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

A Randomized, Double-Blind, Single-Dose Study, Placebo-Controlled Evaluation of the Safety and Efficacy of Intravenous Lornoxicam in the Acute Treatment of the Headache of Migraine.

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.

Study Overview

• Status: Completed
• Conditions: Headache (Migraine)
• Intervention / Treatment: Drug: Placebo; Drug: Lornoxicam 8 mg; Drug: Lornoxicam 16 mg

Detailed Description

The headache of migraine is the primary symptom of this disorder that is estimated to affect approximately 10% of the population of developed countries, with the majority of persons with migraine being females between the ages of 20 and 50 years. Patients with migraine desire rapid and complete relief from headache and decreased frequency of recurrence over the 24 hours after treatment. Current treatments for migraine often provide incomplete pain relief and additional acute treatments are needed. Lornoxicam is a member of the NSAID class of anti-inflammatory drugs and is shown to be effective in the acute management of postoperative pain and arthritis. The current study will evaluate the efficacy of single doses of lornoxicam, administered intravenously, in treatment of the headache of migraine to determine possible future uses of this drug in this condition.

• Study Type: Interventional
• Enrollment: 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics
    • Mobile, Alabama, United States, 36693
      • University of South Alabama Neurology
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Family Practice Clinic
  • California
    • Newport Beach, California, United States, 92660
      • C. Phillip O'Carroll, MD, Inc.
    • Santa Monica, California, United States, 90404
      • California Medical Clinic for Headache
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • New England Center for Headache
  • Florida
    • St. Petersburg, Florida, United States, 33709
      • Meridien Research
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Diamond Headache Clinic
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • NE Medical Research Associates, Inc.
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain and Neurological Institute
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Headache Care Center
    • St. Louis, Missouri, United States, 63141
      • Mercy Health Reserach / Ryan Headache Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University Headache Center
    • Greensboro, North Carolina, United States, 27401
      • Headache Wellness Center
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Headache Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
  • Texas
    • Houston, Texas, United States, 77004
      • Houston Headache Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • The Innovative Clinical Research Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Pain Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must have a demonstrated history of migraine headaches according to the International Headache Society (IHS) criteria 1.1 or 1.2 (2004), had their first migraine prior to age 50, and have had an average migraine headache frequency of 2-6 migraines per month, of moderate or severe pain intensity, in each of the last 6 months prior to screening.
• Subjects are willing to come to the study site when he/she has onset of the headache of migraine to receive an intravenous dose of study medication and is willing to remain in the investigator's clinic for at least 2 hours after the intravenous dose for collection of study data (Subject is discharged to home after 2 hour post-dose evaluations are completed).

Exclusion Criteria:

• Subjects who are pregnant.
• Subjects has known allergic reactions or intolerance to NSAIDs; any subject in whom aspirin or other non-steroidal anti-inflammatory/analgesic drugs induce the symptoms of asthma, rhinitis and nasal polyps.
• Subject is receiving any medications known or suspected to have drug interactions with lornoxicam. These include: warfarin or other anticoagulants, digoxin, probenecid, methotrexate, lithium, aspirin, cimetidine, cyclosporine and/or furosemide.
• Subjects with a non-migraine (i.e., tension-type, sinus, etc.) headache frequency of >15 days/month in each of the 3 months (90 days) prior to screening.
• Subjects experiencing greater than an average of 6 migraine attacks per month and/or >15 migraine days per month in the 6 months prior to screening.
• Subjects with a history of documented gastrointestinal ulceration in the past six months or hospitalization for gastrointestinal bleeding in the past year.
• Subjects with history of impaired renal function and/or a history of kidney disease, interstitial nephritis, nephrotic syndrome, and/or peripheral edema.
• Subjects with history of heart disease or certain related conditions.
• Subjects with uncontrolled hypertension or hypertension that is difficult to control with medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assessment of headache pain intensity over 24 hours after treatment, rated on a categorical scale of 0-3 and a visual analog scale (VAS).

Secondary Outcome Measures

Outcome Measure
Assessments of symptoms of photophobia, phonophobia, nausea and vomiting, rated as present or absent; use of rescue medication in the 24 hours after dosing; response of allodynia symptoms present at time of treatment.

Collaborators and Investigators

• Sponsor: POZEN
• Investigators: Principal Investigator: James Adelman, MD, Headache Wellness Center; Principal Investigator: Sheena Aurora, MD, Swedish Pain Center; Principal Investigator: Gary Berman, MD, Clinical Research Institute; Principal Investigator: Roger Cady, MD, Headache Care Center; Principal Investigator: Merle Diamond, MD, Diamond Headache Clinic; Principal Investigator: Mildred Farmer, MD, Meridien Research; Principal Investigator: Kevin Kahn, MD, University Headache Center; Principal Investigator: David Kudrow, MD, California Medical Clinic for Headache; Principal Investigator: Craig LaForce, MD, North Carolina Clinical Research; Principal Investigator: Ninan Mathew, MD, The Houston Headache Clinic; Principal Investigator: S. David Miller, MD, NE Medical Research Associates, Inc.; Principal Investigator: C. Phillip O'Carroll, MD, C. Phillip O'Carroll, MD, Inc.; Principal Investigator: Gilbert Podolsky, MD, Jean Brown Research; Principal Investigator: Kevin Roberts, MD, Little Rock Family Practice Clinic; Principal Investigator: John Rothrock, MD, University of South Alabama Neurology; Principal Investigator: Todd Rozen, MD, Michigan Head Pain and Neurological Institute; Principal Investigator: Stephan Sharp, MD, Clinical Research Associates, Inc.; Principal Investigator: Fred Sheftell, MD, New England Center for Headache; Principal Investigator: Stephen Silberstein, MD, Jefferson Headache Center; Principal Investigator: Timothy Smith, MD, Mercy Health Research / Ryan Headache Center; Principal Investigator: Stuart Stark, MD, The Innovative Clinical Research Center; Principal Investigator: Paul Winner, DO, Premiere Research Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: February 15, 2006
• First Submitted That Met QC Criteria: February 15, 2006
• First Posted (Estimate): February 17, 2006

Study Record Updates

• Last Update Posted (Estimate): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Piroxicam; Lornoxicam
• Other Study ID Numbers: LNP-201