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

NCT00293657 | Completed Phase 2

• 1 other identifier: LNP-201
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 23

Brief 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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Lornoxicam 8 mg DRUG

Lornoxicam 16 mg DRUG

Placebo DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• POZEN: lead

Study Sites (23)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

University of South Alabama Neurology

Mobile, Alabama, 36693, United States

Location

Little Rock Family Practice Clinic

Little Rock, Arkansas, 72205, United States

Location

C. Phillip O'Carroll, MD, Inc.

Newport Beach, California, 92660, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

New England Center for Headache

Stamford, Connecticut, 06902, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Diamond Headache Clinic

Chicago, Illinois, 60614, United States

Location

NE Medical Research Associates, Inc.

North Dartmouth, Massachusetts, 02747, United States

Location

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Clinical Research Institute

Plymouth, Minnesota, 55441, United States

Location

Headache Care Center

Springfield, Missouri, 65807, United States

Location

Mercy Health Reserach / Ryan Headache Center

St Louis, Missouri, 63141, United States

Location

University Headache Center

Chapel Hill, North Carolina, 27599, United States

Location

Headache Wellness Center

Greensboro, North Carolina, 27401, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Houston Headache Clinic

Houston, Texas, 77004, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

The Innovative Clinical Research Center

Alexandria, Virginia, 22304, United States

Location

Swedish Pain Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

lornoxicam

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

• Gregory Flippo, MD

  Alabama Clinical Therapeutics

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: February 17, 2006
• Study Start: December 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

US (23)