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

NCT ID: NCT00293657

Last Updated: 2012-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Headache (Migraine)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lornoxicam 8 mg

Intervention Type DRUG

Lornoxicam 16 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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POZEN

INDUSTRY

Sponsor Role lead

Principal Investigators

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James Adelman, MD

Role: PRINCIPAL_INVESTIGATOR

Headache Wellness Center

Sheena Aurora, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Pain Center

Gary Berman, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Institute

Roger Cady, MD

Role: PRINCIPAL_INVESTIGATOR

Headache Care Center

Merle Diamond, MD

Role: PRINCIPAL_INVESTIGATOR

Diamond Headache Clinic

Mildred Farmer, MD

Role: PRINCIPAL_INVESTIGATOR

Meridien Research

Gregory Flippo, MD

Role: PRINCIPAL_INVESTIGATOR

Alabama Clinical Therapeutics

Kevin Kahn, MD

Role: PRINCIPAL_INVESTIGATOR

University Headache Center

David Kudrow, MD

Role: PRINCIPAL_INVESTIGATOR

California Medical Clinic for Headache

Craig LaForce, MD

Role: PRINCIPAL_INVESTIGATOR

North Carolina Clinical Research

Ninan Mathew, MD

Role: PRINCIPAL_INVESTIGATOR

The Houston Headache Clinic

S. David Miller, MD

Role: PRINCIPAL_INVESTIGATOR

NE Medical Research Associates, Inc.

C. Phillip O'Carroll, MD

Role: PRINCIPAL_INVESTIGATOR

C. Phillip O'Carroll, MD, Inc.

Gilbert Podolsky, MD

Role: PRINCIPAL_INVESTIGATOR

Jean Brown Research

Kevin Roberts, MD

Role: PRINCIPAL_INVESTIGATOR

Little Rock Family Practice Clinic

John Rothrock, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Alabama Neurology

Todd Rozen, MD

Role: PRINCIPAL_INVESTIGATOR

Michigan Head Pain and Neurological Institute

Stephan Sharp, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Associates, Inc.

Fred Sheftell, MD

Role: PRINCIPAL_INVESTIGATOR

New England Center for Headache

Stephen Silberstein, MD

Role: PRINCIPAL_INVESTIGATOR

Jefferson Headache Center

Timothy Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Health Research / Ryan Headache Center

Stuart Stark, MD

Role: PRINCIPAL_INVESTIGATOR

The Innovative Clinical Research Center

Paul Winner, DO

Role: PRINCIPAL_INVESTIGATOR

Premiere Research Institute

Locations

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Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Site Status

University of South Alabama Neurology

Mobile, Alabama, United States

Site Status

Little Rock Family Practice Clinic

Little Rock, Arkansas, United States

Site Status

C. Phillip O'Carroll, MD, Inc.

Newport Beach, California, United States

Site Status

California Medical Clinic for Headache

Santa Monica, California, United States

Site Status

New England Center for Headache

Stamford, Connecticut, United States

Site Status

Meridien Research

St. Petersburg, Florida, United States

Site Status

Premiere Research Institute

West Palm Beach, Florida, United States

Site Status

Diamond Headache Clinic

Chicago, Illinois, United States

Site Status

NE Medical Research Associates, Inc.

North Dartmouth, Massachusetts, United States

Site Status

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, United States

Site Status

Clinical Research Institute

Plymouth, Minnesota, United States

Site Status

Headache Care Center

Springfield, Missouri, United States

Site Status

Mercy Health Reserach / Ryan Headache Center

St Louis, Missouri, United States

Site Status

University Headache Center

Chapel Hill, North Carolina, United States

Site Status

Headache Wellness Center

Greensboro, North Carolina, United States

Site Status

North Carolina Clinical Research

Raleigh, North Carolina, United States

Site Status

Jefferson Headache Center

Philadelphia, Pennsylvania, United States

Site Status

Clinical Research Associates, Inc.

Nashville, Tennessee, United States

Site Status

Houston Headache Clinic

Houston, Texas, United States

Site Status

Jean Brown Research

Salt Lake City, Utah, United States

Site Status

The Innovative Clinical Research Center

Alexandria, Virginia, United States

Site Status

Swedish Pain Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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LNP-201

Identifier Type: -

Identifier Source: org_study_id