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Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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.

NCT00293657•POZEN

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (23)

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

University of South Alabama Neurology

Mobile, Alabama, United States

Little Rock Family Practice Clinic

Little Rock, Arkansas, United States

C. Phillip O'Carroll, MD, Inc.

Newport Beach, California, United States

California Medical Clinic for Headache

Santa Monica, California, United States

New England Center for Headache

Stamford, Connecticut, United States

Meridien Research

St. Petersburg, Florida, United States

Premiere Research Institute

West Palm Beach, Florida, United States

Diamond Headache Clinic

Chicago, Illinois, United States

NE Medical Research Associates, Inc.

North Dartmouth, Massachusetts, United States

Key Dates

Start Date

December 1, 2005

Primary Completion Date

April 1, 2006

Completion Date

April 1, 2006

Last Updated

December 3, 2012

Enrollment

150

Estimated participants

Conditions

Headache (Migraine)

Interventions

Lornoxicam 8 mg

DRUG

Lornoxicam 16 mg

DRUG

Placebo

DRUG

App-based Breathing Program for Migraine Relief

NCT07297901

MigraineHeart Rate Variability (HRV)+6 more

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NOT_YET_RECRUITING

Prevalence and Determinants of Migraine Among Headache Patients

NCT07038499

Headache (Migraine)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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