South Alabama Neurology

• Todd Rozen, MD · Michigan Head Pain and Neurological Institute

• Stephan Sharp, MD · Clinical Research Associates, Inc.

• Fred Sheftell, MD · New England Center for Headache

• Stephen Silberstein, MD · Jefferson Headache Center

• Timothy Smith, MD · Mercy Health Research / Ryan Headache Center

• Stuart Stark, MD · The Innovative Clinical Research Center

• Paul Winner, DO · Premiere Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-12-31

Primary Completion

2006-04-30

Completion

2006-04-30

Countries

• United States

Study Locations